Novel Treatment for Diastolic Heart Failure in Women
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | July 2004 |
| Contact: | Karla M Kurrelmeyer, MD |
| Email: | karlak@bcm.tmc.edu |
| Phone: | 713-798-1405 |
The purpose of the study is to collect information about the potential benefit and safety of
low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine
whether spironolactone can cause the patient's condition to improve.
Inclusion Criteria:
- Patient is 18 years of age or older.
- Patient has CHF for > 2 months
- Patient has LVEF > 50% within 2 months
- Patient with NYHA class II or III
- BNP > 62 pg/ml within 2 months of screening
- Patient on ACEI or ARB therapy for at least 1 month
- BP no more than 150/95
- Patient able to walk
- Signed informed consent.
Exclusion Criteria:
- Current treatment with spironolactone.
- Severe hepatic impairment.
- Creatinine > 2.5 mg/dl
- Potassium > 5.0 mEq/L
- Intolerance to spironolactone in the past.
- Significant valvular heart disease, pericardial disease, or severe COPD.
- Unstable angina or MI within the past 4 weeks.
- Severe vascular disease.
- Pregnant or lactating females.
- History of alcohol or substance abuse.
- History of cancer.
- Participation in any other drug trial within 30 days prior to randomization.
- Inability to provide informed consent.
- Patient on any CYP3A4s.
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