Individualized Exercise Training in Hypertrophic Cardiomyopathy

NCT07835854 | Not Yet Recruiting

• 1 other identifier: 29820_1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Exercise intervention trials in patients with hypertrophic cardiomyopathy (HCM) have demonstrated an association with improvement in resting and exercise hemodynamics, ventricular remodeling, and anxiety/depression. 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.

Conditions

Hypertrophic Cardiomyopathy (HCM)

Keywords

Hypertrophic Cardiomyopathy; Exercise Intervention; Cardiac Myosin Inhibitor

Outcome Measures

Primary Outcomes (2)

• 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

• Ventilatory Efficiency (VE/VCO2 Slope)

  Ventilatory efficiency is defined as the slope of minute ventilation to carbon dioxide production (VE/VCO2) and will be evaluated via CPET performed at baseline and at 12-weeks. A lower slope indicates improved ventilatory efficiency.

  12 weeks

Secondary Outcomes (2)

• Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)

  12 weeks

• Short Form - 36 (SF-36)

  12 weeks

Study Arms (2)

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.

Behavioral: Exercise Intervention

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.

Behavioral: Physical Activity Handout

Interventions

Exercise Intervention BEHAVIORAL

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.

Intervention Arm

Physical Activity Handout BEHAVIORAL

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.

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years.
• Clinical diagnosis of HCM.
• Able to perform endurance and resistance exercise.
• Currently on stable dose of aficamten
• Not meeting current guideline recommended physical activity recommendations (150-300 minutes of moderate-vigorous physical activity/week, strength training ≥2 times weekly).
• Adequate clinical stability has been achieved (in the judgment of the investigator) to allow participation in study assessments and intervention.
• Signed informed consent indicating that the patient understands the purpose of the study, the procedures required and is willing to participate.

You may not qualify if:

• Residual left ventricular outflow tract obstruction (peak gradient ≥50mmHg at rest).
• Sustained ventricular arrhythmias or ICD shock within 6 months.
• Pregnancy.
• Severe valvular stenosis.
• Large pericardial effusion.
• Recent acute myocarditis (\< 3 months).
• Recent acute coronary syndrome or coronary artery bypass \< 6 months.
• Recent cardiac medication changes for management of cardiomyopathy.
• Patients with investigational intracardiac devices.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Related Publications (11)

• Landsteiner I, Masri A, Saberi S, Maron MS, McGinnis SL, Griskowitz C, Newlands CE, Barriales-Villa R, Owens AT, Lewis GD. Cardiopulmonary Exercise Testing for Characterization of Hypertrophic Cardiomyopathy: A Meta-Analysis. J Am Heart Assoc. 2025 Sep 2;14(17):e039551. doi: 10.1161/JAHA.124.039551. Epub 2025 Aug 29.

  PMID: 40878996 BACKGROUND

• Campain J, Griskowitz C, Newlands C, Claggett BL, Kulac IJ, McGinnis S, Giverts I, Moreno F, Minasian A, Prasad C, Rupert L, Landsteiner I, Iskenderian N, Coats CJ, Lee MMY, Maron MS, Owens AT, Jacoby DL, Heitner SB, Kupfer S, Malik FI, Wohltman A, Malhotra R, Lewis GD. Characterization and Application of Novel Exercise Recovery Patterns That Reflect Cardiac Performance: A Substudy of the SEQUOIA-HCM Trial. Circulation. 2025 Oct 7;152(14):990-1002. doi: 10.1161/CIRCULATIONAHA.124.073585. Epub 2025 Sep 5.

  PMID: 40910168 BACKGROUND

• Saberi S, Wheeler M, Bragg-Gresham J, Hornsby W, Agarwal PP, Attili A, Concannon M, Dries AM, Shmargad Y, Salisbury H, Kumar S, Herrera JJ, Myers J, Helms AS, Ashley EA, Day SM. Effect of Moderate-Intensity Exercise Training on Peak Oxygen Consumption in Patients With Hypertrophic Cardiomyopathy: A Randomized Clinical Trial. JAMA. 2017 Apr 4;317(13):1349-1357. doi: 10.1001/jama.2017.2503.

