Rehabilitation for Patients With Pulmonary Hypertension

Catholic University (KU) of Leuven

Status

Unknown

Conditions

Pulmonary Hypertension

Treatments

Other: Pulmonary rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT03955016

S61141

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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
Able to understand and willing to sign the Informed Consent Form

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
History or suspicion of inability to cooperate adequately