Study Looking at the Recovery of New Onset Cardiomyopathy

Completed

Conditions studied: Cardiomyopathy

In brief

This is a multi-center, prospective evaluation of left ventricular recovery on conventional therapy in patients with the recent onset of dilated cardiomyopathy. In some subjects with this disorder, the heart will recover significantly over the first year, while others will be left with a chronically weak heart. The proteins that help the heart recover are encoded by genes, which can differ markedly between individuals. The goal of the current study is to determine whether variation in these genes involved affect the probability that the heart will recover. We will also look at which genes are involved in inflammation and which ones are "turned on" (producing proteins) in circulating white blood cells.{These statements will only be added if the site has chosen to participate in RNA analysis}. In addition, this study will look at how levels of proteins in the blood, proteins called "cytokines' which control inflammation and proteins called "neurohormones" which are released when the heart weakens, affect the likelihood of recovery. Enrollment will take place at 15 centers. The goal is to enroll approximately 500 adult subjects (age 18 years or older, both men and women) over the course of approximately 48 months.

Key facts

Study ID: NCT00575211
Run by: University of Pittsburgh
People needed: 373
Starts: 2004-01-01
Expected to finish: 2011-03-01
Last updated by the study team: 2016-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must be 18 years or over, and may be of either gender and of any race.
Patients must have significantly systolic dysfunction, defined as a left ventricular ejection fraction of less than or equal to 40% by transthoracic echocardiography.
The patients must have a recent onset of dilated cardiomyopathy. Specifically, the initial signs or symptoms of cardiomyopathy should not pre-date the time of evaluation for the study by more than six months.
Subjects diagnosed during with peripartum cardiomyopathy (PPCM) are allowed as long as they are enrolled within six months of cardiac symptoms.
Subjects presenting with acute heart failure with a positive familial history of cardiomyopathy are included. Subjects who are asymptomatic, but are diagnosed with a cardiomyopathy of unknown duration during screening for known familial disease are excluded
Patients must be competent to give informed consent.

You may not qualify if…

Coronary artery disease as defined as a single coronary artery stenosis of a major epicardial vessel greater than 50% or a previous history of myocardial infarction.
Patients with a history of familial cardiomyopathy, or a primary relative defined as parents, siblings or children with a dilated cardiomyopathy are excluded.
Past or present history of alcoholism, or in whose current alcohol consumption exceeds an average of three drinks per day. A past history of cocaine or IV drug abuse as a possible explanation for their cardiomyopathy as well as substance abuse of prescription pain relievers or any illicit drug that may hinder the participant's ability to complete study follow-up.
Patients who are post cardiac transplant.
Patients whose heart failure is felt to be secondary to primary valvular disease, uncorrected thyroid disease, uncontrolled hypertension despite medical therapy, obstructive or hypertrophic cardiomyopathy, pericardial disease, or a systemic illness such as sarcoidosis.
Patients whose history of cardiac symptoms or signs of cardiac disease predate the time of evaluation by more than six months are excluded.
Evidence of ongoing bacteremia or sepsis. Patient with a febrile illness felt to be secondary to myocarditis can be included (even with a non-diagnostic biopsy) if a bacteriologic cause of the illness is excluded.
Patients with other life threatening diseases such as malignancy which would likely decrease their life expectancy over the next three years. Any history of malignancy treated with either chest radiation or chemotherapy.
The following patients are excluded for medical reasons: Patients with evidence of chronic liver disease (total bilirubin >3.0mg%) or chronic renal disease (creatinine > or equal to 2.5mg%) are excluded from the study. Subjects who present with an acute worsening of renal function or liver function tests in the setting of potentially fulminant myocarditis can be enrolled. Patients whose hepatic abnormalities are secondary to hypoperfusion can also be considered.
Patients with previous history of diabetes and with evidence of multisystem end organ damage (i.e. end stage renal disease and cardiomyopathy) or with evidence of any coronary disease. Patient with diabetes without significant end organ damage is allowed.
Patients enrolled in other placebo controlled experimental trials.
Patients who have had a myocardial biopsy, which reveals evidence of hemochromatosis, amyloid, sarcoidosis, or giant cell myocarditis, are excluded.

Where it is running

University of California - Irvine — Orange, California, United States
University of Florida — Gainesville, Florida, United States
Johns Hopkins University — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Mayo Clinic — Rochester, Minnesota, United States
Newark Beth Israel Medical Center — Newark, New Jersey, United States
University of Rochester Medical Center — Rochester, New York, United States
Wake Forest Univesity Health Sciences — Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States
Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Thomas Jefferson University — Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center — Dalls, Texas, United States
The Methodist Hospital — Houston, Texas, United States
University Health Network — Toronto, Ontario, Canada
SBMB Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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