Clinical trial NCT00574119: Effect of Aldosterone on Energy Starvation in Heart Failure
Official title: Effect of Aldosterone on Energy Starvation in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Nonischemic Dilated Cardiomyopathy
Keywords: heart failure
positron emission tomography
magnetic resonance imaging
myocardial energetics
myocardial perfusion
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2007-12-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: We plan to study the concept of "energy starvation" in heart failure by evaluation of patients with nonischemic dilated cardiomyopathy (NIDCM) (heart failure with reduced heart pump function due to causes other than heart attack). We will use a combination of positron emission tomography and magnetic resonance imaging to study metabolism, anatomy, function, blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart muscle).

Detailed description: Preliminary results showed reduced subendocardial myocardial perfusion reserve in NIDCM compared to normal subjects, and that the degree of impaired perfusion reserve was related to the oxidative metabolic rate as measured by positron emission tomography.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* 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 potassium \>5.0
* Serum creatinine \>2.5
* Contraindications to magnetic resonance imaging such as internal cardioverter-defibrillator.

Primary outcomes:
measure: Left Ventricular Work-metabolic Index (WMI) at Baseline
timeFrame: baseline
measure: Left Ventricular Work-metabolic Index (WMI) at 6 Months
timeFrame: 6 months
measure: Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline
timeFrame: baseline
measure: Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months
timeFrame: 6 months
measure: Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging
timeFrame: baseline and 6 months
Secondary outcomes:
measure: 6 Minute Walk Test (6MWT) at Baseline
timeFrame: baseline
measure: 6 Minute Walk Test (6MWT) at 6 Months
timeFrame: 6 months
measure: Minnesota Living With Heart Failure Questionnaire,at Baseline
timeFrame: baseline
measure: Minnesota Living With Heart Failure Questionnaire.at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Heart and Vascular Institute
state: Tennessee
Study officials:
affiliation: Vanderbilt University School of Medicine
name: Marvin W Kronenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.