Effect of Aldosterone on Energy Starvation in Heart Failure
NCT ID: NCT00574119
Last Updated: 2019-06-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
16 participants
INTERVENTIONAL
2007-12-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Results with spironolactone
patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone.
spironolactone
spironolactone 50 mg daily for 6 months
Interventions
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spironolactone
spironolactone 50 mg daily for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Nonischemic dilated cardiomyopathy
* Left ventricular ejection fraction 35% or less
* Stable heart failure symptoms
* Able to undergo both positron emission tomography and magnetic resonance imaging with gadolinium
* Able to tolerate treatment with spironolactone
Exclusion Criteria
* Serum creatinine \>2.5
* Contraindications to magnetic resonance imaging such as internal cardioverter-defibrillator.
18 Years
ALL
No
Sponsors
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Vanderbilt University
OTHER
Responsible Party
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Marvin W. Kronenberg, M.D.
Professor of Medicine and Radiology
Principal Investigators
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Marvin W Kronenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University School of Medicine
Locations
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Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States
Countries
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References
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Lawson MA, Hansen DE, Gupta DK, Bell SP, Adkisson DW, Mallugari RR, Sawyer DB, Ooi H, Kronenberg MW. Modification of ventriculo-arterial coupling by spironolactone in nonischemic dilated cardiomyopathy. ESC Heart Fail. 2021 Apr;8(2):1156-1166. doi: 10.1002/ehf2.13161. Epub 2021 Jan 5.
Bradham WS, Bell SP, Huang S, Harrell FE Jr, Adkisson DW, Lawson MA, Sawyer DB, Ooi H, Kronenberg MW. Timing of Left Ventricular Remodeling in Nonischemic Dilated Cardiomyopathy. Am J Med Sci. 2018 Sep;356(3):262-267. doi: 10.1016/j.amjms.2018.06.003. Epub 2018 Jun 8.
Lawson MA, Bell SP, Adkisson DW, Wang L, Ooi H, Sawyer DB, Kronenberg MW. High reproducibility of adenosine stress cardiac MR myocardial perfusion imaging in patients with non-ischaemic dilated cardiomyopathy. BMJ Open. 2014 Dec 16;4(12):e005984. doi: 10.1136/bmjopen-2014-005984.
Bell SP, Adkisson DW, Lawson MA, Wang L, Ooi H, Sawyer DB, Kronenberg MW. Antifailure therapy including spironolactone improves left ventricular energy supply-demand relations in nonischemic dilated cardiomyopathy. J Am Heart Assoc. 2014 Aug 27;3(4):e000883. doi: 10.1161/JAHA.114.000883.
Bell SP, Adkisson DW, Ooi H, Sawyer DB, Lawson MA, Kronenberg MW. Impairment of subendocardial perfusion reserve and oxidative metabolism in nonischemic dilated cardiomyopathy. J Card Fail. 2013 Dec;19(12):802-10. doi: 10.1016/j.cardfail.2013.10.010. Epub 2013 Oct 29.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB 070824
Identifier Type: -
Identifier Source: org_study_id
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