Novel Treatment for Diastolic Heart Failure in Women

Heart Failure Clinical Trial

Official title:

Novel Treatment for Diastolic Heart Failure in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206232
• Other study ID #: H - 13988
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: February 15, 2013
• Start date: July 2004
• Est. completion date: July 2010

Study information

• Verified date: February 2013
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic

Intervention

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

Locations

Country	Name	City	State
United States	Baylor College of Medicine Heart Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procollagen peptides, troponin I, tumor necrosis factor alpha, Brain Natriuretic Peptide		Baseline then 3 and 6 months after randomization	No
Other	Electrolytes, blood urea nitrogen, creatinine		Screening and enrollment then 10 days, 4 weeks, 11 weeks, 13 weeks, and 15 weeks after randomization	Yes
Other	Quality of Life Questionaire		Baseline, then 3 and 6 months after randomization	No
Other	New York Heart Association Classification		Baseline then 3 and 6 months after randomization	No
Other	Number of participants with adverse events		From randomization until trial completion at 6 months.	Yes
Primary	Six minute walk distance		Baseline, then 3 and 6 months after randomization	No
Secondary	Echocardiography parameters of diastolic function		Baseline, then 3 and 6 months after randomization	No