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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG018915 | U.S. NIH Grant/Contract | View source | |
| 2R01AG018915-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Spironolactone |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | 25mg tablet daily for 9 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Intolerance | Peak exercise VO2 | Baseline, 4 and 9 months |
| 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. | Baseline, 4 and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Concentric Left Ventricular Remodeling | Left ventricle measurements by MRI: Mass/end diastolic volume ratio: g/ml | Baseline, 9 month |
| Left Ventricular Diastolic Stiffness | Echocardiography Doppler measurement of left ventricular diastolic function: Early mitral annulus velocity (lateral) (Ea; cm/s) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalane W. Kitzman, MD | Professor of Internal Medicine, Cardiology, Director of Echocardiography, Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12413374 | Background | 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. | |
| 2007704 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spironolactone | Spironolactone Spironolactone: 25mg tablet daily for 9 months |
| FG001 | Placebo | Placebo Placebo: Placebo tablet daily for 9 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spironolactone | Spironolactone Spironolactone: 25mg tablet daily for 9 months |
| BG001 | Placebo | Placebo Placebo: Placebo tablet daily for 9 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exercise Intolerance | Peak exercise VO2 | The outcome measure data uses data from all participants with 4 and/or 9 month follow-up. Thirty-seven participants randomized to spironolactone and 35 participants randomized to placebo completed 4 months of follow-up, and 37 participants randomized to spironolactone and 34 participants randomized to placebo completed 9 months of follow-up. | Posted | Mean | Standard Deviation | ml/kg/min | Baseline, 4 and 9 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spironolactone | Spironolactone Spironolactone: 25mg tablet daily for 9 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for chest pain | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dalane Kitzman | Wake Forest Baptist Health | 336-716-3274 | dkitzman@wakehealth.edu |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Placebo | Drug | Placebo tablet daily for 9 months |
|
| Baseline, 4 month and 9 month |
| 11179524 | Background | 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. |
| 11094035 | Background | 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. |
| 10471456 | Background | 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. |
| 11835920 | Background | 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. |
| 23150511 | Background | 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. |
| 19379452 | Background | 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. |
| Death |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Peak VO2 (ml/kg/min) | Mean | Standard Deviation | ml/kg/min |
|
| Workload (Watts) | Mean | Standard Deviation | Watts |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 and 9 months |
|
|
|
| Secondary | Concentric Left Ventricular Remodeling | Left ventricle measurements by MRI: Mass/end diastolic volume ratio: g/ml | Posted | Mean | Standard Deviation | g/ml | Baseline, 9 month |
|
|
|
| Secondary | Left Ventricular Diastolic Stiffness | Echocardiography Doppler measurement of left ventricular diastolic function: Early mitral annulus velocity (lateral) (Ea; cm/s) | Posted | Mean | Standard Deviation | cm/s | Baseline, 4 month and 9 month |
|
|
|
| 6 |
| 42 |
| 0 |
| 42 |
| EG001 | Placebo | Placebo Placebo: Placebo tablet daily for 9 months | 6 | 38 | 0 | 38 |
| Elective surgery | General disorders | Systematic Assessment |
|
| Hospitalization for shortness of breath | Cardiac disorders | Systematic Assessment |
|
| Hospitalization for syncope | Cardiac disorders | Systematic Assessment |
|
| Hospitalization for hypotension | Cardiac disorders | Systematic Assessment |
|
| Hospitalization for angioedema | Vascular disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment | Motor vehicle accident |
|
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Final- 9 months |
|
| 9 month |
|