The CARE‐HF study (CArdiac REsynchronisation in Heart Failure study): rationale, design and end‐points

Abstract

Background: Cardiac resynchronisation is a promising new intervention for patients with heart failure, left ventricular systolic dysfunction and ventricular dyssynchrony. Objecti¨e: The CARE-HF trial is designed to evaluate the long-term effects Ž . of cardiac atrio-bi-ventricular resynchronisation on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal medical therapy with ACE inhibitors and beta-blockers Ž . where indicated and tolerated . Methods and Results: Approximately 800 patients will be randomised to device therapy or control and followed for a minimum of 18 months. A pragmatic study design has been chosen that does not attempt to conceal allocation from investigators or patients because it is impossible to guarantee maintenance of blinding for the duration of the study. The end-points committee will adjudicate events in a blinded fashion. Since cardiac resynchronisation may alter other aspects of the management of the patient, as would occur in clinical practice, the study should be considered a comparison of strategies rather than simply of a device. The primary end-point is all-cause mortality or unplanned cardiovascular hospitalisation. The study should complete recruitment during

How to Define Cardiac Resynchronization Therapy Response

“…4,5,[11][12][13][14][15][16][17] Patients with QRS widths of 120-150 ms have also been studied. 4,5,[11][12][13][14][15][16][17] CARE-HF 14 used echocardiographic determination to assess mechanical dyssynchrony for patients with QRS widths between 120 ms and 150 ms. A reduction in intraventricular dyssynchrony has been shown to predict CRT response. 18 QRS width has been shown to correlate well with interventricular dyssynchrony 19 but unfortunately has poor accuracy for detecting intraventricular dyssynchrony.…”

“…In REVERSE, the primary endpoint was met when QRS was 4152 ms. In MADIT-CRT, there was a 41% reduction in HF in patients with a QRS of 4150 ms. With respect to QRS width of 120-150 ms, the results of CARE-HF 14 suggest that an echo dyssynchrony evaluation can be potentially valuable. However, as previously mentioned, no reproducible single echo dyssynchrony parameter is predictive of CRT response to date.…”

All Patients With Heart Failure and Intraventricular Conduction Defect or Dyssynchrony Should Not Receive Cardiac Resynchronization Therapy

“…These 6 trials are the Multisite Stimulation in Cardiomyopathy (MUSTIC) studies, 26,27 the Multicenter InSync Randomized Clinical Evaluation (MIRACLE), 28,29 MIRACLE ICD, 30 the CONTAK CD trial, 31 the Cardiac Resynchronization in Heart Failure (CARE HF) trial, 32,33 and the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure (COMPANION) trial. 34,35 MUSTIC was designed to evaluate the safety and efficacy of CRT in patients with advanced heart failure, ventricular dyssynchrony, and either normal sinus rhythm 26 or atrial fibrillation.…”

“…32,33 Eight hundred nineteen patients with systolic heart failure and ventricular dyssynchrony, defined as a QRS duration Ն150 ms or a QRS duration between 120 and 150 ms with echocardiographic evidence of dyssynchrony, were enrolled in this randomized, unblinded, controlled trial and followed up for an average of 29.4 months. 33 Four hundred four patients were assigned to receive optimal medical therapy alone; 409 patients were randomized to optimal medical therapy plus CRT.…”

Heart failure – what’s new and what’s changed?

“…Medications targeting neurohormonal activation are the cornerstone of treatment, and they are complemented by device therapy and heart rate reduction, among other measures, in selected patients. [1][2][3][4] The net effect has been an effective doubling of life…”