Effect of Aldosterone on Energy Starvation in Heart Failure

Heart Failure Clinical Trial

Official title:

Effect of Aldosterone on Energy Starvation in Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574119
• Other study ID #: IRB 070824
• Status: Completed
• Phase: Phase 4
• Start date: December 2007
• Est. completion date: July 2012

Study information

• Verified date: May 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Heart Failure
• Nonischemic Dilated Cardiomyopathy
• Starvation

Intervention

Drug:
• spironolactone
spironolactone 50 mg daily for 6 months

Locations

Country	Name	City	State
United States	Vanderbilt Heart and Vascular Institute	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Work-metabolic Index (WMI) at Baseline	WMI=[left ventricular stroke work/decay rate of 11C-acetate]	baseline
Primary	Left Ventricular Work-metabolic Index (WMI) at 6 Months	WMI=[left ventricular stroke work/decay rate of 11C-acetate]	6 months
Primary	Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline	MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope.	baseline
Primary	Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months	MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope.	6 months
Primary	Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging	T1=left ventricular relaxation rate on magnetic resonance imaging, which is correlated with interstitial fibrosis.	baseline and 6 months
Secondary	6 Minute Walk Test (6MWT) at Baseline	6MWT assesses distance walked over 6 minutes	baseline
Secondary	6 Minute Walk Test (6MWT) at 6 Months	6MWT assesses distance walked over 6 minutes	6 months
Secondary	Minnesota Living With Heart Failure Questionnaire,at Baseline	The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each question is scored from 0 (none or not applicable) to 5 (very much). Total scores range from 0-105. Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure.	baseline
Secondary	Minnesota Living With Heart Failure Questionnaire.at 6 Months	The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each question is scored from 0 (none or not applicable) to 5 (very much). Total scores range from 0-105. Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure.	6 months