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. 2023 Apr 19;24(1):281.
doi: 10.1186/s13063-023-07297-x.

Safety and effectiveness of standardized exercise training in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (TRAIN-HFpEF-PH): study protocol for a randomized controlled multicenter trial

Eglė Palevičiūtė  1 , Jelena Čelutkienė  2 , Toma Šimbelytė  2 , Lina Gumbienė  2 , Elena Jurevičienė  3 , Diana Zakarkaitė  2 , Sigitas Čėsna  2 , Christina A Eichstaedt  4   5 , Nicola Benjamin  4 , Ekkehard Grünig  4
Affiliations

Safety and effectiveness of standardized exercise training in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (TRAIN-HFpEF-PH): study protocol for a randomized controlled multicenter trial

Eglė Palevičiūtė et al. Trials. .

Abstract

Background: Left heart failure (HF) is characterized by an elevation in left-sided filling pressures, causing symptoms of dyspnea, impairing exercise capacity, and leading to pulmonary venous congestion and secondary pulmonary hypertension (PH). There is an increased incidence of PH associated with left heart disease, particularly with heart failure with preserved ejection fraction (HFpEF-PH). Treatment possibilities in HFpEF-PH are non-specific and very limited, thus additional pharmacological and non-pharmacological therapeutic strategies are needed. Various types of exercise-based rehabilitation programs have been shown to improve exercise capacity and quality of life (QoL) of HF and PH patients. However, no study focused on exercise training in the population of HFpEF-PH. This study is designed to investigate whether a standardized low-intensity exercise and respiratory training program is safe and may improve exercise capacity, QoL, hemodynamics, diastolic function, and biomarkers in patients with HFpEF-PH.

Methods: A total of 90 stable patients with HFpEF-PH (World Health Organization functional class II-IV) will be randomized (1:1) to receive a 15-week specialized low-intensity rehabilitation program, including exercise and respiratory therapy and mental gait training, with an in-hospital start, or standard care alone. The primary endpoint of the study is a change in 6-min walk test distance; secondary endpoints are changes in peak exercise oxygen uptake, QoL, echocardiographic parameters, prognostic biomarkers, and safety parameters.

Discussion: To date, no study has investigated the safety and efficacy of exercising specifically in the HFpEF-PH population. We believe that a randomized controlled multicenter trial, which protocol we are sharing in this article, will add important knowledge about the potential utility of a specialized low-intensity exercise and respiratory training program for HFpEF-PH and will be valuable in finding optimal treatment strategies for these patients.

Trial registration: ClinicalTrials.gov NCT05464238. July 19, 2022.

Keywords: Exercise training; Heart failure with preserved ejection fraction; Pulmonary hypertension; Randomized controlled trial; Study protocol.

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Conflict of interest statement

E.P. reports speaker honoraria fees from Johnson and Johnson and Medis Pharma outside this work.

J.Č. reports personal fees from AstraZeneca, Boehringer Ingelheim, Pfizer, Bayer, and Novartis outside this work.

E.G. reports research grants and speaker honoraria/consultancy fees from Actelion, Janssen, Bayer, MSD, Merck, and Ferrer and research grants to the institution from Acceleron, Actelion, Bayer, MSD, Janssen, Liquidia, United Therapeutics, and OMT outside the submitted work.

L.G. has received speaker’s fees from Actelion, Johnson & Johnson, and Medis Pharma outside the submitted work.

S.Č. reports honoraria fees from Medtronic, Bostopn Scientific, and Meril outside this work.

T.Š., C.A.E, N.B., E.J., and D.Z. declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The detailed timeline of the study
See this image and copyright information in PMC

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