[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656844":3},{"organization":4,"outcomesModule":7,"designInfo":144,"detailedDescription":152,"studyPopulation":143,"armGroups":153,"interventions":166,"overallOfficials":143,"centralContacts":180,"locations":190,"responsibleParty":221,"collaborators":143,"id":223,"slug":224,"hasResults":225,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":143,"eligibilityCriteria":229,"healthyVolunteers":225,"sex":230,"minAge":231,"maxAge":232,"enrollmentInfo":233,"targetDuration":143,"studyType":236,"phases":237,"briefSummary":239,"conditions":240,"keywords":243,"overallStatus":247,"whyStopped":143,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},{"fullName":5,"class":6},"Qilu Hospital of Shandong University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":143},[9],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in Mean Office Systolic Blood Pressure at the End of Treatment","Office systolic blood pressure will be measured three consecutive times at the study visit according to the standardized blood pressure measurement procedure. The arithmetic mean of the three measurements will be used as the mean office systolic blood pressure. The outcome will be calculated as the mean office systolic blood pressure at the end of the 5-week treatment period minus the corresponding baseline value and will be reported in mmHg.","Baseline and Day 35 (end of the 5-week treatment period)",[14,18,22,25,28,32,35,39,42,45,48,51,54,57,60,64,66,68,70,72,74,77,79,81,83,85,87,89,91,93,95,97,99,101,103,106,109,112,115,118,121,124,127,130,133,136,139],{"measure":15,"description":16,"timeFrame":17},"Change From Baseline in Mean Office Diastolic Blood Pressure at the End of Treatment","Office diastolic blood pressure will be measured three consecutive times at the study visit. The arithmetic mean of the three measurements will be used. The outcome will be calculated as the mean office diastolic blood pressure at the end of the 5-week treatment period minus the corresponding baseline value and will be reported in mmHg.","Baseline and Week 5 (end of the treatment period)",{"measure":19,"description":20,"timeFrame":21},"Mean Within-Session Change in Supine Systolic Blood Pressure","Supine systolic blood pressure will be measured 3 minutes before each treatment session, at 30 minutes during the session, and 3 minutes after the session. Changes from the pre-session measurement to the during-session and post-session measurements will be calculated and reported in mmHg.","At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment",{"measure":23,"description":24,"timeFrame":21},"Mean Within-Session Change in Supine Diastolic Blood Pressure","Supine diastolic blood pressure will be measured 3 minutes before each treatment session, at 30 minutes during the session, and 3 minutes after the session. Changes from the pre-session measurement to the during-session and post-session measurements will be calculated and reported in mmHg.",{"measure":26,"description":27,"timeFrame":21},"Mean Within-Session Change in Supine Heart Rate","Supine heart rate will be measured 3 minutes before each treatment session, at 30 minutes during the session, and 3 minutes after the session. Changes from the pre-session measurement to the during-session and post-session measurements will be calculated and reported in beats per minute.",{"measure":29,"description":30,"timeFrame":31},"Change From Baseline in Mean Office Systolic Blood Pressure at Follow-up Assessments","Office systolic blood pressure will be measured three consecutive times at each study visit, and the arithmetic mean will be used. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.","Baseline; Week 3 (after 20 treatment sessions); and Months 1, 3, and 6 after the end of treatment",{"measure":33,"description":34,"timeFrame":31},"Change From Baseline in Mean Office Diastolic Blood Pressure at Follow-up Assessments","Office diastolic blood pressure will be measured three consecutive times at each study visit, and the arithmetic mean will be used. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.",{"measure":36,"description":37,"timeFrame":38},"Change From Baseline in 24-Hour Mean Systolic Blood Pressure","Twenty-four-hour mean systolic blood pressure will be measured using ambulatory blood pressure monitoring. