Official Title: “Novel Treatment for Diastolic Heart Failure in Women”

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.

Study Type: Observational

Study Design: Prospective

Intervention(s) in this Clinical Trial

• Drug: Spironolactone

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Baylor College of Medicine

Overall Clinical Trial Officials and Contacts

Karla M Kurrelmeyer, MD Principal Investigator Baylor College of Medicine  

Overall Contact: Karla M Kurrelmeyer, MD 713-798-1405 karlak@bcm.tmc.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00206232

Study ID Number: H - 13988

ClinicalTrials.gov Identifier: NCT00206232

Health Authority: United States: Institutional Review Board