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PIE II: Pharmacological Intervention in the Elderly II

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ClinicalTrials.gov Identifier: NCT00123955
Recruitment Status : Completed
First Posted : July 26, 2005
Results First Posted : February 23, 2015
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Diastolic Heart Failure Heart Failure, Congestive Drug: Spironolactone Drug: Placebo Phase 3

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise Intolerance in Elderly Diastolic Heart Failure
Study Start Date : April 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Spironolactone
Drug: Spironolactone
25mg tablet daily for 9 months
Other Name: Aldactone
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo tablet daily for 9 months



Primary Outcome Measures :
  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 Outcome Measures :
  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)




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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123955


Locations
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Dalane W. Kitzman, MD Professor of Internal Medicine, Cardiology, Director of Echocardiography, Wake Forest University Health Sciences

Publications:

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00123955     History of Changes
Other Study ID Numbers: AG0030
R01AG018915 ( U.S. NIH Grant/Contract )
2R01AG018915-05 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2005    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: February 21, 2018
Last Verified: November 2017

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents