protocolSection identificationModule nctId: NCT06332391, orgStudyIdInfo id: 202308349, secondaryIdInfos id: R01HL168752, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL168752, briefTitle: Paced Heart Rate Acceleration for Cardiac Conditioning, acronym: HeartExcel, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2028-11-30, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Denice Hodgson-Zingman, MD, class: OTHER, collaborators name: The Cleveland Clinic, collaborators name: National Institutes of Health (NIH), collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule 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., conditionsModule conditions: Heart Failure, Systolic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, single blinded, randomized, controlled trial. Randomization to intervention versus sham groups in a 1:1 ratio., primaryPurpose: TREATMENT, maskingInfo 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, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Exercise-similar cardiac pacing, interventions name: Sham cardiac pacing, outcomesModule primaryOutcomes measure: Change in left ventricular ejection fraction by echocardiogram, secondaryOutcomes measure: Quality of Life score on the Minnesota Living with Heart Failure questionnaire, secondaryOutcomes measure: Quality of Life score on the Kansas City Cardiomyopathy Questionnaire, secondaryOutcomes measure: 6-minute walk distance, secondaryOutcomes measure: Cardiopulmonary exercise test maximum oxygen consumption, secondaryOutcomes measure: Cardiopulmonary exercise test metabolic equivalents achieved, secondaryOutcomes measure: Cardiopulmonary exercise test peak power output achieved, secondaryOutcomes measure: Cardiopulmonary exercise test total exercise time, secondaryOutcomes measure: daily minutes of sedentary activity, secondaryOutcomes measure: daily minutes of low activity, secondaryOutcomes measure: daily minutes of moderate activity, secondaryOutcomes measure: daily minutes of vigorous activity, secondaryOutcomes measure: major adverse cardiac events, secondaryOutcomes measure: symptom score during the intervention/sham procedure, secondaryOutcomes measure: maximum achieved pacing rate during the intervention/sham procedure, secondaryOutcomes measure: presence of significant arrhythmia during the intervention/sham procedure, secondaryOutcomes measure: vital signs - systolic blood pressure during the intervention/sham procedure, secondaryOutcomes measure: vital signs - oxygen saturation in the blood during the intervention/sham procedure, secondaryOutcomes measure: tolerability - vital signs - cardiac output, secondaryOutcomes measure: vital signs - cardiac output during the intervention/sham procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False