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PIE II: Pharmacological Intervention in the Elderly II

Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diastolic Heart Failure; Heart Failure, Congestive

Intervention: Spironolactone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wake Forest School of Medicine

Official(s) and/or principal investigator(s):
Dalane W. Kitzman, MD, Principal Investigator, Affiliation: Professor of Internal Medicine, Cardiology, Director of Echocardiography, Wake Forest University Health Sciences


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).

Clinical Details

Official title: Exercise Intolerance in Elderly Diastolic Heart Failure

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Exercise Intolerance

Quality of Life

Secondary outcome:

Concentric Left Ventricular Remodeling

Left Ventricular Diastolic Stiffness

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.


Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.


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


- 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 and Contacts

Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157, United States
Additional Information

Related publications:

Kitzman DW, Little WC, Brubaker PH, Anderson RT, Hundley WG, Marburger CT, Brosnihan B, Morgan TM, Stewart KP. Pathophysiological characterization of isolated diastolic heart failure in comparison to systolic heart failure. JAMA. 2002 Nov 6;288(17):2144-50.

Kitzman DW, Higginbotham MB, Cobb FR, Sheikh KH, Sullivan MJ. Exercise intolerance in patients with heart failure and preserved left ventricular systolic function: failure of the Frank-Starling mechanism. J Am Coll Cardiol. 1991 Apr;17(5):1065-72.

Kitzman DW, Gardin JM, Gottdiener JS, Arnold A, Boineau R, Aurigemma G, Marino EK, Lyles M, Cushman M, Enright PL; Cardiovascular Health Study Research Group. Importance of heart failure with preserved systolic function in patients > or = 65 years of age. CHS Research Group. Cardiovascular Health Study. Am J Cardiol. 2001 Feb 15;87(4):413-9.

Zannad F, Alla F, Dousset B, Perez A, Pitt B. Limitation of excessive extracellular matrix turnover may contribute to survival benefit of spironolactone therapy in patients with congestive heart failure: insights from the randomized aldactone evaluation study (RALES). Rales Investigators. Circulation. 2000 Nov 28;102(22):2700-6. Erratum in: Circulation 2001 Jan 23;103(3):476.

Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999 Sep 2;341(10):709-17.

Cicoira M, Zanolla L, Franceschini L, Rossi A, Golia G, Zeni P, Caruso B, Zardini P. Relation of aldosterone "escape" despite angiotensin-converting enzyme inhibitor administration to impaired exercise capacity in chronic congestive heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol. 2002 Feb 15;89(4):403-7.

Kitzman DW, Herrington DM, Brubaker PH, Moore JB, Eggebeen J, Haykowsky MJ. Carotid arterial stiffness and its relationship to exercise intolerance in older patients with heart failure and preserved ejection fraction. Hypertension. 2013 Jan;61(1):112-9. doi: 10.1161/HYPERTENSIONAHA.111.00163. Epub 2012 Nov 12.

Daniel KR, Wells G, Stewart K, Moore B, Kitzman DW. Effect of aldosterone antagonism on exercise tolerance, Doppler diastolic function, and quality of life in older women with diastolic heart failure. Congest Heart Fail. 2009 Mar-Apr;15(2):68-74. doi: 10.1111/j.1751-7133.2009.00056.x.

Starting date: April 2005
Last updated: February 23, 2015

Page last updated: August 23, 2015

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