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.","Baseline; Week 3 (after 20 treatment sessions); Week 5 (end of the treatment period); and Months 1, 3, and 6 after the end of treatment",{"measure":40,"description":41,"timeFrame":38},"Change From Baseline in 24-Hour Mean Diastolic Blood Pressure","Twenty-four-hour mean diastolic blood pressure will be measured using ambulatory blood pressure monitoring. Change from baseline will be calculated separately at each prespecified post-baseline assessment and reported in mmHg.",{"measure":43,"description":44,"timeFrame":38},"Change From Baseline in the 5-Item International Index of Erectile Function Total Score","Erectile function will be assessed using the 5-item International Index of Erectile Function. The total score will be calculated according to the prespecified scoring method. Change from baseline will be calculated separately at each post-baseline assessment.",{"measure":46,"description":47,"timeFrame":38},"Percentage of Participants Answering Yes to Sexual Encounter Profile Question 2","Sexual Encounter Profile Question 2 asks whether the participant was able to insert the penis into the partner's vagina. The percentage of participants answering Yes will be calculated at each prespecified assessment.",{"measure":49,"description":50,"timeFrame":38},"Percentage of Participants Answering Yes to Sexual Encounter Profile Question 3","Sexual Encounter Profile Question 3 asks whether the participant's erection lasted long enough for successful intercourse. The percentage of participants answering Yes will be calculated at each prespecified assessment.",{"measure":52,"description":53,"timeFrame":38},"Percentage of Participants Answering Yes to the Global Assessment Question","Participants will answer whether the treatment received during the study improved their erections. The percentage of participants answering Yes will be calculated at each prespecified assessment.",{"measure":55,"description":56,"timeFrame":38},"Change From Baseline in the Self-Esteem and Relationship Questionnaire Score","Self-esteem and sexual relationship outcomes will be assessed using the Self-Esteem and Relationship questionnaire. Change from baseline will be calculated separately at each post-baseline assessment.",{"measure":58,"description":59,"timeFrame":38},"Change From Baseline in Erectile Hardness Score","Erection hardness will be assessed using the Erectile Hardness Score, ranging from Grade 1 to Grade 4, with higher grades indicating greater erection hardness. Change from baseline will be evaluated at each prespecified assessment.",{"measure":61,"description":62,"timeFrame":63},"Change From Baseline in Serum Nitric Oxide Level","The parameter will be measured according to the prespecified standardized assessment procedure. Change from baseline will be calculated separately at each post-baseline assessment.","Baseline; Week 5 (end of the treatment period); and Month 3 after the end of treatment",{"measure":65,"description":62,"timeFrame":63},"Change From Baseline in Serum Vascular Endothelial Growth Factor Level",{"measure":67,"description":62,"timeFrame":38},"Change From Baseline in Brachial Artery Flow-Mediated Dilation",{"measure":69,"description":62,"timeFrame":38},"Change From Baseline in Reactive Hyperemia Index",{"measure":71,"description":62,"timeFrame":38},"Change From Baseline in Penile Artery Resistance Index",{"measure":73,"description":62,"timeFrame":38},"Change From Baseline in Penile Artery Peak Systolic Velocity",{"measure":75,"description":76,"timeFrame":38},"Change From Baseline in Cardiac Index","The parameter will be measured using the prespecified hemodynamic assessment method. Change from baseline will be calculated separately at each post-baseline assessment.",{"measure":78,"description":76,"timeFrame":38},"Change From Baseline in Cardiac Output",{"measure":80,"description":76,"timeFrame":38},"Change From Baseline in Stroke Volume",{"measure":82,"description":76,"timeFrame":38},"Change From Baseline in Stroke Volume Index",{"measure":84,"description":76,"timeFrame":38},"Change From Baseline in Mean Arterial Pressure",{"measure":86,"description":76,"timeFrame":38},"Change From Baseline in SSVRI",{"measure":88,"description":76,"timeFrame":38},"Change From Baseline in Left Ventricular Stroke Work Index",{"measure":90,"description":76,"timeFrame":38},"Change From Baseline in Systemic Vascular Resistance Index",{"measure":92,"description":76,"timeFrame":38},"Change From Baseline in Ejection Phase Contractility Index",{"measure":94,"description":76,"timeFrame":38},"Change From Baseline in Inotropic State Index",{"measure":96,"description":76,"timeFrame":38},"Change From Baseline in Systemic Vascular Resistance",{"measure":98,"description":76,"timeFrame":38},"Change