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Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)

2014-08-27 04:00:03 | BioPortfolio

Summary

To compare conventional treatment of congestive heart failure (CHF) with two experimental interventions: amiodarone and an implantable cardioverter-defibrillator (ICD).

Description

BACKGROUND:

Congestive heart failure is a major cause of mortality and morbidity, and sudden arrhythmic death is the cause of death in from 30 to 50 percent of those who die. The study addresses the problem and tests two interventions that have promise of benefit. To date, many of the therapies that have been tested for congestive heart failure have either been ineffective or actually decreased survival. Conventional therapy is still relatively ineffective in that recent studies such as the Congestive Heart Failure - Survival Trial of Antiarrhythmic Therapy (CHF-STAT) have demonstrated a mortality of 40 percent during two-and-half years of follow-up. The implantable cardioverter-defibrillator appears to be effective in patients who are resuscitated from cardiac arrest, but until recently, the devices required a thoracotomy and had to be reserved for patients with the highest risk for sudden death. The newer transvenous devices with pectoral patches can now be considered for broader applications. Although there have been mixed results with amiodarone in patients with congestive heart failure, there is a general consensus that it could be effective in the proper subset of patients with congestive heart failure. A comparison of the optimal device and drug is appropriate for such a high risk population.

DESIGN NARRATIVE:

Three-armed, randomized, multicenter trial conducted at over 125 North American, Australian and New Zealand sites. Patients were enrolled over 2.5 years after being randomly assigned to amiodarone, matched placebo or an implantable cardiac defibrillator (ICD). Median follow-up was 45.5 months. All three arms used conventional therapy for heart failure and coronary artery disease (ACE inhibitors, lipid lowering and beta-blockers). The central hypothesis was that amiodarone or the ICD would improve survival compared to placebo. The primary outcome was the prevention of all-cause mortality. Secondary outcome measures included cardiac mortality and arrhythmic mortality, morbidity, quality of life, and incremental cost-effectiveness of the interventions. .

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Conditions

Arrhythmia

Intervention

amiodarone, defibrillators, implantable

Status

Completed

Source

National Heart, Lung, and Blood Institute (NHLBI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:03-0400

Clinical Trials [344 Associated Clinical Trials listed on BioPortfolio]

Antiarrhythmics Versus Implantable Defibrillators (AVID)

To evaluate if use of an implantable cardiac defibrillator (ICD) results in reduction in total mortality, when compared with conventional pharmacological therapy, in patients resuscitated...

Implantable Cardioverter Defibrillators And Magnetic Resonance Imaging of the Heart at 1.5 Tesla

To evaluate short-term and long-term effects by MR imaging on the technical and functional status of implantable cardioverter defibrillators.

Catheter Ablation Versus Amiodarone for Shock Prophylaxis in Defibrillator Patients With Ventricular Tachycardia

Implantable Cardioverter Defibrillators (ICDs) provide a shock or pacing therapy to bring back a normal heart beat when a patient experiences a dangerous abnormal heart rhythm such as vent...

Coronary Artery Bypass Graft (CABG) Patch Trial

To test the hypothesis that implantable cardioverter defibrillator (ICD) therapy will improve survival in coronary heart disease patients at high risk of death, especially arrhythmic death...

Ranolazine Implantable Cardioverter-Defibrillator Trial

The purpose of the study is to see how effective a drug called ranolazine is in reducing the risk of ventricular arrhythmia and death in people with implantable cardioverter-defibrillators...

PubMed Articles [486 Associated PubMed Articles listed on BioPortfolio]

Clinical Course and Quality of Life in High-Risk Patients With Hypertrophic Cardiomyopathy and Implantable Cardioverter-Defibrillators.

High-risk patients with hypertrophic cardiomyopathy (HCM) are identified by contemporary risk stratification and effectively treated with implantable cardioverter-defibrillators (ICDs). However, long-...

Arrhythmic outcome of arrhythmogenic right ventricular cardiomyopathy patients without implantable defibrillators.

Implantable defibrillators (ICD) are an important therapy for arrhythmogenic right ventricular cardiomyopathy (ARVC) patients at high risk of sudden death. Given the high appropriate ICD therapy rate,...

Continuous ST-Monitoring Function of Implantable Cardioverter Defibrillator Detects Silent Ischemia in Patients With Coronary Artery Disease.

Newer implantable cardioverter defibrillators can monitor intracardiac ECGs , but their ability to detect ischemia is unclear. This study investigated the usefulness of implantable cardioverter defibr...

Amiodarone, a multi-channel blocker, enhances anticonvulsive effect of carbamazepine in the mouse maximal electroshock model.

Cardiac arrhythmia may occur in the course of epilepsy. Simultaneous therapy of the two diseases might be complicated by drug interactions since antiarrhythmic and antiepileptic agents share some mole...

Prognostic impact of electrical storm in patients with implantable cardioverter defibrillators: Mechanistic and therapeutic considerations to reduce the risk of death.

Medical and Biotech [MESH] Definitions

Types of artificial pacemakers with implantable leads to be placed at multiple intracardial sites. They are used to treat various cardiac conduction disturbances which interfere with the timing of contraction of the ventricles. They may or may not include defibrillating electrodes (IMPLANTABLE DEFIBRILLATORS) as well.

Implantable devices which continuously monitor the electrical activity of the heart and automatically detect and terminate ventricular tachycardia (TACHYCARDIA, VENTRICULAR) and VENTRICULAR FIBRILLATION. They consist of an impulse generator, batteries, and electrodes.

A potent anti-arrhythmia agent, effective in a wide range of ventricular and atrial arrhythmias and tachycardias. Paradoxically, however, in myocardial infarct patients with either symptomatic or asymptomatic arrhythmia, flecainide exacerbates the arrhythmia and is not recommended for use in these patients.

Cardiac electrical stimulators that apply brief high-voltage electroshocks to the HEART. These stimulators are used to restore normal rhythm and contractile function in hearts of patients who are experiencing VENTRICULAR FIBRILLATION or ventricular tachycardia (TACHYCARDIA, VENTRICULAR) that is not accompanied by a palpable PULSE. Some defibrillators may also be used to correct certain noncritical dysrhythmias (called synchronized defibrillation or CARDIOVERSION), using relatively low-level discharges synchronized to the patient's ECG waveform. (UMDNS, 2003)

A naturally occurring variation in heart rate that occurs during a BREATHING cycle, where the time between heartbeats is shortened during inspiration and prolonged during expiration. It is not the same as SINUS ARRHYTHMIA, the disorder.

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