Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy
ConditionCardiomyopathy, Hypertrophic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTechnical University of Munich
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise training
Other interventionSupervised, combined endurance and resistance training
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: ExerciseExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
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.
Time frame
6 weeksSecondary outcomes
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.
Time frame
6 weeks2
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.
Time frame
6 weeks3
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.
Time frame
6 weeks4
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.
Time frame
6 weeksSponsors and contacts
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Source ClinicalTrials.gov