From Baseline in Total Vascular Resistance",{"measure":100,"description":76,"timeFrame":38},"Change From Baseline in Mean Heart Rate",{"measure":102,"description":76,"timeFrame":38},"Change From Baseline in Pulse Wave Velocity",{"measure":104,"description":105,"timeFrame":38},"Change From Baseline in Hamilton Anxiety Rating Scale Total Score","Anxiety severity will be assessed using the prespecified validated version of the Hamilton Anxiety Rating Scale (HAM-A). The total score will be calculated according to the standard scoring method, with higher scores indicating greater anxiety severity. Change from baseline will be calculated separately at each post-baseline assessment.",{"measure":107,"description":108,"timeFrame":38},"Change From Baseline in [Full Name of Depression Scale] Total Score","Depressive symptoms will be assessed using the prespecified validated version of the \\[full name and abbreviation of the depression scale\\]. The total score ranges from \\[minimum score\\] to \\[maximum score\\], with higher scores indicating \\[greater or lower\\] depressive symptom severity. Change from baseline will be calculated separately at each post-baseline assessment.",{"measure":110,"description":111,"timeFrame":38},"Change From Baseline in Pittsburgh Sleep Quality Index Global Score","Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Change from baseline will be calculated separately at each post-baseline assessment.",{"measure":113,"description":114,"timeFrame":38},"Change From Baseline in 36-Item Short Form Health Survey Domain Scores","Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Eight domain scores will be calculated according to the standard scoring algorithm and transformed to a scale from 0 to 100, with higher scores indicating better health status. Change from baseline will be calculated separately for each domain at each post-baseline assessment.",{"measure":116,"description":117,"timeFrame":38},"Change From Baseline in the Standard Deviation of Normal-to-Normal Intervals","Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. The standard deviation of all normal-to-normal intervals (SDNN) will be calculated and reported in milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.",{"measure":119,"description":120,"timeFrame":38},"Change From Baseline in the Root Mean Square of Successive Normal-to-Normal Interval Differences","Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. The root mean square of successive normal-to-normal interval differences (RMSSD) will be calculated and reported in milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.",{"measure":122,"description":123,"timeFrame":38},"Change From Baseline in the Percentage of Successive Normal-to-Normal Intervals Differing by More Than 50 Milliseconds","Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. The percentage of successive normal-to-normal intervals differing by more than 50 milliseconds (pNN50) will be calculated and reported as a percentage. Change from baseline will be calculated separately at each prespecified post-baseline assessment.",{"measure":125,"description":126,"timeFrame":38},"Change From Baseline in Low-Frequency Power","Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. Low-frequency power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.",{"measure":128,"description":129,"timeFrame":38},"Change From Baseline in High-Frequency Power","Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. High-frequency power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.",{"measure":131,"description":132,"timeFrame":38},"Change From Baseline in Very-Low-Frequency Power","Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. Very-low-frequency power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.",{"measure":134,"description":135,"timeFrame":38},"Change From Baseline in Total Heart Rate Variability Power","Heart rate variability will be assessed using a 5-minute recording obtained with the participant resting in the supine position. Total heart rate variability power will be calculated using the prespecified frequency-domain analysis method and reported in square milliseconds. Change from baseline will be calculated separately at each prespecified post-baseline assessment.",{"measure":137,"description":138,"timeFrame":38},"Change From Baseline in the Number of Nocturia Episodes per Night","The number of nocturia episodes will be recorded based on the participant's report of the number of times the participant wakes from sleep to urinate