Novel Treatment for Diastolic Heart Failure in Women
Information source: Baylor College of Medicine
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Spironolactone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Baylor College of Medicine Official(s) and/or principal investigator(s):
Karla M Kurrelmeyer, MD, Principal Investigator, Affiliation: Baylor College of Medicine
Overall contact:
Karla M Kurrelmeyer, MD, Phone: 713-798-1405, Email: karlak@bcm.tmc.edu
Summary
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.
Clinical Details
Official title: Novel Treatment for Diastolic Heart Failure in Women
Study design: Prospective
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Karla M Kurrelmeyer, MD, Phone: 713-798-1405, Email: karlak@bcm.tmc.edu
Baylor College of Medicine Heart Clinic, Houston, Texas 77030, United States; Recruiting
Yelena Melendez, BBM, Phone: 713-790-6220, Email: melendez@bcm.tmc.edu
Karla M Kurrelmeyer, MD, Principal Investigator
Additional Information
Starting date: July 2004
Last updated: October 30, 2007
|
