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Completed

NCT Number: NCT00123955

PIE II: Pharmacological Intervention in the Elderly II

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).

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Key information

Conditions

Diastolic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Congestive Heart Failure, Diastolic

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Spironolactone

Drug

25mg tablet daily for 9 months

Other names: Aldactone

Placebo

Drug

Placebo tablet daily for 9 months

Primary outcomes

  1. Exercise Intolerance

    Time frame: Baseline, 4 and 9 months

    Peak exercise VO2

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

    Time frame: Baseline, 4 and 9 months

    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.

Secondary outcomes

  1. Concentric Left Ventricular Remodeling

    Time frame: Baseline, 9 month

    Left ventricle measurements by MRI:

    Mass/end diastolic volume ratio: g/ml

  2. Left Ventricular Diastolic Stiffness

    Time frame: Baseline, 4 month and 9 month

    Echocardiography Doppler measurement of left ventricular diastolic function:

    Early mitral annulus velocity (lateral) (Ea; cm/s)

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Exercise Intolerance in Elderly Diastolic Heart Failure

Important dates

Study start
2005
Primary completion
2009
Study completion
2012
First posted
Jul 26, 2005
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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