during the usual nighttime sleep period. Change from baseline will be calculated separately at each prespecified post-baseline assessment.",{"measure":140,"description":141,"timeFrame":142},"Number of Participants With Adverse Events","All adverse events occurring after informed consent will be recorded and assessed for severity and relationship to the study intervention. Events of special interest include skin injury, arrhythmia, and priapism. The number and percentage of participants experiencing one or more adverse events will be summarized by study arm.","From informed consent through Month 6 after the end of treatment",null,{"allocation":145,"interventionModel":146,"interventionModelDescription":143,"primaryPurpose":147,"observationalModel":143,"timePerspective":143,"maskingInfo":148},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":149,"maskingDescription":143,"whoMasked":150},"SINGLE",[151],"PARTICIPANT","This is a two-center, participant-masked, randomized, sham-controlled clinical trial designed to evaluate the efficacy and safety of enhanced external counterpulsation (EECP) in older men with hypertension and erectile dysfunction.\n\nHypertension and erectile dysfunction may share vascular endothelial dysfunction as an underlying pathophysiological mechanism. EECP is a noninvasive external counterpulsation treatment that may improve systemic blood flow, tissue perfusion, and vascular endothelial function. This study will primarily evaluate the effect of EECP on blood pressure and will also explore its effects on erectile function and vascular function.\n\nA total of 106 male participants aged 60 to 75 years will be enrolled. Eligible participants must have hypertension and erectile dysfunction, defined as a 5-item International Index of Erectile Function (IIEF-5) score of 21 or lower with a duration of at least 3 months.\n\nParticipants will be randomly assigned in a 1:1 ratio to the active EECP group or the sham EECP group. Stratified block randomization will be used, with study center as the stratification factor and a block size of 4. Participants will be masked to treatment assignment. Both groups will continue their usual antihypertensive treatment, and antihypertensive medication regimens will be kept stable whenever clinically feasible during the study.\n\nParticipants assigned to the active EECP group will receive electrocardiogram-triggered sequential cuff inflation at a pressure of 250 to 275 mmHg. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks.\n\nParticipants assigned to the sham EECP group will undergo the same treatment procedures using the same device and treatment schedule, but the cuff pressure will be set at 70 mmHg. This pressure is intended to preserve a treatment experience similar to active EECP without producing effective counterpulsation.\n\nThe primary objective is to compare the change from baseline to the end of the treatment period in average office blood pressure between the active EECP and sham EECP groups. Average office blood pressure will be calculated from three consecutive blood pressure measurements obtained at the study visit.\n\nSecondary and exploratory assessments will include immediate changes in blood pressure and heart rate before, during, and after individual treatment sessions; changes in office blood pressure after 20 treatment sessions and during follow-up; and parameters obtained from 24-hour ambulatory blood pressure monitoring.\n\nErectile function will be assessed using the IIEF-5, Sexual Encounter Profile questions 2 and 3, the Global Assessment Question, the Self-Esteem and Relationship questionnaire, and the Erectile Hardness Score.\n\nOther assessments will include serum nitric oxide and vascular endothelial growth factor levels; vascular endothelial function; penile arterial blood-flow parameters; systemic hemodynamic parameters; pulse wave velocity; heart rate variability; psychological status; sleep quality; quality of life; and nocturia.\n\nSafety will be evaluated by recording the occurrence, severity, and relationship to treatment of adverse events, including skin injury, arrhythmia, and priapism.\n\nStudy assessments will be conducted at baseline, after 20 EECP sessions, at completion of treatment, and at 1, 3, and 6 months after treatment. The study hypothesis is that active EECP will produce a greater improvement in blood pressure than sham EECP and may also improve erectile function, potentially through beneficial effects on vascular endothelial function.",[154,160],{"label":155,"type":156,"description":157,"interventionNames":158},"Active EECP","EXPERIMENTAL","Participants will continue their usual antihypertensive treatment and receive active enhanced external counterpulsation (EECP). Active EECP will be delivered using an electrocardiogram-triggered EECP device with sequential cuff inflation at a pressure of 250 to 275 mmHg. