PIE II: Pharmacological Intervention in the Elderly II

This study has been completed.
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dalane W. Kitzman, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
First received: July 22, 2005
Last updated: February 23, 2015
Last verified: February 2015
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 Intervention Phase
Diastolic Heart Failure
Heart Failure, Congestive
Drug: Spironolactone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise Intolerance in Elderly Diastolic Heart Failure

Resource links provided by NLM:

Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Exercise Intolerance [ Time Frame: Baseline, 4 and 9 months ] [ Designated as safety issue: No ]
    Peak exercise VO2

  • Quality of Life [ Time Frame: Baseline, 4 and 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Concentric Left Ventricular Remodeling [ Time Frame: Baseline, 4 and 9 months ] [ Designated as safety issue: No ]
  • Left Ventricular Diastolic Stiffness [ Time Frame: Baseline, 4 and 9 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2005
Study Completion Date: December 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Spironolactone
25mg tablet daily for 9 months
Other Name: Aldactone
Placebo Comparator: 2
Drug: Placebo
Placebo tablet daily for 9 months

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.

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123955

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


Responsible Party: Dalane W. Kitzman, Professor Internal Medicine Cardiology/Gerontology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00123955     History of Changes
Other Study ID Numbers: AG0030  R01AG018915  2R01 AG018915-05 
Study First Received: July 22, 2005
Results First Received: February 6, 2015
Last Updated: February 23, 2015
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on April 27, 2016