An exploratory study on the efficacy and safety of a BCAA preparation used in combination with cardiac rehabilitation for patients with chronic heart failureReport as inadecuate




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BMC Cardiovascular Disorders

, 17:205

Non-coronary artery cardiac disease

Abstract

BackgroundSarcopenia is generally complicated with patients with chronic heart failure CHF and its presence negatively affects the course of heart failure, however effective nutritional intervention had not been elucidated yet. The primary objective of this study is to explore whether the addition of a branched-chain amino acid BCAA preparation for cardiac rehabilitation CR of patients with CHF further improves cardiopulmonary functions, skeletal muscle functions, and metabolism in comparison with conventional CR.

MethodsThis is a randomized, parallel-group comparative study. The elderly patients that were participated in CR and complicated with left ventricular systolic or diastolic dysfunction are randomized into two groups, CR + BCAA and CR. 20 weeks later, the second randomization is performed, which divide subjects into two groups with and without BCAA intervention without CR. Primary outcome measure is the rate of change of the anaerobic threshold workload from baseline to post-intervention. Secondary outcome include parameters of exercise capacity, cardiac function and psychological status.

DiscussionIn the current study the effect of a promising new intervention, BCAA, will be assessed to determine whether its addition to CR improve exercise capacity in patients with heart failure, who are generally complicated with sarcopenia.

Trial registrationThis clinical trial was registered with the University Hospital Medical Information Network—Clinical Trials Registry UMIN–CTR; JPRN–UMIN R000022440.

AbbreviationsATAnaerobic threshold

BCAABranched-chain amino acid

CBCComplete blood count

CHFChronic heart failure

Co-ICoinvestigator

CPXCardiopulmonary exercise test

EDCElectronic data capture

EFEjection fraction

HADSHospital anxiety and depression scale

ICH-GCPInternational Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use

IL-6Interleukin-6

PIPrincipal investigator

SAEsSerious adverse events

TNFTumor necrosis factor

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Author: Munenori Takata - Eisuke Amiya - Masafumi Watanabe - Yumiko Hosoya - Atsuko Nakayama - Takayuki Fujiwara - Masanobu Taya -

Source: https://link.springer.com/



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