An observational study in Left Ventricular Systolic Dysfunction, Congestive Heart Failure and Ischemic and Non-ischemic Cardiomyopathy, sponsored by Seattle Institute for Cardiac Research. Status unknown at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-02-11.
Sponsored by Seattle Institute for Cardiac Research · Observational
No clinical trial that has examined the role of implantable cardioverter defibrillator (ICD) therapy in the prevention of Sudden Cardiac Death (SCD) has provided outcome data for longer than a few years. The NHLBI sponsored and placebo-controlled Sudden Cardiac Death in heart Failure Trial (SCD-HeFT) conducted from 1997 to 2003 had the largest number of patients and the longest average follow-up at 45.5 months. This study changed the national reimbursement policy for ICD therapy and remains the reference point for all other ICD evaluations in patients with congestive heart failure from ischemic or non-ischemic systolic dysfunction. Despite the outcome, the role of ICD therapy in the management of patients with heart failure has been questioned because of four principal concerns: numbers needed to treat to save a life, lead integrity over time, the negative consequences of shock therapy, and the cost of therapy. The purpose of this trial is to track down the remaining patients for a one-time follow-up regarding key outcome data.
Long-term outcome data for implantable cardioverter defibrillator (ICD) therapy is sorely needed. We will acquire these data by re-approaching the patient population from the original Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).[Bardy 2005] This research is supported by the National Heart Lung and Blood Institute of the National Institutes of Health.
SCD-HeFT was originally conducted from 1997 to 2003. It demonstrated unequivocally that ICD's save lives in patients with heart failure compared to placebo or amiodarone. More than 26 peer-reviewed publications, including three NEJM papers, have resulted from this work.[Bardy 2005, Poole 2008, Mark 2008] Despite the quality of SCD-HeFT and the evidence of the life-saving ability of ICD therapy, the role of ICD therapy in the management of patients with heart failure continues to be questioned. This study will provide long-term follow-up of the SCD-HeFT patients, which will now exceed 10 years on average.
256 studies on the registry are indexed under Ventricular Dysfunction, Left; 52 are open to participants now.
This study's planned enrollment of 1,855 is above the median of 141 across 100 observational studies indexed under Ventricular Dysfunction, Left.
Browse Ventricular Dysfunction, Left studies →Seattle Institute for Cardiac Research is the lead sponsor of 2 studies on the registry; none are open to participants now.
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At the close of follow-up of the original SCD-HeFT study on October 31, 2003 there were a total of 666 deaths out of the enrollment population of 2521 patients. The American Recovery and Reinvestment Act (ARRA) of 2009 offers a perfect opportunity to do a one-time survey of the remaining 1855 patients from our last follow-up of October 31, 2003. Data on this population would allow us to obtain 10 year ICD follow-up data on the most detailed and largest ICD study ever done.
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This is a one time follow-up on patients previously enrolled. -
Exclusion Criteria:
This is a one time follow-up on patients previously enrolled.
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To compare 10-year mortality data on the remaining 1855 SCD-HeFT patients since the close of follow-up from October 31, 2003 in the 3 arms of the trial (ICD, placebo and amiodarone)based upon an intent-to-treat and an on-treatment analysis.
Time frame: Two years
To obtain outcome data in the major subgroups of SCD-HeFT: ischemic v. non-ischemic and NYHA Class II vs. Class III heart failure, and in woman and minorities.
Time frame: Two years
To obtain 10-year ICD use rates (appropriate and inappropriate therapy), complication rates, lead failure rates and replacement rates.
Time frame: Two Years
To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients.
Time frame: Two years
To obtain 10-year hospitalization and major procedure data.
Time frame: Two years
To obtain 10-year quality of life data.
Time frame: Two years
The record gives a start of Sep 2009, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Ventricular Dysfunction, Left →
Seattle Institute for Cardiac Research