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Novel Treatment for Diastolic Heart Failure in Women

Information source: Baylor College of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: Spironolactone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Baylor College of Medicine

Official(s) and/or principal investigator(s):
Karla M Kurrelmeyer, MD, Principal Investigator, Affiliation: Baylor College of Medicine

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Primary outcome: Six minute walk distance

Secondary outcome: Echocardiography parameters of diastolic function

Detailed description: Subjects with diastolic heart failure defined based on clinical symptoms, echocardiography diastology parameters and brain natriuretic peptide level will be randomized in a 1: 1 fashion to either placebo or spironolactone 25mg daily for 6 months. They will be assessed over this 6 month period for improvement in exercise capacity, clinical symptoms, echocardiography diastology parameters, and biomarkers specific for heart failure. Safety of spironolactone in this patient population will also be assessed by recording adverse events and following electrolytes, blood urea nitrogen, and creatinine levels.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women who are 18 years of age or older.

- Women with clinical heart failure for > 2 months.

- Women with left ventricular ejection fraction > 50% within 2 months of screening.

- Women with New York Heart Association class II or III heart failure symptoms.

- Brain Natriuretic Peptide > 62 pg/ml within 2 months of screening.

- Patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker

therapy for at least 1 month.

- Blood Pressure no more than 150/95.

- Patient able to walk more than 50 meters at the time of enrollment.

- 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 chronic lung

disease with cor pulmonale.

- Unstable angina or myocardial infarction within the past 4 weeks.

- Severe peripheral vascular disease or other physical conditions that would limit the

walking distance.

- Pregnant or lactating females.

- Participation in any other drug trial within 30 days prior to randomization.

- Inability to provide informed consent.

Locations and Contacts

Baylor College of Medicine Heart Clinic, Houston, Texas 77030, United States
Additional Information

Starting date: July 2004
Last updated: February 15, 2013

Page last updated: August 23, 2015

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