Clinical trial NCT01058837: SCD-HeFT 10 Year Follow-up
Official title: Sudden Cardiac Death in Heart Failure Trial 10 Year Follow-up (SCD-HeFT 10 Year)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Left Ventricular Systolic Dysfunction
Congestive Heart Failure
Ischemic and Non-ischemic Cardiomyopathy
Sudden Cardiac Death Primary Prevention
Keywords: Sudden Cardiac Death
Implantable Cardioverter Defibrillator
Ventricular Fibrillation
Lead sponsor: Seattle Institute for Cardiac Research
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Abbott Medical Devices
First posted: 2010-01-29
Enrollment: 1855
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

-

Primary outcomes:
measure: 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.
timeFrame: Two years
Secondary outcomes:
measure: 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.
timeFrame: Two years
measure: To obtain 10-year ICD use rates (appropriate and inappropriate therapy), complication rates, lead failure rates and replacement rates.
timeFrame: Two Years
measure: To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients.
timeFrame: Two years
measure: To obtain 10-year hospitalization and major procedure data.
timeFrame: Two years
measure: To obtain 10-year quality of life data.
timeFrame: Two years
Other outcomes:
Locations:
city: Bellevue
country: United States
facility: Seattle Institute for Cardiac Research
state: Washington
Study officials:
affiliation: Seattle Institute for Cardiac Research
name: Gust H. Bardy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1056/NEJMoa043399.
citation: Poole JE, Olshansky B, Mark DB, Anderson J, Johnson G, Hellkamp AS, Davidson-Ray L, Fishbein DP, Boineau RE, Anstrom KJ, Reinhall PG, Packer DL, Lee KL, Bardy GH; SCD-HeFT Investigators. Long-Term Outcomes of Implantable Cardioverter-Defibrillator Therapy in the SCD-HeFT. J Am Coll Cardiol. 2020 Jul 28;76(4):405-415. doi: 10.1016/j.jacc.2020.05.061.