Status:
COMPLETED
The Impact of Zinc Supplementation on Left Ventricular Function in Nonischemic Cardiomyopathy
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Heart Failure
Cardiomyopathies
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
Heart failure affects over 5.3 million Americans and, while other cardiovascular diseases have enjoyed a reduction in mortality rates over the last decade, the mortality from heart failure continues t...
Detailed Description
Altered regulation of the transition-metal copper (Cu) may lead to an overproduction of reactive oxygen species (ROS) with subsequent development of a nonischemic cardiomyopathy (NISCM). Myocardial Cu...
Eligibility Criteria
Inclusion
- Subjects (n=40) ≥21 years of age with chronic (≥1 year duration) nonischemic cardiomyopathy (NISCM), New York Heart Association (NYHA) functional class II-III symptoms on stable medical therapy (≥3 months of stable doses of β-blocker, angiotensin inhibitor or receptor blocker, and aldosterone inhibitor \[if appropriate\] therapies) with a documented left ventricular (LV) ejection fraction ≤40% and evidence of LV dilation will be eligible for study participation.
- The diagnosis of a nonischemic etiology for the cardiomyopathy must be supported by coronary angiography, stress echocardiography, or nuclear scintigraphy.
- To allow for a comparison of treatment effect in diabetic versus nondiabetic NISCM, half (n=20) of the subjects enrolled will be diabetic
Exclusion
- Subjects with HF that is deemed to be ischemic, congenital, valvular, or infiltrative in etiology, or chemotherapy/toxin-induced will not be eligible for enrollment.
- Other exclusion criteria include the presence of a life-threatening illness with a projected survival ≤6 months;
- recurrent ventricular arrhythmias; end-stage renal failure;
- ongoing infection;
- inability to follow-up;
- collagen vascular disease (lupus, sarcoid);
- enrollment in another investigational study;
- unstable or symptomatic peripheral artery disease;
- prior or active Zn supplementation;
- or ongoing alcohol abuse.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00696410
Start Date
June 1 2008
End Date
June 1 2011
Last Update
November 6 2017
Active Locations (1)
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1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109