Back to resultsPIE II: Pharmacological Intervention in the Elderly II
Primary Purpose
Diastolic Heart Failure, Heart Failure, Congestive
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Spironolactone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diastolic Heart Failure
Eligibility 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)
Sites / Locations
- Wake Forest University Baptist Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Spironolactone
Placebo
Outcomes
Primary Outcome Measures
Exercise Intolerance
Peak exercise VO2
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.
Secondary Outcome Measures
Concentric Left Ventricular Remodeling
Left ventricle measurements by MRI:
Mass/end diastolic volume ratio: g/ml
Left Ventricular Diastolic Stiffness
Echocardiography Doppler measurement of left ventricular diastolic function:
Early mitral annulus velocity (lateral) (Ea; cm/s)
Full Information
NCT ID
NCT00123955
First Posted
July 22, 2005
Last Updated
February 12, 2019
Sponsor
Wake Forest University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT00123955
Brief Title
PIE II: Pharmacological Intervention in the Elderly II
Official Title
Exercise Intolerance in Elderly Diastolic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Heart Failure, Heart Failure, Congestive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Spironolactone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Other Intervention Name(s)
Aldactone
Intervention Description
25mg tablet daily for 9 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet daily for 9 months
Primary Outcome Measure Information:
Title
Exercise Intolerance
Description
Peak exercise VO2
Time Frame
Baseline, 4 and 9 months
Title
Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire-total Score
Description
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 Outcome Measure Information:
Title
Concentric Left Ventricular Remodeling
Description
Left ventricle measurements by MRI:
Mass/end diastolic volume ratio: g/ml
Time Frame
Baseline, 9 month
Title
Left Ventricular Diastolic Stiffness
Description
Echocardiography Doppler measurement of left ventricular diastolic function:
Early mitral annulus velocity (lateral) (Ea; cm/s)
Time Frame
Baseline, 4 month and 9 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalane W. Kitzman, MD
Organizational Affiliation
Professor of Internal Medicine, Cardiology, Director of Echocardiography, Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12413374
Citation
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. doi: 10.1001/jama.288.17.2144.
Results Reference
background
PubMed Identifier
2007704
Citation
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. doi: 10.1016/0735-1097(91)90832-t.
Results Reference
background
PubMed Identifier
11179524
Citation
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. doi: 10.1016/s0002-9149(00)01393-x.
Results Reference
background
PubMed Identifier
11094035
Citation
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. doi: 10.1161/01.cir.102.22.2700. Erratum In: Circulation 2001 Jan 23;103(3):476.
Results Reference
background
PubMed Identifier
10471456
Citation
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. doi: 10.1056/NEJM199909023411001.
Results Reference
background
PubMed Identifier
11835920
Citation
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. doi: 10.1016/s0002-9149(01)02261-5.
Results Reference
background
PubMed Identifier
23150511
Citation
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.
Results Reference
background
PubMed Identifier
19379452
Citation
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.
Results Reference
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PIE II: Pharmacological Intervention in the Elderly II
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