SCD-HeFT 10 Year Follow-up

NCT01058837 | Unknown

• 1 other identifier: 1RC1HL100625
• Study Type: observational
• Target: 1,855
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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.

  Two years

Secondary Outcomes (5)

• 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

• To obtain 10-year ICD use rates (appropriate and inappropriate therapy), complication rates, lead failure rates and replacement rates.

  Two Years

• To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients.

  Two years

• To obtain 10-year hospitalization and major procedure data.

  Two years

• To obtain 10-year quality of life data.

  Two years

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• This is a one time follow-up on patients previously enrolled. -

You may not qualify if:

• This is a one time follow-up on patients previously enrolled.

Sponsors & Collaborators

• Seattle Institute for Cardiac Research: lead
• National Institutes of Health (NIH): collaborator
• Abbott Medical Devices: collaborator

Study Sites (1)

Seattle Institute for Cardiac Research

Bellevue, Washington, 98004-2206, United States

Location

Related Publications (2)

• 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.

  PMID: 15659722 BACKGROUND

• 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.

  PMID: 32703511 DERIVED

Related Links

• Coordinating Center Website

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Heart Failure; Ischemia; Death, Sudden, Cardiac; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death; Arrhythmias, Cardiac

Study Officials

• Gust H. Bardy, MD

  Seattle Institute for Cardiac Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 29, 2010
• Study Start: September 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 11, 2010

Record last verified: 2010-02

Locations

US (1)