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New treatment option for Hypertrophic Cardiomyopathy
Official title Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy
ClinicalTrials.gov ID: NCT05818605
What this study is testing
- What it's testing
- The EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and cardiac function. About 70 participants will be recruited and randomized on a 1:1 ratio to either moderate intensity training or usual physicial activity interventions.
- Which group you join is decided by chance.
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 80
You may be able to join if
- Patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy1 defined by left ventricular hypertrophy with end-diastolic wall...
- Left ventricular outflow tract gradient \<30 mmHg at rest and with provocation.
- Left ventricular ejection fraction ≥ 50% by biplane Simpson's method.
- Access to exercise equipment at home or at a fitness center.
- Ability to complete study related testing including online surveys and smart phone use
You likely can't join if
- History of exercise-induced syncope or ventricular arrhythmias
- LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after
- History of septal reduction therapy - surgery or ablation
- History of ICD placement in the previous 3 months
- History of hypotensive response with exercise testing (\>20 mm Hg decrease of systolic blood pressure from baseline blood pressure or an initial...
- Clinical decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms or Canadian...
See the full eligibility criteria
- Patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy1 defined by left ventricular hypertrophy with end-diastolic wall thickness 15 mm or greater on 2D echocardiography in the absence of other...
- Left ventricular outflow tract gradient \<30 mmHg at rest and with provocation.
- Left ventricular ejection fraction ≥ 50% by biplane Simpson's method.
- Access to exercise equipment at home or at a fitness center.
- Ability to complete study related testing including online surveys and smart phone use
- Ability to perform 24 weeks of exercise training
- History of exercise-induced syncope or ventricular arrhythmias
- LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after
- History of septal reduction therapy - surgery or ablation
- History of ICD placement in the previous 3 months
- History of hypotensive response with exercise testing (\>20 mm Hg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic...
- Clinical decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms or Canadian Cardiovascular Society class IV angina symptoms
- Left ventricular ejection fraction less than 50% by echocardiography
- Life expectancy less than 12 months
- Pregnant or planned pregnancy
- Inability to exercise owing to any medical or other limitations
- Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study, if assigned to the non-exercise group.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. 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.