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

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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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