SCD-HeFT 10 Year Follow-up (SCD-HeFT10 Yr)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition |
|---|
|
Left Ventricular Systolic Dysfunction Congestive Heart Failure Ischemic and Non-ischemic Cardiomyopathy Sudden Cardiac Death Primary Prevention |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Sudden Cardiac Death in Heart Failure Trial 10 Year Follow-up (SCD-HeFT 10 Year) |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To obtain 10-year ICD use rates (appropriate and inappropriate therapy), complication rates, lead failure rates and replacement rates. [ Time Frame: Two Years ] [ Designated as safety issue: No ]
- To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients. [ Time Frame: Two years ] [ Designated as safety issue: No ]
- To obtain 10-year hospitalization and major procedure data. [ Time Frame: Two years ] [ Designated as safety issue: No ]
- To obtain 10-year quality of life data. [ Time Frame: Two years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1855 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
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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Contacts and Locations| United States, Washington | |
| Seattle Institute for Cardiac Research | |
| Bellevue, Washington, United States, 98004-2206 | |
| Principal Investigator: | Gust H. Bardy, MD | Seattle Institute for Cardiac Research |
More Information
Additional Information:
Publications:
| Responsible Party: | Gust H. Bardy, MD; Principal Investigator, Seattle Institute for Cardiac Research |
| ClinicalTrials.gov Identifier: | NCT01058837 History of Changes |
| Other Study ID Numbers: | 1RC1HL100625 |
| Study First Received: | January 26, 2010 |
| Last Updated: | February 9, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Seattle Institute for Cardiac Research:
|
Sudden Cardiac Death Implantable Cardioverter Defibrillator Ventricular Fibrillation |
Additional relevant MeSH terms:
|
Death Heart Failure Death, Sudden, Cardiac Cardiomyopathies Ventricular Dysfunction, Left Pathologic Processes |
Heart Diseases Cardiovascular Diseases Heart Arrest Death, Sudden Ventricular Dysfunction |
ClinicalTrials.gov processed this record on May 16, 2013