SCD-HeFT 10 Year Follow-up

Congestive Heart Failure Clinical Trial

— SCD-HeFT10 Yr  

Official title:

Sudden Cardiac Death in Heart Failure Trial 10 Year Follow-up (SCD-HeFT 10 Year)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01058837
• Other study ID #: 1RC1HL100625
• Status: Active, not recruiting
• Phase: N/A
• First received: January 26, 2010
• Last updated: February 9, 2010
• Start date: September 2009
• Est. completion date: August 2011

Study information

• Verified date: February 2010
• Source: Seattle Institute for Cardiac Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1855
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiomyopathies
• Congestive Heart Failure
• Death
• Death, Sudden, Cardiac
• Heart Failure
• Ischemic and Non-ischemic Cardiomyopathy
• Left Ventricular Systolic Dysfunction
• Sudden Cardiac Death Primary Prevention
• Ventricular Dysfunction, Left

Locations

Country	Name	City	State
United States	Seattle Institute for Cardiac Research	Bellevue	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Institute for Cardiac Research	National Institutes of Health (NIH), St. Jude Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. Erratum in: N Engl J Med. 2005 May 19;352(20):2146. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Two years	No
Secondary	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.		Two years	No
Secondary	To obtain 10-year ICD use rates (appropriate and inappropriate therapy), complication rates, lead failure rates and replacement rates.		Two Years	No
Secondary	To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients.		Two years	No
Secondary	To obtain 10-year hospitalization and major procedure data.		Two years	No
Secondary	To obtain 10-year quality of life data.		Two years	No

External Links

•   Coordinating Center Website