eCite Digital Repository

A randomized double-blind trial of an interventional device treatment of functional mitral regurgitation in patients with symptomatic congestive heart failure - Trial design of the REDUCE FMR study

Citation

Goldberg, SL and Meredith, I and Marwick, T and Haluska, BA and Lipiecki, J and Siminiak, T and Mehta, N and Kaye, DM and Sievert, H, for the REDUCE FMR Investigators, A randomized double-blind trial of an interventional device treatment of functional mitral regurgitation in patients with symptomatic congestive heart failure - Trial design of the REDUCE FMR study, American Heart Journal, 188 pp. 167-174. ISSN 0002-8703 (2017) [Contribution to Refereed Journal]


Preview
PDF
19Mb

Preview
PDF
284Kb

Copyright Statement

2017 The Authors. Published by Elsevier Inc. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) http://creativecommons.org/licenses/by-nc-nd/4.0/

DOI: doi:10.1016/j.ahj.2017.02.032

Abstract

The Carillon Mitral Contour System has been studied in 3 nonrandomized trials in patients with symptomatic congestive heart failure and functional mitral regurgitation. The REDUCE FMR study is a uniquely designed, double-blind trial evaluating the impact of the Carillon device on reducing regurgitant volume, as well as assessing the safety and clinical efficacy of this device. Carillon is a coronary sinus-based indirect annuloplasty device. Eligible patients undergo an invasive venogram to assess coronary sinus vein suitability for the Carillon device. If the venous dimensions are suitable, they are randomized on a 3:1 basis to receive a device or not. Patients and assessors are blinded to the treatment assignment. The primary end point is the difference in regurgitant volume at 1 year between the implanted and nonimplanted groups. Other comparisons include clinical parameters such as heart failure hospitalizations, 6-minute walk test, Kansas City Cardiomyopathy Questionnaire (KCCQ), and other echocardiographic parameters. An exercise echo substudy will also be included.

Item Details

Item Type:Contribution to Refereed Journal
Keywords:trial design, REDUCE FMR, functional mitral regurgitation, congestive heart failure
Research Division:Medical and Health Sciences
Research Group:Cardiorespiratory Medicine and Haematology
Research Field:Cardiology (incl. Cardiovascular Diseases)
Objective Division:Health
Objective Group:Clinical Health (Organs, Diseases and Abnormal Conditions)
Objective Field:Cardiovascular System and Diseases
UTAS Author:Haluska, BA (Dr Brian Haluska)
ID Code:124281
Year Published:2017
Web of Science® Times Cited:13
Deposited By:Menzies Institute for Medical Research
Deposited On:2018-02-16
Last Modified:2018-12-13
Downloads:47 View Download Statistics

Repository Staff Only: item control page