  PMID: 28306757 BACKGROUND

• MacNamara JP, Dias KA, Hearon CM Jr, Ivey E, Delgado VA, Saland S, Samels M, Hieda M, Turer AT, Link MS, Sarma S, Levine BD. Randomized Controlled Trial of Moderate- and High-Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy: Effects on Fitness and Cardiovascular Response to Exercise. J Am Heart Assoc. 2023 Oct 17;12(20):e031399. doi: 10.1161/JAHA.123.031399. Epub 2023 Oct 13.

  PMID: 37830338 BACKGROUND

• Basu J, Nikoletou D, Miles C, MacLachlan H, Parry-Williams G, Tilby-Jones F, Bulleros P, Fanton Z, Baker C, Purcell S, Lech C, Chapman T, Sage P, Wahid S, Sheikh N, Jayakumar S, Malhotra A, Keteepe-Arachi T, Gray B, Finocchiaro G, Carr-White G, Behr E, Tome M, O'Driscoll J, Chis Ster I, Sharma S, Papadakis M. High intensity exercise programme in patients with hypertrophic cardiomyopathy: a randomized trial. Eur Heart J. 2025 May 14;46(19):1803-1815. doi: 10.1093/eurheartj/ehae919.

  PMID: 40037382 BACKGROUND

• Coats CJ, Rantell K, Bartnik A, Patel A, Mist B, McKenna WJ, Elliott PM. Cardiopulmonary Exercise Testing and Prognosis in Hypertrophic Cardiomyopathy. Circ Heart Fail. 2015 Nov;8(6):1022-31. doi: 10.1161/CIRCHEARTFAILURE.114.002248. Epub 2015 Sep 15.

  PMID: 26374874 BACKGROUND

• Bayonas-Ruiz A, Munoz-Franco FM, Ferrer V, Perez-Caballero C, Sabater-Molina M, Tome-Esteban MT, Bonacasa B. Cardiopulmonary Exercise Test in Patients with Hypertrophic Cardiomyopathy: A Systematic Review and Meta-Analysis. J Clin Med. 2021 May 25;10(11):2312. doi: 10.3390/jcm10112312.

  PMID: 34070695 BACKGROUND

• Klempfner R, Kamerman T, Schwammenthal E, Nahshon A, Hay I, Goldenberg I, Dov F, Arad M. Efficacy of exercise training in symptomatic patients with hypertrophic cardiomyopathy: results of a structured exercise training program in a cardiac rehabilitation center. Eur J Prev Cardiol. 2015 Jan;22(1):13-9. doi: 10.1177/2047487313501277. Epub 2013 Aug 8.

  PMID: 23928567 BACKGROUND

• Finocchiaro G, Haddad F, Knowles JW, Caleshu C, Pavlovic A, Homburger J, Shmargad Y, Sinagra G, Magavern E, Wong M, Perez M, Schnittger I, Myers J, Froelicher V, Ashley EA. Cardiopulmonary responses and prognosis in hypertrophic cardiomyopathy: a potential role for comprehensive noninvasive hemodynamic assessment. JACC Heart Fail. 2015 May;3(5):408-418. doi: 10.1016/j.jchf.2014.11.011. Epub 2015 Apr 8.

  PMID: 25863972 BACKGROUND

• Kokkinos P, Faselis C, Samuel IBH, Pittaras A, Doumas M, Murphy R, Heimall MS, Sui X, Zhang J, Myers J. Cardiorespiratory Fitness and Mortality Risk Across the Spectra of Age, Race, and Sex. J Am Coll Cardiol. 2022 Aug 9;80(6):598-609. doi: 10.1016/j.jacc.2022.05.031.

  PMID: 35926933 BACKGROUND

• Ross R, Blair SN, Arena R, Church TS, Despres JP, Franklin BA, Haskell WL, Kaminsky LA, Levine BD, Lavie CJ, Myers J, Niebauer J, Sallis R, Sawada SS, Sui X, Wisloff U; American Heart Association Physical Activity Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Cardiovascular and Stroke Nursing; Council on Functional Genomics and Translational Biology; Stroke Council. Importance of Assessing Cardiorespiratory Fitness in Clinical Practice: A Case for Fitness as a Clinical Vital Sign: A Scientific Statement From the American Heart Association. Circulation. 2016 Dec 13;134(24):e653-e699. doi: 10.1161/CIR.0000000000000461. Epub 2016 Nov 21.

  PMID: 27881567 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Bradley J Petek, MD

CONTACT

503-494-6813; petek@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL