Noninvasive imaging assessment of rehabilitation therapy in heart failure with preserved and reduced left ventricular ejection fraction (IMAGING-REHAB-HF): design and rationale

Background: Studies have shown significant benefits of exercise therapy in heart failure (HF) with a reduced ejection fraction (HFrEF) and HF with a preserved ejection fraction (HFpEF). The mechanisms responsible for the beneficial effect of exercise in HFrEF and HFpEF are still unclear. We hypothes...

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Main Authors: Fernando Bianchini Cardoso, Lígia M. Antunes-Correa, Thiago Quinaglia A. C. Silva, Luis Miguel Silva, Camilla Toledo, Vinicius Citelli Ribeiro, Layde R. Paim, Tomas G. Neilan, Lício Velloso, Wilson Nadruz, Celso Darío Ramos, Sergio S. Dertkigil, Roberto Schreiber, Andrei Sposito, Jose Roberto Matos-Souza, Otávio Berwanger, Michael Jerosch-Herold, Otávio Rizzi Coelho-Filho
Format: Article
Language:English
Published: SAGE Publishing 2019-08-01
Series:Therapeutic Advances in Chronic Disease
Online Access:https://doi.org/10.1177/2040622319868376
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author Fernando Bianchini Cardoso
Lígia M. Antunes-Correa
Thiago Quinaglia A. C. Silva
Luis Miguel Silva
Camilla Toledo
Vinicius Citelli Ribeiro
Layde R. Paim
Tomas G. Neilan
Lício Velloso
Wilson Nadruz
Celso Darío Ramos
Sergio S. Dertkigil
Roberto Schreiber
Andrei Sposito
Jose Roberto Matos-Souza
Otávio Berwanger
Michael Jerosch-Herold
Otávio Rizzi Coelho-Filho
author_facet Fernando Bianchini Cardoso
Lígia M. Antunes-Correa
Thiago Quinaglia A. C. Silva
Luis Miguel Silva
Camilla Toledo
Vinicius Citelli Ribeiro
Layde R. Paim
Tomas G. Neilan
Lício Velloso
Wilson Nadruz
Celso Darío Ramos
Sergio S. Dertkigil
Roberto Schreiber
Andrei Sposito
Jose Roberto Matos-Souza
Otávio Berwanger
Michael Jerosch-Herold
Otávio Rizzi Coelho-Filho
author_sort Fernando Bianchini Cardoso
collection DOAJ
description Background: Studies have shown significant benefits of exercise therapy in heart failure (HF) with a reduced ejection fraction (HFrEF) and HF with a preserved ejection fraction (HFpEF). The mechanisms responsible for the beneficial effect of exercise in HFrEF and HFpEF are still unclear. We hypothesized that the effect of exercise on myocardial remodeling may explain its beneficial effect. Methods: IMAGING-REHAB-HF is a single-center, randomized, controlled clinical trial using cardiac magnetic resonance imaging, vasomotor endothelial function, cardiac sympathetic activity imaging and serum biomarkers to compare the effect of exercise therapy in HFpEF (LVEF ≥ 45%) and HFrEF (LVEF < 45%). Subjects will be assessed at baseline and after 4 months. The exercise program will consist of three 60-min exercise sessions/week. The primary endpoints are the effect of exercise on myocardial extracellular volume (ECV), left ventricular (LV) systolic function, LV mass, LV mass-to-volume and LV cardiomyocyte volume. Secondary endpoints include the effect of exercise on vasomotor endothelial function, cardiac sympathetic activity and plasmatic biomarkers. Patients will be allocated in a 2:1 fashion to supervised exercise program or usual care. A total sample size of 90 patients, divided into two groups according to LVEF:HFpEF group (45 patients:30 in the intervention arm and 15 in the control arm) and HFrEF group (45 patients:30 in the intervention arm and 15 in the control arm) – will be necessary to achieve adequate power. Conclusion: This will be the first study to evaluate the benefits of a rehabilitation program on cardiac remodeling in HF patients. The unique design of our study may provide unique data to further elucidate the mechanisms involved in reverse cardiac remodeling after exercise in HFpEF and HFrEF patients.
