Status:
COMPLETED
Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy
Lead Sponsor:
Tufts Medical Center
Conditions:
Myocardial Fibrosis
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Hypertrophic Cardiomyopathy (HCM) is the most common genetic cardiomyopathy and remains the leading cause of sudden cardiac death in young people and an important cause of heart failure symptoms and d...
Detailed Description
Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiac disease in the general population. Myocardial fibrosis has become a prominent and clinically relevant pathophysiologic component ...
Eligibility Criteria
Inclusion
- Hypertrophic cardiomyopathy
- Able to swallow pills
- No prior septal reduction therapy
- Negative serum or hCG pregnancy test
Exclusion
- Unable or unwilling to perform treadmill cardiopulmonary exercise test
- Prior surgical myectomy or alcohol septal ablation
- Known or suspected infiltrative or glycogen storage disease
- Significant coronary artery disease, defined as atherosclerotic coronary artery narrowing \>70% of the luminal diameter by coronary angiography
- Severe obstructive pulmonary disease, defined as forced expiratory volume in 1 second (FEV1) \<50% of predicted.
- Prior intolerance or adverse reaction to aldosterone receptor antagonist.
- History of hyper or hypoaldosteronism
- Baseline serum potassium \>5.0 mmol/L.
- Calculated creatinine clearance \<30 ml/min using Cockcroft-Gault formula.
- Pregnant or breast feeding
- Poorly controlled systemic hypertension, defined as systolic blood pressure ≥150 mmHg or diastolic pressure ≥100 mmHg, during 2 clinic visits.
- Known conditions associated with elevated serum concentrations of PIIINP (e.g., chronic liver disease, diabetes mellitus, tumors, pulmonary fibrosis, bone and rheumatoid diseases, extensive wounds) or PINP (e.g., alcoholic liver disease, metabolic bone disease, thyroid disorders), including recent trauma (≤2 weeks) or surgery (≤6 months)
- Taking drugs known to directly influence collagen metabolism including, amiodorone, ACE or angiotensin II inhibitors, aldosterone antagonists, statins, glucocorticoids and estrogens
- Patients with ICDs/pacemakers will be recruited in the study, but will be excluded from the CMR component.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00879060
Start Date
November 1 2007
End Date
November 1 2012
Last Update
April 27 2021
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111