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks.",[159],"Device: Enhanced External Counterpulsation",{"label":161,"type":162,"description":163,"interventionNames":164},"Sham EECP","SHAM_COMPARATOR","Participants will continue their usual antihypertensive treatment and receive sham enhanced external counterpulsation using the same device, cuff placement, procedures, and treatment schedule as the active intervention. The cuff pressure will be set at 70 mmHg, which is not expected to produce effective counterpulsation. Treatment will be administered for 1 hour per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks.",[165],"Device: Sham Enhanced External Counterpulsation",[167,175],{"type":168,"name":169,"description":170,"armGroupLabels":171,"otherNames":172},"DEVICE","Enhanced External Counterpulsation","Active enhanced external counterpulsation (EECP) will be delivered using an electrocardiogram-triggered EECP system (model P-ECP\u002FTI). Pneumatic cuffs placed around the calves, thighs, and buttocks will inflate sequentially during cardiac diastole and deflate before systole. The cuff pressure will be set at 250 to 275 mmHg. Treatment will be administered for 60 minutes per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. Participants will continue their usual antihypertensive treatment, which will be kept stable whenever clinically feasible during the study.",[155],[173,174],"EECP","P-ECP\u002FTI",{"type":168,"name":176,"description":177,"armGroupLabels":178,"otherNames":179},"Sham Enhanced External Counterpulsation","Sham enhanced external counterpulsation will be administered using the same EECP device, cuff placement, electrocardiogram triggering, procedures, session duration, frequency, and treatment period as active EECP. The cuff pressure will be set at 70 mmHg, which is intended to provide a treatment experience similar to active EECP without producing effective counterpulsation. Treatment will be administered for 60 minutes per session, once daily, 7 days per week, for a planned total of 35 sessions over 5 weeks. Participants will continue their usual antihypertensive treatment, which will be kept stable whenever clinically feasible during the study.",[161],[161],[181,186],{"name":182,"role":183,"phone":184,"phoneExt":143,"email":185},"Lin Shen, MD","CONTACT","+8618560082257","slmm321@126.com",{"name":187,"role":183,"phone":188,"phoneExt":143,"email":189},"Shihao Sun","+86-13853993929","sunshihao131@163.com",[191,209],{"facility":192,"status":143,"city":193,"state":194,"zip":195,"country":196,"countryCode":197,"cosmosGeoPoint":198,"geoPoint":203,"contacts":204},"The Seventh Affiliated Hospital (Shenzhen), Sun Yat-sen University","Shenzhen","Guangdong","518107","China","CN",{"type":199,"coordinates":200},"Point",[201,202],114.0683,22.54554,{"lat":202,"lon":201},[205],{"name":206,"role":183,"phone":207,"phoneExt":143,"email":208},"Xujun Xuan, MD","+86-18802006303","xxjun777@163.com",{"facility":5,"status":143,"city":210,"state":211,"zip":212,"country":196,"countryCode":197,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Jinan","Shandong","250000",{"type":199,"coordinates":214},[215,216],116.99722,36.66833,{"lat":216,"lon":215},[219,220],{"name":182,"role":183,"phone":184,"phoneExt":143,"email":185},{"name":187,"role":183,"phone":188,"phoneExt":143,"email":189},{"type":222,"investigatorFullName":143,"investigatorTitle":143,"investigatorAffiliation":143,"oldNameTitle":143,"oldOrganization":143},"SPONSOR","100656844","eecp-for-erectile-dysfunction-in-elderly-hypertensive-patients-100656844",false,"NCT07831551","EECP for Erectile Dysfunction in Elderly Hypertensive Patients","Efficacy and Safety of Enhanced External Counterpulsation in Elderly Hypertensive Patients With Erectile Dysfunction: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Male participants aged 60 to 75 years with a stable sexual partner.\n* Diagnosis of hypertension, defined as one of the following: office blood pressure ≥140\u002F90 mmHg measured on three separate days without antihypertensive treatment; mean home blood pressure ≥135\u002F85 mmHg measured over 5 to 7 consecutive days; or 24-hour ambulatory blood pressure ≥130\u002F80 mmHg, daytime blood pressure ≥135\u002F85 mmHg, or nighttime blood pressure ≥120\u002F70 mmHg. Participants with a previous diagnosis of hypertension who are currently receiving antihypertensive treatment remain eligible even if their current blood pressure is below these thresholds.