Novel Treatment for Diastolic Heart Failure in Women

Study Overview
=================
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.

Official Title
-----------------
Novel Treatment for Diastolic Heart Failure in Women

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Spironolactone


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spironolactone<br>Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months. | Drug: Spironolactone<br>* Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.<br>* Other names: Aldactone;|
| Placebo Comparator: Placebo<br>Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months. | Drug: Spironolactone<br>* Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.<br>* Other names: Aldactone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk distance |  | Baseline, then 3 and 6 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiography parameters of diastolic function |  | Baseline, then 3 and 6 months after randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diastolic Heart Failure