[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657207":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":32,"studyPopulation":23,"armGroups":33,"interventions":46,"overallOfficials":23,"centralContacts":56,"locations":23,"responsibleParty":62,"collaborators":23,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":23,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":89,"whyStopped":23,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":23},{"fullName":5,"class":6},"Oregon Health and Science University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Peak oxygen consumption (Peak VO2)","CPET performed at baseline and 12-weeks, following the exercise intervention will be used to measure aerobic capacity, peak VO2. The change in peak VO2 from baseline to 12 weeks is the primary outcome measure.","12 weeks",{"measure":14,"description":15,"timeFrame":12},"Ventilatory Efficiency (VE\u002FVCO2 Slope)","Ventilatory efficiency is defined as the slope of minute ventilation to carbon dioxide production (VE\u002FVCO2) and will be evaluated via CPET performed at baseline and at 12-weeks. A lower slope indicates improved ventilatory efficiency.",[17,20],{"measure":18,"description":19,"timeFrame":12},"Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)","Quality of life questionnaire scaled from 0 to 100, where higher scores indicate better health status. This will be recorded at baseline and 12-weeks. An increase of 5 points is considered a clinically meaningful increase.",{"measure":21,"description":22,"timeFrame":12},"Short Form - 36 (SF-36)","The SF-36 is a general health survey to assess overall physical and mental health domains. Scores on each scale range from 0 to 100, with higher scores representing better health-related quality of life and higher overall functional capacity.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":30},"SINGLE",[31],"INVESTIGATOR","Habitual exercise has been shown to improve longevity and reduce mortality. Patients with HCM often have reduced exercise tolerance as the disease progresses. Cardiopulmonary exercise testing (CPET) is often performed to assess quantitative exercise capacity in clinical testing, but questions remain on normative values and how to accurately predict prognosis in individuals with HCM. Peak oxygen consumption (peak VO2) measured by CPET is the gold standard for assessing cardiorespiratory fitness and is an important prognostic marker in cardiovascular health. Prior RCTs have demonstrated that 12 to 20 weeks of exercise training can safely improve peak VO2, hemodynamics, and quality of life in selected patients with HCM. However, existing exercise trials have not included individuals actively treated with CMIs, which represent an emerging standard of care. Further, these exercise intervention trials have not universally included resistance training, despite recommendations in current guidelines. This study aims to evaluate whether an individualized exercise regimen combining endurance and resistance training provides additive improvements in exercise capacity and quality of life for HCM patients on aficamten.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"Intervention Arm","EXPERIMENTAL","Participants randomized to the intervention arm will be prescribed a training plan and provided with a gym membership including personal training sessions. Participants will also be given a smartwatch and chest strap to track physical activity.",[39],"Behavioral: Exercise Intervention",{"label":41,"type":42,"description":43,"interventionNames":44},"Control Arm","ACTIVE_COMPARATOR","Participants randomized to the control arm will be receive a Physical Activity Recommendations Handout and a smartwatch to track physical activity.",[45],"Behavioral: Physical Activity Handout",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":23},"BEHAVIORAL","Exercise Intervention","A 3-month training plan with a gym membership including weekly personal training sessions. Subjects will also be given a Garmin Forerunner 55 smartwatch and Garmin HRM 200 chest strap to track heart rates during exercise.",[35],{"type":48,"name":53,"description":54,"armGroupLabels":55,"otherNames":23},"Physical Activity Handout","An American Heart Association Physical Activity Recommendations handout will be provided, and a Garmin Forerunner 55 smartwatch will be given to subjects to wear during waking hours over 3-month period.",[41],[57],{"name":58,"role":59,"phone":60,"phoneExt":23,"email":61},"Bradley J Petek, MD","CONTACT","503-494-6813","petek@ohsu.edu",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Bradley Petek","Principal Investigator","100657207","individualized-exercise-training-in-hypertrophic-cardiomyopathy-100657207",false,"NCT07835854","Individualized Exercise Training in Hypertrophic Cardiomyopathy","Graded Exercise Training For Individualized Treatment in Hypertrophic Cardiomyopathy: GET-FIT Hypertrophic Cardiomyopathy Study","GET-FIT HCM","Inclusion Criteria:\n\n* Age 18-80 years.\n* Clinical diagnosis of HCM.\n* Able to perform endurance and resistance exercise.\n* Currently on stable dose of aficamten\n* Not meeting current guideline recommended physical activity recommendations (150-300 minutes of moderate-vigorous physical activity\u002Fweek, strength training ≥2 times weekly).\n* Adequate clinical stability has been achieved (in the judgment of the investigator) to allow participation in study assessments and intervention.\n* Signed informed consent indicating that the patient understands the purpose of the study, the procedures required and is willing to participate.\n\nExclusion Criteria:\n\n* Residual left ventricular outflow tract obstruction (peak gradient ≥50mmHg at rest).\n* Sustained ventricular arrhythmias or ICD shock within 6 months.\n* Pregnancy.\n* Severe valvular stenosis.\n* Large pericardial effusion.\n* Recent acute myocarditis (\\\u003C 3 months).\n* Recent acute coronary syndrome or coronary artery bypass \\\u003C 6 months.\n* Recent cardiac medication changes for management of cardiomyopathy.\n* Patients with investigational intracardiac devices.","ALL","18 Years","80 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","Exercise intervention trials in patients with hypertrophic cardiomyopathy (HCM) have demonstrated an association with improvement in resting and exercise hemodynamics, ventricular remodeling, and anxiety\u002Fdepression. However, no randomized controlled trials (RCTs) to date have assessed the effects of exercise intervention in patients with HCM on cardiac myosin inhibitors (CMIs). This trial aims to evaluate the efficacy of a 12-week individualized exercise training program in HCM patients receiving aficamten.",[85],"Hypertrophic Cardiomyopathy (HCM)",[87,49,88],"Hypertrophic Cardiomyopathy","Cardiac Myosin Inhibitor","NOT_YET_RECRUITING","2026-09-17",{"date":92,"type":93},"2026-09-23","ACTUAL",{"date":95,"type":79},"2026-09-15",{"date":97,"type":79},"2028-09-30",{"name":5,"class":6}]