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...
Brief Summary
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: Time Perspective: Prospective
Intervention(s) in this Clinical Trial
- Drug: Spironolactone
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Baylor College of Medicine Other
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
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00206232
