Mona Fiuzat1, Olaf Oldenberg2, David J Whellan3, Holger Woehrle4, Naresh M Punjabi5, Kevin J Anstrom6, Amy B Blase4, Adam V Benjafield4, JoAnn Lindenfeld7, Christopher M O'Connor8. 1. Duke University, Duke Clinical Research Institute, Durham, NC, United States. Electronic address: mona.fiuzat@duke.edu. 2. Ruhr University Bochum, Bad Oeynhausen, Germany. 3. Thomas Jefferson University, Philadelphia, PA, United States. 4. ResMed Science Center, ResMed Corp., San Diego, CA, United States. 5. Johns Hopkins University, Baltimore, MD, United States. 6. Duke University, Duke Clinical Research Institute, Durham, NC, United States. 7. Vanderbilt University, Nashville, TN, United States. 8. Duke University, Duke Clinical Research Institute, Durham, NC, United States; Inova Heart and Vascular Institute, Falls Church, VA, United States.
Abstract
OBJECTIVE: The CAT-HF Study was designed to evaluate the safety and efficacy of minute ventilation-targeted adaptive servo-ventilation (MV-ASV) during sleep in addition to optimized medical therapy (active therapy) versus optimized medical therapy alone (usual care) at 6 months, initiated in patients after hospitalization for acute decompensated heart failure (ADHF). This paper outlines the rationale, design and information learned at the time of study discontinuation. BACKGROUND:Sleep disordered breathing (SDB) is common in heart failure patients and is associated with worse outcomes in this patient population. Based on a belief that MV-ASV was safe in stable HF patients, CAT-HF was designed to examine whether MV-ASV improved outcomes in hospitalized HF patients During the course of CAT-HF, new results from SERVE-HF indicated that ASV therapy may be harmful in patients with left ventricular ejection fractions (LVEF)≤45% and central sleep apnea, a subgroup of patients enrolled in CAT-HF. METHODS: CAT-HF was a prospective, randomized, controlled, multicenter clinical trial (NCT: 01953874) in HF patients with either reduced or preserved ejection fraction and an Apnea-Hypopnea Index ≥15 events per hour randomized to usual care or active treatment in a 1:1 ratio. 215 patients were intended to be randomized following a hospitalization for ADHF. At the time of discontinuation, 126 patients were randomized. The primary endpoint is a global rank composite endpoint of death, CV hospitalizations, and Six minute walk distance (6MWD). Secondary endpoints will include changes in functional parameters, biomarkers, quality of life (QOL), sleep, and breathing. CONCLUSIONS: The CAT-HF study was designed to assess the efficacy and safety of MV ASV treatment in patients after hospitalization for ADHF, but was stopped early due to safety concerns in HF patients with (LVEF)≤45% and predominant central sleep apnea.
RCT Entities:
OBJECTIVE: The CAT-HF Study was designed to evaluate the safety and efficacy of minute ventilation-targeted adaptive servo-ventilation (MV-ASV) during sleep in addition to optimized medical therapy (active therapy) versus optimized medical therapy alone (usual care) at 6 months, initiated in patients after hospitalization for acute decompensated heart failure (ADHF). This paper outlines the rationale, design and information learned at the time of study discontinuation. BACKGROUND:Sleep disordered breathing (SDB) is common in heart failurepatients and is associated with worse outcomes in this patient population. Based on a belief that MV-ASV was safe in stable HF patients, CAT-HF was designed to examine whether MV-ASV improved outcomes in hospitalized HF patients During the course of CAT-HF, new results from SERVE-HF indicated that ASV therapy may be harmful in patients with left ventricular ejection fractions (LVEF)≤45% and central sleep apnea, a subgroup of patients enrolled in CAT-HF. METHODS: CAT-HF was a prospective, randomized, controlled, multicenter clinical trial (NCT: 01953874) in HF patients with either reduced or preserved ejection fraction and an Apnea-Hypopnea Index ≥15 events per hour randomized to usual care or active treatment in a 1:1 ratio. 215 patients were intended to be randomized following a hospitalization for ADHF. At the time of discontinuation, 126 patients were randomized. The primary endpoint is a global rank composite endpoint of death, CV hospitalizations, and Six minute walk distance (6MWD). Secondary endpoints will include changes in functional parameters, biomarkers, quality of life (QOL), sleep, and breathing. CONCLUSIONS: The CAT-HF study was designed to assess the efficacy and safety of MV ASV treatment in patients after hospitalization for ADHF, but was stopped early due to safety concerns in HF patients with (LVEF)≤45% and predominant central sleep apnea.
Authors: Martin R Cowie; Holger Woehrle; Olaf Oldenburg; Thibaud Damy; Peter van der Meer; Erland Erdman; Marco Metra; Faiez Zannad; Jean-Noel Trochu; Lars Gullestad; Michael Fu; Michael Böhm; Angelo Auricchio; Patrick Levy Journal: Card Fail Rev Date: 2015-04