Study Looking at the Recovery of New Onset Cardiomyopathy

NCT00575211 | Completed DMC

• 2 other identifiers: IMAC IINIH grant
• Study Type: observational
• Target: 373
• Locations: 2 countries
• Sites: 16

Brief Summary

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.

Conditions

Cardiomyopathy

Keywords

New onset cardiomyopathy; Onset of symptoms less than 6 months; LVEF < 40%

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to determine whether variation in genetic background influences clinical outcomes in new onset cardiomyopathy.

  5 years

Secondary Outcomes (1)

• Determine whether cytokine or echo parameters can predict who will have significant recovery left ventricular function.

  5 years

Study Arms (1)

Cardiomyopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New onset Cardiomyopathy patient with symptoms less than 6 months

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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (16)

University of California - Irvine

Orange, California, 92868, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Wake Forest Univesity Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Southwestern Medical Center

Dalls, Texas, 75390, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

SBMB Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

• McNamara DM, Starling RC, Cooper LT, Boehmer JP, Mather PJ, Janosko KM, Gorcsan J 3rd, Kip KE, Dec GW; IMAC Investigators. Clinical and demographic predictors of outcomes in recent onset dilated cardiomyopathy: results of the IMAC (Intervention in Myocarditis and Acute Cardiomyopathy)-2 study. J Am Coll Cardiol. 2011 Sep 6;58(11):1112-8. doi: 10.1016/j.jacc.2011.05.033.

  PMID: 21884947 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

At time of enrollment, 30cc of blood will be obtained: 10cc for plasma banking for neurohormones and cytokine analysis, 10 cc for DNA banking and genotyping, 5 cc for evaluation of gene expression of inflammatory markers from circulating leukocytes and 5 cc for serum banking. Ten ccs of blood for cytokine analysis will also be collected at one month and six months after entry. A blood specimen for repeat analysis of serum mediator (5ccs in a red top tube) will be drawn at six months and sent to the University of Pittsburgh. All blood samples will be kept for 10 years. Access to the banked DNA will be limited to investigations at the University of Pittsburgh and each site of this multi-center trial. These samples will be available without any identifying information (name, social security number and medical record number). In addition, a Certificate of Confidentiality has been obtained from the NIH for further subject protection.

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dennis McNamara, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: January 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2011
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

US (14); CA (2)