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Rehabilitation for Patients With Pulmonary Hypertension

A Randomized Controlled Trial to Evaluate the Effect of a Rehabilitation Program on the Exercise Capacity of Patients With Pulmonary Hypertension

NCT03955016•KU Leuven

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Summary

The purpose of this study is to test the impact of a personalized, partly supervised rehabilitation program on the exercise capacity in patients with pulmonary hypertension. The rehabilitation program consists of 2 weeks inpatient, 2 weeks ambulatory and 11 weeks home based rehabilitation.

Detailed Description

The present study is a 15 weeks, randomized (1:1) controlled trial. Patients in both groups will not change their usual medical treatment. After 2 clinical visits (screening and randomization visit), patients in the intervention group will follow a 15 week rehabilitation program consisting of 2 weeks inpatient, 2 weeks outpatient and 11 weeks home based rehabilitation. At the end of the outpatient rehabilitation phase (week 4) and the home-based program (week 15), clinical outcomes will be reassessed.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Female and male patients ≥ 18 years
•Pulmonary arterial hypertension (PAH, Group 1 of Nice classification) and chronic thromboembolic pulmonary hypertension (CTEPH, group 4)
•WHO functional class II-III
•PH diagnosed by right heart catheter showing:
•1. Baseline mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
•2. Baseline pulmonary vascular resistance (PVR) ≥ 240dyn x s x cm-5
•3. Baseline pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHgg
•Patients receiving optimized conventional PH therapy including intensified treatment with diuretics and who have been stable for 2 months before entering the study.
•Except for diuretics, medical treatment should not be expected to change during the entire 15-week study period.
•Negative pregnancy test (β-HCG) at the start of the trial and appropriate contraception throughout the study for women with child- bearing potential
+1 more criteria

Exclusion Criteria

•PH of any cause other than permitted in the entry criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease based on pulmonary edema during a previous vasoreactivity test or on abnormal findings compatible with this diagnosis (septal lines or pulmonary edema at high resolution computer tomography), congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension or unclear diagnosis
•Patients with signs of right heart decompensation
•Walking disability
•Acute infection, pyrexia
•Any change in disease-targeted therapy within the last 2 months
•Any subject who is scheduled to receive an investigational drug during the course of this study
•Severe lung disease: FEV1/FVC \<0.5 and total lung capacity \<70% of the normal value
•Active myocarditis, instable angina pectoris, exercise induced ventricular arrhythmias, decompensated heart failure, active liver disease, porphyria or elevations of serum transaminases \>3 x ULN (upper limit of normal) or bilirubin \>1.5 x ULN
•Hemoglobin concentration of less than 75% of the lower limit of normal
•Systolic blood pressure \<85 mmHg
+1 more criteria

Locations (1)

University Hospitals Leuven

Leuven, Belgium

Key Dates

Start Date

November 13, 2018

Primary Completion Date

November 1, 2020

Completion Date

November 1, 2020

Last Updated

October 10, 2019

Enrollment

ESTIMATED participants

Conditions

Pulmonary Hypertension

Interventions

Pulmonary rehabilitation

OTHER

Contacts

Wim Janssens, Prof

CONTACT

0032 16 34 68 33 wim.janssens@uzleuven.be

Marion Delcroix, Prof

CONTACT

marion.delcroix@uzleuven.be

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Rehabilitation for Patients With Pulmonary Hypertension

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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