EECP for Erectile Dysfunction in Elderly Hypertensive Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age60-75
SponsorQilu Hospital of Shandong University
About this trial
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.
The 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.
A 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.
The 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.
Participants will be assessed at baseline, after 20 treatment sessions, at the end of treatment, and at 1, 3, and 6 months after treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male participants aged 60 to 75 years with a stable sexual partner.
Diagnosis of hypertension, defined as one of the following: office blood pressure ≥140/90 mmHg measured on three separate days without antihypertensive treatment; mean home blood pressure ≥135/85 mmHg measured over 5 to 7 consecutive days; or 24-hour ambulatory blood pressure ≥130/80 mmHg, daytime blood pressure ≥135/85 mmHg, or nighttime blood pressure ≥120/70 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.
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.
Stable lifestyle, a stable female sexual partner, and willingness to attempt sexual intercourse with that partner during the study.
Disqualifiers
Severe cardiac disease, including New York Heart Association class IV heart failure, left ventricular ejection fraction <30%, malignant arrhythmia, or other clinically significant cardiac conditions.
Uncontrolled hypertension (>180/110 mmHg) or secondary hypertension.
Diabetes mellitus.
Current use of other medications that may significantly affect blood pressure, such as glucocorticoids.
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced External Counterpulsation
DeviceActive enhanced external counterpulsation (EECP) will be delivered using an electrocardiogram-triggered EECP system (model P-ECP/TI). 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.
Sham Enhanced External Counterpulsation
DeviceSham 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.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Active EECPExperimental treatment 1 intervention
Group B: Sham EECPSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and Day 35 (end of the 5-week treatment period)Secondary outcomes
1
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.
Time frame
Baseline and Week 5 (end of the treatment period)2
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.
Time frame
At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment3
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.
Time frame
At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatment4
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.
Time frame
At each treatment session from Day 1 through Week 5: 3 minutes before treatment, 30 minutes after treatment initiation, and 3 minutes after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: