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Cardiomyopathy, HypertrophicMavaEnExNCT07077005

Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy

A study testing Exercise training in people with Cardiomyopathy, Hypertrophic, run by Technical University of Munich at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Patients with hypertrophic obstructive cardiomyopathy and New York Heart Association Class I-II under stable treatment with mavacamten (at least 12 weeks without change of dosage) and a peak left ventricular outflow tract obstruction <50mmHg undergo either 6 weeks of structured moderate intensity endurance and… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Cardiomyopathy, Hypertrophic
What is being tested?
Exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteGermany
Study dates
1 Nov 2025to 31 Jan 2027
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 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years of age
  • Diagnosis of hypertrophic obstructive cardiomyopathy
  • ≥12 weeks of unchanged dosage of mavacamten
  • Peak left ventricular outflow tract gradient ≤ 50 mmHg at rest and during stress echocardiography
  • Left ventricular ejection fraction ≥50% at study inclusion
  • New York Heart Association classes I-II

Who cannot join

  • Syncope or sustained ventricular tachycardia within 6 months prior to study inclusion
  • Corrected QT-interval (Fridericia-formula) ≥ 500 ms
  • Paroxysmal or intermittent atrial fibrillation (AF) on screening electrocardiogram
  • Persistent or permanent AF without anticoagulation for ≥4 weeks
  • Previous transcoronary ablation of septal hypertrophy or surgical myectomy
  • Ventricular tachycardia, significant ST-elevation or depression upon baseline cardiopulmonary exercise testing
Show all 9Show fewer
  • ≥ grade II valve insufficiencies or stenoses during resting echocardiography
  • Prior implantable cardioverter defibrillator-implantation
  • Sudden Cardiac Death Risk Score ≥4%

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Simon Wernhart, MD contact

00498941406774

simon.wernhart@mri.tum.de

Martin Halle, Professor contact

00498941406774

martin.halle@mri.tum.de

Germany1 site, 1 recruiting

  • Technical University Munich

    Munich, Bavaria, 81675

    Simon Wernhart, MD, 004941406774, simon.wernhart@mri.tum.de

    Martin Halle, Professor, 00498941406774, martin.halle@mri.tum.de

    Recruiting

Other trials in Germany

About this study

Official title: MavaEnEx-HOCM: Mavacamten Enables Exercise Training in Patients With Hypertrophic Obstructive CardioMyopathy. A Pilot Study

Patients with hypertrophic obstructive cardiomyopathy and New York Heart Association Class I-II under stable treatment with mavacamten (at least 12 weeks without change of dosage) and a peak left ventricular outflow tract obstruction <50mmHg undergo either 6 weeks of structured moderate intensity endurance and resistance training (supervised, 3x/week, intervention, IT) or usual care (UC). Patients within 1 hour of travel to the training venue will be referred to IT, while those with more than 1 hour will join UC.

At baseline (visit 1, V1) and after 6 weeks of exercise intervention (visit 2, V2) all patients undergo a medical exam, resting and stress echocardiography and receive a questionnaire on the quality of life (Kansas City Cardiomyopathy Questionnaire). Cardiac biomarkers are assessed. 3 hours after stress echocardiography cardiopulmonary exercise testing is performed to measure peak oxygen consumption (VO2peak).

The primary outcome is safety. Secondary outcomes include the change of VO2peak, changes in cardiac biomarkers, resting and stress echocardiographic variables, quality of life and variables of cardiopulmonary exercise testing from V1 to V2.

Read the detailed description

Patients with hypertrophic obstructive cardiomyopathy and New York Heart Association Class I-II under stable treatment with mavacamten (at least 12 weeks without change of dosage) and a peak left ventricular outflow tract obstruction <50mmHg at rest and during peak exercise undergo either 6 weeks of structured moderate intensity endurance and resistance training (supervised, 3x/week, intervention group, IT) or usual care (UC). UC will receive standard recommendations on physical activity but no supervised training. All patients receive smart watches and electrocardiograms can be triggered upon symptoms.

Patients previously treated with transcoronary septal ablation or surgical myectomy, more than low grade valve pathology during resting echocardiography, syncope or sustained ventricular tachycardia within 6 months prior to study inclusion, prior implantable cardioverter defibrillator implantation, persistent or permanent atrial fibrillation (AF) without anticoagulation for ≥4 weeks or paroxysmal or intermittent AF on screening electrocardiogram, or a corrected QT-interval (Fridericia-formula) ≥ 500 ms will be excluded. Patients with a Sudden Cardiac Death Risk Score ≥4% are excluded from the study.

Due to the rare nature of the disease and the large geographical variation, patients within 1 hour of travel to the training site will join IT, patients travelling more than 1 hour will be grouped into UC.

At baseline (visit 1, V1) and after 6 weeks of exercise intervention (visit 2, V2) all patients undergo a medical exam, resting and stress echocardiography and receive a questionnaire on the quality of life (Kansas City Cardiomyopathy Questionnaire). Cardiac biomarkers are assessed. 3 hours after stress echocardiography cardiopulmonary exercise testing (CPET) is performed to measure peak oxygen consumption (VO2peak).

The primary outcome is safety (no ventricular arrhythmias during exercise intervention or within 1 hour after completion of exercise). Secondary outcomes include changes in VO2peak, changes in cardiac biomarkers, resting and stress echocardiographic variables, quality of life and CPET variables. Physicians performing the echocardiographies and CPET analyses will be blinded to group allocation.

Being tested
Exercise training
Keywords
exercise capacity, mavacamten, safety, exercise training
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07077005
Study groupRoleWhat they receive
ExerciseExperimentalSupervised combined endurance and resistance training on top of mavacamten therapy
Receives: Other: Exercise training
Usual CareNo interventionNo supervised exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events

    Safety is defined by the abscence of adverse or serious adverse events during exercise training or within 1h of exercise termination. Adverse events include non-sustained ventricular tachycardia (nsVT) and atrial fibrillation. Serious adverse events contain hospitalization due to cardiovascular events, sustained ventricular tachycardia, nsVT with hemodynamic compromise, syncope, cardiac arrest and sudden cardiac death. Higher scores mean a worse outcome.

    Measured: 6 weeks

Secondary outcomes (7)

  1. Change of resting left ventricular ejection fraction

    Changes of resting left ventricular ejection fraction between visit 1 and visit 2 between the exercise and usual care group.

    Measured: 6 weeks

  2. Change of tissue Doppler velocity during peak exercise

    Changes of tissue Doppler velocity (average between medial and lateral velocities) during peak exercise between visit 1 and visit 2 between the exercise and usual care group. Higher scores mean a better diastolic function.

    Measured: 6 weeks

  3. Change of minute ventilation to carbon dioxide production

    Changes of minute ventilation to carbon dioxide production between visit 1 and visit 2 between the exercise and usual care group. Higher scores mean a worse outcome.

    Measured: 6 weeks

  4. Change of Kansas City Cardiomyopathy Score

    Changes of quality of life between visit 1 and visit 2 between the exercise and usual care group. Quality of life is assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ), a difference of at least five points is considered significant. KCCQ ranges from 0 to 100 points, while 0 means worst quality of life, 100 being best quality of life.

    Measured: 6 weeks

  5. Change of N-terminal pro-B-type natriuretic peptide and troponin I

    Changes of cardiac biomarkers N-terminal pro-B-type natriuretic peptide (NTproBNP, pg/ml) and troponin I (pg/ml) between visit 1 and visit 2 between the exercise and usual care group. Higher scores mean a worse outcome.

    Measured: 6 weeks

  6. Differences of incidence of atrial fibrillation, atrial or ventricular tachycardia on electrocardiograms

    Between group differences of incidence of atrial fibrillation, atrial tachycardia or ventricular tachycardia on electrocardiograms triggered by the smart watch electrocardiograms or displayed by electrocardiograms during visits.

    Measured: 6 weeks

  7. Change of peak oxygen consumption

    Changes of peak oxygen consumption between visit 1 and visit 2 between the exercise and usual care group. A change of 1.5mL/kg/min is considered significant. Higher scores mean a better outcome.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start1 Nov 2025
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be allocated to an exercise intervention group undergoing combined endurance and resistance training for 6 weeks or to a usual care group.
Masking
Single blind
Who is masked
Investigator
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07077005
Sponsor's protocol ID
2025-125-S-SB
Acronym
MavaEnEx
Status last verified
Dec 2025
First submitted
10 Jul 2025
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be made available on reasonable request to the principal investigator

Publications

  • Sachdev V, Sharma K, Keteyian SJ, Alcain CF, Desvigne-Nickens P, Fleg JL, Florea VG, Franklin BA, Guglin M, Halle M, Leifer ES, Panjrath G, Tinsley EA, Wong RP, Kitzman DW; American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology; Council on Arteriosclerosis, Thrombosis and Vascular Biology; and American College of Cardiology. Supervised Exercise Training for Chronic Heart Failure With Preserved Ejection Fraction: A Scientific Statement From the American Heart Association and American College of Cardiology. Circulation. 2023 Apr 18;147(16):e699-e715. doi: 10.1161/CIR.0000000000001122. Epub 2023 Mar 21.

    PubMed 36943925

  • Ommen SR, Ho CY, Asif IM, Balaji S, Burke MA, Day SM, Dearani JA, Epps KC, Evanovich L, Ferrari VA, Joglar JA, Khan SS, Kim JJ, Kittleson MM, Krittanawong C, Martinez MW, Mital S, Naidu SS, Saberi S, Semsarian C, Times S, Waldman CB; Peer Review Committee Members. 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR Guideline for the Management of Hypertrophic Cardiomyopathy: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jun 4;149(23):e1239-e1311. doi: 10.1161/CIR.0000000000001250. Epub 2024 May 8.

    PubMed 38718139

  • Bertero E, Canepa M, Olivotto I. Hypertrophic cardiomyopathy evolving management: American Heart Association/American College of Cardiology vs. European Society of Cardiology guidelines. Eur Heart J. 2025 Jan 21;46(4):359-361. doi: 10.1093/eurheartj/ehae507. No abstract available.

    PubMed 39504436

  • Arbelo E, Protonotarios A, Gimeno JR, Arbustini E, Barriales-Villa R, Basso C, Bezzina CR, Biagini E, Blom NA, de Boer RA, De Winter T, Elliott PM, Flather M, Garcia-Pavia P, Haugaa KH, Ingles J, Jurcut RO, Klaassen S, Limongelli G, Loeys B, Mogensen J, Olivotto I, Pantazis A, Sharma S, Van Tintelen JP, Ware JS, Kaski JP; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023 Oct 1;44(37):3503-3626. doi: 10.1093/eurheartj/ehad194. No abstract available.

    PubMed 37622657

  • Kim JH, Baggish AL, Levine BD, Ackerman MJ, Day SM, Dineen EH, Guseh Ii JS, La Gerche A, Lampert R, Martinez MW, Papadakis M, Phelan DM, Shafer KM; American Heart Association Leadership Committee of the Council on Clinical Cardiology; Council on Basic Cardiovascular Sciences; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Surgery and Anesthesia; Council on Peripheral Vascular Disease; American College of Cardiology; Allen LA, Borjesson M, Braverman AC, Brothers JA, Castelletti S, Chung EH, Churchill TW, Claessen G, D'Ascenzi F, Darden D, Dean PN, Dickert NW, Drezner JA, Economy KE, Eijsvogels TMH, Emery MS, Etheridge SP, Gati S, Gray B, Halle M, Harmon KG, Hsu JJ, Kovacs RJ, Krishnan S, Link MS, Maron M, Molossi S, Pelliccia A, Salerno JC, Shah AB, Sharma S, Singh TK, Stewart KM, Thompson PD, Wasfy MM, Wilhelm M. Clinical Considerations for Competitive Sports Participation for Athletes With Cardiovascular Abnormalities: A Scientific Statement From the American Heart Association and American College of Cardiology. J Am Coll Cardiol. 2025 Mar 18;85(10):1059-1108. doi: 10.1016/j.jacc.2024.12.025. Epub 2025 Feb 20.

    PubMed 39976316

  • 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.

    PubMed 40037382

  • Olivotto I, D'Ascenzi F. Exercise prescription in hypertrophic cardiomyopathy: Dr Lown's lesson to break taboos. Eur Heart J. 2025 May 14;46(19):1816-1818. doi: 10.1093/eurheartj/ehae659. No abstract available.

    PubMed 40037289

  • Olivotto I, Oreziak A, Barriales-Villa R, Abraham TP, Masri A, Garcia-Pavia P, Saberi S, Lakdawala NK, Wheeler MT, Owens A, Kubanek M, Wojakowski W, Jensen MK, Gimeno-Blanes J, Afshar K, Myers J, Hegde SM, Solomon SD, Sehnert AJ, Zhang D, Li W, Bhattacharya M, Edelberg JM, Waldman CB, Lester SJ, Wang A, Ho CY, Jacoby D; EXPLORER-HCM study investigators. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020 Sep 12;396(10253):759-769. doi: 10.1016/S0140-6736(20)31792-X. Epub 2020 Aug 29.

    PubMed 32871100

  • Wheeler MT, Olivotto I, Elliott PM, Saberi S, Owens AT, Maurer MS, Masri A, Sehnert AJ, Edelberg JM, Chen YM, Florea V, Malhotra R, Wang A, Oreziak A, Myers J. Effects of Mavacamten on Measures of Cardiopulmonary Exercise Testing Beyond Peak Oxygen Consumption: A Secondary Analysis of the EXPLORER-HCM Randomized Trial. JAMA Cardiol. 2023 Mar 1;8(3):240-247. doi: 10.1001/jamacardio.2022.5099.

    PubMed 36652223

  • Lampert R, Ackerman MJ, Marino BS, Burg M, Ainsworth B, Salberg L, Tome Esteban MT, Ho CY, Abraham R, Balaji S, Barth C, Berul CI, Bos M, Cannom D, Choudhury L, Concannon M, Cooper R, Czosek RJ, Dubin AM, Dziura J, Eidem B, Emery MS, Estes NAM, Etheridge SP, Geske JB, Gray B, Hall K, Harmon KG, James CA, Lal AK, Law IH, Li F, Link MS, McKenna WJ, Molossi S, Olshansky B, Ommen SR, Saarel EV, Saberi S, Simone L, Tomaselli G, Ware JS, Zipes DP, Day SM; LIVE Consortium. Vigorous Exercise in Patients With Hypertrophic Cardiomyopathy. JAMA Cardiol. 2023 Jun 1;8(6):595-605. doi: 10.1001/jamacardio.2023.1042.

    PubMed 37195701

  • Maron BJ, Rowin EJ, Bonaventura J, Basso C, Corrado D, Thiene G, Churchwell AL, Basilico F, Thompson PD, Nishimura RA, Estes NAM. Commentary: Sudden death in competitive student-athletes with hypertrophic cardiomyopathy at a crossroads: Critical views on liberalizing return-to-play eligibility. Heart Rhythm. 2026 Mar;23(3):688-695. doi: 10.1016/j.hrthm.2025.06.014. Epub 2025 Jun 19. No abstract available.

    PubMed 40543859

  • Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available.

    PubMed 32860412

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training in people with Cardiomyopathy, Hypertrophic, run by Technical University of Munich at 1 site in Germany.

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 6 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: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Simon Wernhart, MD (00498941406774, simon.wernhart@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: 6 weeks). 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 NCT07077005, which also lists 12 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 26 Dec 2025.

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