PIE II: Pharmacological Intervention in the Elderly II

Wake Forest University80 enrolled

Overview

The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).

Exercise intolerance due to HFPEF is a major cause of disability among older Americans. Several lines of evidence suggest that aldosterone antagonism may improve exercise tolerance in HFPEF. Therefore, the primary aim of this study is to test the hypothesis that spironolactone will improve exercise tolerance and quality of life in elderly patients with isolated HFPEF. A total of 72 participants aged 60 or older will be randomized to receive either spironolactone 25mg daily or a placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diastolic Heart Failure Heart Failure, Congestive

Interventions

SpironolactoneDRUG

25mg tablet daily for 9 months

PlaceboDRUG

Placebo tablet daily for 9 months

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ambulatory * Medically stable * Ages 60 or older * Diagnosis of diastolic heart failure Exclusion Criteria: * Valvular heart disease * Significant change in cardiac medication within the past 4 weeks * Uncontrolled hypertension * Recent or debilitating stroke * Cancer or other noncardiovascular conditions with life expectancy less than 2 years * Anemia * Elevated serum potassium * Renal insufficiency * Psychiatric disease (uncontrolled major psychoses, depression, dementia, or personality disorder) * Allergy to spironolactone; currently taking spironolactone or any aldosterone antagonist * Plans to leave area within 1 year * Refuses informed consent * Failure to pass screening tests: pulmonary function, echocardiogram, or exercise * Contra-indications to magnetic resonance imaging \[MRI\] (indwelling metal-containing prosthesis; pacemaker or defibrillator; history of welding occupation; uncontrollable claustrophobia)

Locations (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

Exercise Intolerance

Peak exercise VO2

Time frame: Baseline, 4 and 9 months

Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire-total Score

The Minnesota Living with Heart Failure Questionnaire (MLHF) is a self-administered disease-specific questionnaire for patients with Heart Failure, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score. Scale of 0-105:The higher the score the worse the heart failure related Quality of Life.

Time frame: Baseline, 4 and 9 months

Secondary Outcomes

Concentric Left Ventricular Remodeling

Left ventricle measurements by MRI: Mass/end diastolic volume ratio: g/ml

Time frame: Baseline, 9 month

Left Ventricular Diastolic Stiffness

Echocardiography Doppler measurement of left ventricular diastolic function: Early mitral annulus velocity (lateral) (Ea; cm/s)

Time frame: Baseline, 4 month and 9 month

Data from ClinicalTrials.gov

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