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New treatment option for Cardiomyopathy, Hypertrophic
Official title Mavacamten Enables Exercise in Hypertrophic Obstructive Cardiomyopathy
ClinicalTrials.gov ID: NCT07077005
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- ≥ grade II valve insufficiencies or stenoses during resting echocardiography
- Prior implantable cardioverter defibrillator-implantation
- Sudden Cardiac Death Risk Score ≥4%
The study team makes the final eligibility decision.
Where it's taking place
- Munich, Bavaria, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Munich, Bavaria, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.