Hypertrophic Cardiomyopathy (HCM)GET-FIT HCMNCT07835854
Individualized Exercise Training in Hypertrophic Cardiomyopathy
A study testing Exercise Intervention and Physical Activity Handout in people with Hypertrophic Cardiomyopathy (HCM), run by Oregon Health and Science University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM)
- What is being tested?
- Exercise Intervention and Physical Activity Handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- Recent acute coronary syndrome or coronary artery bypass < 6 months.
- Recent cardiac medication changes for management of cardiomyopathy.
- Patients with investigational intracardiac devices.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Graded Exercise Training For Individualized Treatment in Hypertrophic Cardiomyopathy: GET-FIT Hypertrophic Cardiomyopathy Study
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.
Read the detailed description
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.
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Being tested
- Exercise Intervention, Physical Activity Handout
- Keywords
- Hypertrophic Cardiomyopathy, Exercise Intervention, Cardiac Myosin Inhibitor
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
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.
Physical Activity HandoutBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Physical Activity Handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Petek, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835854
- Sponsor's protocol ID
- 29820_1
- Acronym
- GET-FIT HCM
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A limited access dataset generated from this project will rapidly be made available to the broader community for distribution to outside researchers according to established Oregon Health \& Science University policies. Exercise training plans developed as part of the study will be made available.
Publications
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.
PubMed 40878996Campain 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.
PubMed 40910168Saberi 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.
PubMed 28306757MacNamara 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.
PubMed 37830338Basu 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.
PubMed 40037382Coats 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.
PubMed 26374874Bayonas-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.
PubMed 34070695Klempfner 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.
PubMed 23928567Finocchiaro 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.
PubMed 25863972Kokkinos 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.
PubMed 35926933Ross 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.
PubMed 27881567
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graded Exercise Training For Individualized Treatment in Hypertrophic Cardiomyopathy: GET-FIT Hypertrophic Cardiomyopathy Study
- ClinicalTrials.gov ID
- NCT07835854
- Acronym / sponsor ID
- GET-FIT HCM / 29820_1
- Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Keywords
- Hypertrophic Cardiomyopathy, Exercise Intervention, Cardiac Myosin Inhibitor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Exercise InterventionParticipants 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. |
| Control Arm | Active comparator | Behavioral: Physical Activity HandoutParticipants randomized to the control arm will be receive a Physical Activity Recommendations Handout and a smartwatch to track physical activity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionA 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. | Behavioural | Intervention Arm |
| Physical Activity HandoutAn 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. | Behavioural | Control Arm |
Primary outcome
Peak oxygen consumption (Peak VO2)
Time frame: 12 weeks
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.
Ventilatory Efficiency (VE/VCO2 Slope)
Time frame: 12 weeks
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.
2 secondary outcomes
Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)
Time frame: 12 weeks
Short Form - 36 (SF-36)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 40878996Landsteiner 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.
- Background: PubMed 40910168Campain 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.
- Background: PubMed 28306757Saberi 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.
- Background: PubMed 37830338MacNamara 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.
- Background: PubMed 40037382Basu 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.
- Background: PubMed 26374874Coats 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.
- Background: PubMed 34070695Bayonas-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.
- Background: PubMed 23928567Klempfner 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.
- Background: PubMed 25863972Finocchiaro 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.
- Background: PubMed 35926933Kokkinos 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.
- Background: PubMed 27881567Ross 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.
- Individual participant dataSharing planned: Yes. A limited access dataset generated from this project will rapidly be made available to the broader community for distribution to outside researchers according to established Oregon Health \& Science University policies. Exercise training plans developed as part of the study will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention and Physical Activity Handout in people with Hypertrophic Cardiomyopathy (HCM), run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bradley J Petek, MD (503-494-6813, petek@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (Peak VO2) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07835854, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.