Novel Treatment for Diastolic Heart Failure in Women

NCT ID: NCT00206232

Last Updated: 2013-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2010-07-31

Brief 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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Spironolactone

Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.

Group Type: ACTIVE_COMPARATOR

Spironolactone

Intervention Type: DRUG

Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.

Placebo

Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.

Group Type: PLACEBO_COMPARATOR

Spironolactone

Intervention Type: DRUG

Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.

Interventions

Spironolactone

Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.

Intervention Type: DRUG

Other Intervention Names

Aldactone

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Karla Kurrelmeyer

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karla M Kurrelmeyer, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine Heart Clinic

Houston, Texas, United States

Countries

United States

References

Kurrelmeyer KM, Ashton Y, Xu J, Nagueh SF, Torre-Amione G, Deswal A. Effects of spironolactone treatment in elderly women with heart failure and preserved left ventricular ejection fraction. J Card Fail. 2014 Aug;20(8):560-8. doi: 10.1016/j.cardfail.2014.05.010. Epub 2014 Jun 4.

Reference Type: DERIVED

PMID: 24905296 (View on PubMed)

Other Identifiers

H - 13988

Identifier Type: -

Identifier Source: org_study_id