Lessons learned from a clinical trial: Design, rationale, and insights from The Cardiovascular Improvements with Minute Ventilation-targeted Adaptive Sero-Ventilation (ASV) Therapy in Heart Failure (CAT-HF) Study

Contemporary Clinical Trials
Mona FiuzatChristopher M O'Connor

Abstract

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. 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. 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...Continue Reading

References

Mar 28, 2003·The New England Journal of Medicine·Yasuyuki KanekoT Douglas Bradley
Sep 3, 2009·Current Heart Failure Reports·Sanja Jelic, Thierry H Le Jemtel
Jul 27, 2010·American Journal of Respiratory and Critical Care Medicine·Shahrokh JavaheriWilliam T Abraham
Sep 16, 2010·Circulation. Heart Failure·G Michael Felker, Alan S Maisel
Jun 7, 2013·Circulation·UNKNOWN WRITING COMMITTEE MEMBERSUNKNOWN American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines
Feb 1, 2015·European Heart Journal·Rami KhayatWilliam T Abraham
Sep 2, 2015·The New England Journal of Medicine·Martin R CowieHelmut Teschler

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Citations

Dec 3, 2014·Advanced Drug Delivery Reviews·Christine Tran, Margot S Damaser
Aug 24, 2016·Sleep & Breathing = Schlaf & Atmung·Zhuoshan HuangJinlai Liu
Jun 17, 2016·Journal of the American Heart Association·L Kristin Newby
Dec 5, 2019·The Cochrane Database of Systematic Reviews·Shuhei YamamotoRintaro Mori
Jun 29, 2018·The Cochrane Database of Systematic Reviews·Nicole MartinR Thomas Lumbers
Aug 16, 2017·Current Heart Failure Reports·Sushma M Dharia, Lee K Brown
Jun 19, 2018·American Heart Journal·Melissa A DaubertChristopher M O'Connor

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