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spelling doaj.art-8020c66fd7da4f559dbf9df3065cb2352022-12-21T17:50:06ZengSAGE PublishingTherapeutic Advances in Chronic Disease2040-62312019-08-011010.1177/2040622319868376Noninvasive imaging assessment of rehabilitation therapy in heart failure with preserved and reduced left ventricular ejection fraction (IMAGING-REHAB-HF): design and rationaleFernando Bianchini CardosoLígia M. Antunes-CorreaThiago Quinaglia A. C. SilvaLuis Miguel SilvaCamilla ToledoVinicius Citelli RibeiroLayde R. PaimTomas G. NeilanLício VellosoWilson NadruzCelso Darío RamosSergio S. DertkigilRoberto SchreiberAndrei SpositoJose Roberto Matos-SouzaOtávio BerwangerMichael Jerosch-HeroldOtávio Rizzi Coelho-FilhoBackground: Studies have shown significant benefits of exercise therapy in heart failure (HF) with a reduced ejection fraction (HFrEF) and HF with a preserved ejection fraction (HFpEF). The mechanisms responsible for the beneficial effect of exercise in HFrEF and HFpEF are still unclear. We hypothesized that the effect of exercise on myocardial remodeling may explain its beneficial effect. Methods: IMAGING-REHAB-HF is a single-center, randomized, controlled clinical trial using cardiac magnetic resonance imaging, vasomotor endothelial function, cardiac sympathetic activity imaging and serum biomarkers to compare the effect of exercise therapy in HFpEF (LVEF ≥ 45%) and HFrEF (LVEF < 45%). Subjects will be assessed at baseline and after 4 months. The exercise program will consist of three 60-min exercise sessions/week. The primary endpoints are the effect of exercise on myocardial extracellular volume (ECV), left ventricular (LV) systolic function, LV mass, LV mass-to-volume and LV cardiomyocyte volume. Secondary endpoints include the effect of exercise on vasomotor endothelial function, cardiac sympathetic activity and plasmatic biomarkers. Patients will be allocated in a 2:1 fashion to supervised exercise program or usual care. A total sample size of 90 patients, divided into two groups according to LVEF:HFpEF group (45 patients:30 in the intervention arm and 15 in the control arm) and HFrEF group (45 patients:30 in the intervention arm and 15 in the control arm) – will be necessary to achieve adequate power. Conclusion: This will be the first study to evaluate the benefits of a rehabilitation program on cardiac remodeling in HF patients. The unique design of our study may provide unique data to further elucidate the mechanisms involved in reverse cardiac remodeling after exercise in HFpEF and HFrEF patients.https://doi.org/10.1177/2040622319868376
spellingShingle Fernando Bianchini Cardoso
Lígia M. Antunes-Correa
Thiago Quinaglia A. C. Silva
Luis Miguel Silva
Camilla Toledo
Vinicius Citelli Ribeiro
Layde R. Paim
Tomas G. Neilan
Lício Velloso
Wilson Nadruz
Celso Darío Ramos
Sergio S. Dertkigil
Roberto Schreiber
Andrei Sposito
Jose Roberto Matos-Souza
Otávio Berwanger
Michael Jerosch-Herold
Otávio Rizzi Coelho-Filho
Noninvasive imaging assessment of rehabilitation therapy in heart failure with preserved and reduced left ventricular ejection fraction (IMAGING-REHAB-HF): design and rationale
Therapeutic Advances in Chronic Disease
title Noninvasive imaging assessment of rehabilitation therapy in heart failure with preserved and reduced left ventricular ejection fraction (IMAGING-REHAB-HF): design and rationale
title_full Noninvasive imaging assessment of rehabilitation therapy in heart failure with preserved and reduced left ventricular ejection fraction (IMAGING-REHAB-HF): design and rationale
title_fullStr Noninvasive imaging assessment of rehabilitation therapy in heart failure with preserved and reduced left ventricular ejection fraction (IMAGING-REHAB-HF): design and rationale
title_full_unstemmed Noninvasive imaging assessment of rehabilitation therapy in heart failure with preserved and reduced left ventricular ejection fraction (IMAGING-REHAB-HF): design and rationale
title_short Noninvasive imaging assessment of rehabilitation therapy in heart failure with preserved and reduced left ventricular ejection fraction (IMAGING-REHAB-HF): design and rationale
title_sort noninvasive imaging assessment of rehabilitation therapy in heart failure with preserved and reduced left ventricular ejection fraction imaging rehab hf design and rationale
url https://doi.org/10.1177/2040622319868376
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