nctId: NCT06332391 id: 202308349 id: R01HL168752 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL168752 briefTitle: Paced Heart Rate Acceleration for Cardiac Conditioning acronym: HeartExcel overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-06-30 date: 2028-11-30 date: 2024-03-27 date: 2024-03-27 name: Denice Hodgson-Zingman, MD class: OTHER name: The Cleveland Clinic name: National Institutes of Health (NIH) name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed severe left ventricular dysfunction due to ischemic or non-ischemic cardiomyopathy and an existing implantable cardioverter defibrillator or biventricular implantable cardioverter defibrillator. The purpose of the study is to understand how the heart rate pattern of exercise contributes to the considerable cardiac conditioning effects of exercise and estimate whether the pacing approach may have translational clinical applicability. Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks. Baseline symptoms and clinical test results will be compared to the same measures at 2 weeks, 4 weeks and 6 weeks of intervention/sham and at 3 months and one-year post-intervention. The primary endpoint will be the change in left ventricular ejection fraction from baseline in intervention vs. sham groups (mixed effects linear regression with time and treatment arm as fixed effects and pre-specified covariates of sex and cardiomyopathy type as random effects). Secondary endpoints will include changes in quality of life, 6-minute walk distance, cardiopulmonary exercise test (CPET) measures, daily activity and major adverse cardiac events (MACE) at 3 and 12 months between pacing and sham groups. A "dose-response" analysis of outcomes at 2, 4, and 6 weeks of the intervention vs. sham compared with baseline will be performed. conditions: Heart Failure, Systolic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, single blinded, randomized, controlled trial. Randomization to intervention versus sham groups in a 1:1 ratio. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Subjects and outcomes assessors are blinded to study group (intervention vs. sham) but investigator is not. During intervention vs. sham, subjects do not have access to vital sign data and sham procedures follow intervention procedures exactly with the exception that no change in pacing rate is delivered. A blinding questionnaire is given to subjects to assess adequacy of blinding. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: Exercise-similar cardiac pacing name: Sham cardiac pacing measure: Change in left ventricular ejection fraction by echocardiogram measure: Quality of Life score on the Minnesota Living with Heart Failure questionnaire measure: Quality of Life score on the Kansas City Cardiomyopathy Questionnaire measure: 6-minute walk distance measure: Cardiopulmonary exercise test maximum oxygen consumption measure: Cardiopulmonary exercise test metabolic equivalents achieved measure: Cardiopulmonary exercise test peak power output achieved measure: Cardiopulmonary exercise test total exercise time measure: daily minutes of sedentary activity measure: daily minutes of low activity measure: daily minutes of moderate activity measure: daily minutes of vigorous activity measure: major adverse cardiac events measure: symptom score during the intervention/sham procedure measure: maximum achieved pacing rate during the intervention/sham procedure measure: presence of significant arrhythmia during the intervention/sham procedure measure: vital signs - systolic blood pressure during the intervention/sham procedure measure: vital signs - oxygen saturation in the blood during the intervention/sham procedure measure: tolerability - vital signs - cardiac output measure: vital signs - cardiac output during the intervention/sham procedure sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False