Training in HFpEF-PH

NCT05464238 | Not Yet Recruiting

• 1 other identifier: 2019-04ET
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief Summary

Exercise interventions alone or as a component of a comprehensive cardiac rehabilitation program for patients with heart failure (HFrEF and HFpEF) have already shown to reduce the risk of hospitalisations due to HF and improved exercise capacity and health-related quality of life. Two meta-analyses have confirmed the beneficial effects in cardiorespiratory fitness and quality of life. The effects of exercise training on systolic and diastolic function remain inconclusive. Due to the positive results of exercise training in HFpEF, cardiac rehabilitation is recommended (Class I, level A) to be integrated into the overall provision of HF care. However, none of these studies focused on concomitant PH in HFpEF. Exercise training in patients with pulmonary hypertension has already shown to improve exercise capacity, quality of life and peak oxygen consumption, which was confirmed by three meta-analyses and a Cochrane review. Though different diagnostic subgroups have already been enrolled in PH exercise training studies, they mainly included pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Data on combined PH and HFpEF is still lacking. As recently pointed out by Arena et al. there may thus be an exercise training volume/intensity which may be detrimental to the RV in patients with HF and concomitant PH. This study is sought to investigate whether a specialized training program is safe and tolerable and may improve exercise capacity, quality of life, hemodynamics, diastolic dysfunction and biomarkers in patients with PH and HFpEF.

Conditions

Pulmonary Hypertension Due to Left Heart Disease; Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 6-minute walking distance

  baseline to 15 weeks

Secondary Outcomes (14)

• WHO functional class

  baseline to 15 weeks

• Quality of life physical component scale SF-36

  baseline to 15 weeks

• Quality of life mental component scale SF-36

  baseline to 15 weeks

• peak oxygen consumption

  baseline to 15 weeks

• peak oxygen consumption/kg body weight

  baseline to 15 weeks

Study Arms (2)

Exercise training

ACTIVE COMPARATOR

Other: Exercise rehabilitation

Standard treatment (waiting group)

PLACEBO COMPARATOR

Other: Standard treatment

Interventions

Exercise rehabilitation OTHER

The initial phase of exercise training will be closely monitored and will be based on a three-weeks in-hospital stay to adjust and teach the exercise training which will be continued at home for 12 more weeks. In-hospital stays will be arranged country specific and hospitalization time may range. The rehabilitation program comprises of interval ergometer training (20 minutes 5 days per week), dumbbell training (30 minutes 5 days per week), respiratory therapy (30 minutes 5 days per week), mental training and guided walks for 2-5 times/week.

Exercise training

Standard treatment OTHER

Standard treatment during study duration

Standard treatment (waiting group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male patients ≥18 years
• WHO/NYHA functional class II - IV
• PH with HFpEF diagnosed by right heart catheterisation showing:
• mean pulmonary arterial pressure (mPAP) ≥25mmHg at rest; pulmonary arterial wedge pressure (PAWP) ≥15mmHg at rest or LVEDP ≥16mmHg and/or PAWP≥25 mmHg during exercise, and
• Preserved left ventricular ejection fraction ≥50%
• Patients receiving optimized therapy including intensified treatment with diuretics and who have been stable for 1 month before entering the study.
• Except for diuretics, medical treatment should not be changed during the study period.
• Able to understand and willing to sign the Informed Consent Form

You may not qualify if:

• Pre-capillary pulmonary hypertension (Group I; Group III; Group IV; Group V according to PH guidelines)
• Congenital or acquired severe valvular diseases (severe aortic stenosis or insufficiency, severe mitral valve stenosis or insufficiency)
• Pregnancy or lactation
• Walking disability
• Subject who participates in an interventional study during the course of this study
• Severe lung disease: FEV1/FVC \<0.5 and total lung capacity \<60% of the normal value
• Active myocarditis, unstable angina pectoris, exercise induced ventricular arrhythmias, active liver disease, porphyria or elevations of serum transaminases \>3 x ULN (upper limit of normal) or bilirubin \>1.5 x ULN
• Haemoglobin concentration less than 75% of the lower limit of normal
• Systolic blood pressure \<85 mmHg
• History or suspicion of inability to cooperate adequately.

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (2)

Centre for Pulmonary Hypertension at the Thoraxklinik Heidelberg, Heidelberg University Hospital

Heidelberg, 69126, Germany

Location

Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania

Vilnius, Lithuania

Location

Related Publications (1)

• Paleviciute E, Celutkiene J, Simbelyte T, Gumbiene L, Jureviciene E, Zakarkaite D, Cesna S, Eichstaedt CA, Benjamin N, Grunig E. 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. Trials. 2023 Apr 19;24(1):281. doi: 10.1186/s13063-023-07297-x.

  PMID: 37072812 DERIVED

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Ekkehard Grünig, MD

CONTACT

+496221396; ekkehard.gruenig@med.uni-heidelberg.de

Nicola Benjamin, MSc

CONTACT

+49 6221 396; nicola.benjamin@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of pulmonary hypertension centre, Thoraxklinik Heidelberg GgmbH

Model Details: Randomised, controlled, parallel-group with crossover of the control group

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 19, 2022
• Study Start: February 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); LI (1)