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SCD-HeFT 10 Year Follow-up (SCD-HeFT10 Yr)

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ClinicalTrials.gov Identifier: NCT01058837
Recruitment Status : Unknown
Verified February 2010 by Seattle Institute for Cardiac Research.
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2010
Last Update Posted : February 11, 2010
Information provided by:

Study Description
Brief Summary:
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 or disease
Left Ventricular Systolic Dysfunction Congestive Heart Failure Ischemic and Non-ischemic Cardiomyopathy Sudden Cardiac Death Primary Prevention

Detailed Description:

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.

Study Design

Study Type : Observational
Estimated Enrollment : 1855 participants
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)
Study Start Date : September 2009
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To obtain 10-year ICD use rates (appropriate and inappropriate therapy), complication rates, lead failure rates and replacement rates. [ Time Frame: Two Years ]
  3. To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients. [ Time Frame: Two years ]
  4. To obtain 10-year hospitalization and major procedure data. [ Time Frame: Two years ]
  5. To obtain 10-year quality of life data. [ Time Frame: Two years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058837

United States, Washington
Seattle Institute for Cardiac Research
Bellevue, Washington, United States, 98004-2206
Sponsors and Collaborators
Seattle Institute for Cardiac Research
National Institutes of Health (NIH)
St. Jude Medical
Principal Investigator: Gust H. Bardy, MD Seattle Institute for Cardiac Research
More Information

Additional Information:
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 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2010    Key Record Dates
Last Update Posted: February 11, 2010
Last Verified: February 2010

Keywords provided by Seattle Institute for Cardiac Research:
Sudden Cardiac Death
Implantable Cardioverter Defibrillator
Ventricular Fibrillation

Additional relevant MeSH terms:
Heart Failure
Death, Sudden, Cardiac
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden
Ventricular Dysfunction