Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00879060
Eligibility Criteria:
Inclusion Criteria:
1. Hypertrophic cardiomyopathy
2. Able to swallow pills
3. No prior septal reduction therapy
4. Negative serum or hCG pregnancy test
Exclusion Criteria:
1. Unable or unwilling to perform treadmill cardiopulmonary exercise test
2. Prior surgical myectomy or alcohol septal ablation
3. Known or suspected infiltrative or glycogen storage disease
4. Significant coronary artery disease, defined as atherosclerotic coronary artery narrowing \>70% of the luminal diameter by coronary angiography
5. Severe obstructive pulmonary disease, defined as forced expiratory volume in 1 second (FEV1) \<50% of predicted.
6. Prior intolerance or adverse reaction to aldosterone receptor antagonist.
7. History of hyper or hypoaldosteronism
8. Baseline serum potassium \>5.0 mmol/L.
9. Calculated creatinine clearance \<30 ml/min using Cockcroft-Gault formula.
10. Pregnant or breast feeding
11. Poorly controlled systemic hypertension, defined as systolic blood pressure ≥150 mmHg or diastolic pressure ≥100 mmHg, during 2 clinic visits.
12. 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)
13. Taking drugs known to directly influence collagen metabolism including, amiodorone, ACE or angiotensin II inhibitors, aldosterone antagonists, statins, glucocorticoids and estrogens
14. Patients with ICDs/pacemakers will be recruited in the study, but will be excluded from the CMR component.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00879060
Study Brief:
Protocol Section:
NCT00879060