SCD-HeFT 10 Year Follow-up

Status unconfirmed

Conditions studied: Left Ventricular Systolic Dysfunction, Congestive Heart Failure, Ischemic and Non-ischemic Cardiomyopathy, Sudden Cardiac Death Primary Prevention

In brief

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.

Key facts

Study ID
NCT01058837
Run by
Seattle Institute for Cardiac Research
People needed
1855
Starts
2009-09-01
Expected to finish
2011-08-01
Last updated by the study team
2010-02-11

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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