\n* Diagnosis of erectile dysfunction, defined as a 5-item International Index of Erectile Function (IIEF-5) score ≤21 with a duration of at least 3 months.\n* Stable lifestyle, a stable female sexual partner, and willingness to attempt sexual intercourse with that partner during the study.\n* No treatment with phosphodiesterase type 5 inhibitors, hormones, health supplements, or other treatments intended to improve erectile function, including traditional Chinese medicines, within 3 months before enrollment.\n* Voluntary participation and ability to read, understand, and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe cardiac disease, including New York Heart Association class IV heart failure, left ventricular ejection fraction \\\u003C30%, malignant arrhythmia, or other clinically significant cardiac conditions.\n* Uncontrolled hypertension (\\>180\u002F110 mmHg) or secondary hypertension.\n* Diabetes mellitus.\n* Current use of other medications that may significantly affect blood pressure, such as glucocorticoids.\n* A condition associated with an increased risk of priapism, such as sickle cell anemia or leukemia.\n* Peptic ulcer disease, a bleeding disorder, visual abnormality, or hearing impairment.\n* Malignant tumor or another severe primary disease involving the heart, liver, kidneys, hematopoietic system, or another major organ or system.\n* Neurological or psychiatric disease that prevents cooperation with study procedures, or unwillingness to cooperate.\n* History of alcohol or drug abuse.\n* Participation in another clinical trial within the previous 3 months.\n* A contraindication to enhanced external counterpulsation, including severe aortic regurgitation, aortic aneurysm, active thrombophlebitis, or lower-extremity deep vein thrombosis.\n* A clinically significant penile anatomical or structural abnormality as determined by the investigator, including micropenis, penile curvature, or fibrosis of the corpora cavernosa.","MALE","60 Years","75 Years",{"count":234,"type":235},106,"ESTIMATED","INTERVENTIONAL",[238],"NA","Hypertension and erectile dysfunction are common health problems in older men and may share vascular dysfunction as an underlying mechanism. Enhanced external counterpulsation (EECP) is a noninvasive treatment in which inflatable cuffs placed around the legs and buttocks are inflated and deflated in synchronization with the heartbeat to improve blood flow.\n\nThe purpose of this randomized controlled trial is to determine whether EECP, when added to usual antihypertensive treatment, improves blood pressure and is safe in older men with both hypertension and erectile dysfunction. The study will also evaluate whether EECP improves erectile function and other measures related to vascular function, circulation, quality of life, sleep, and psychological well-being.\n\nA total of 106 men aged 60 to 75 years will be enrolled at two study centers. Participants will be randomly assigned in a 1:1 ratio to receive either active EECP or sham EECP in addition to their usual antihypertensive treatment. Active EECP will be administered for 1 hour per session, once daily, for 35 sessions over 5 weeks. Sham EECP will be administered using the same device and treatment schedule but at a low cuff pressure that is not expected to produce effective counterpulsation. Participants will not know which treatment they receive.\n\nThe main study outcome is the change from baseline to the end of the treatment period in average office blood pressure, calculated from three consecutive blood pressure measurements obtained at the study visit. Additional assessments will include office blood pressure during follow-up, 24-hour ambulatory blood pressure monitoring, erectile function, vascular function, hemodynamic measures, quality of life, and adverse events.\n\nParticipants will be assessed at baseline, after 20 treatment sessions, at the end of treatment, and at 1, 3, and 6 months after treatment.",[241,242],"Hypertension","Erectile Dysfunction",[169,173,244,245,246],"Ambulatory Blood Pressure Monitoring","Vascular Endothelial Function","Older Men","NOT_YET_RECRUITING","2026-09-16",{"date":250,"type":251},"2026-09-21","ACTUAL",{"date":253,"type":235},"2026-10-01",{"date":255,"type":235},"2027-10-01",{"name":5,"class":6},2]