Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension (POpPART)

Grenoble Alpes University Hospital Center (CHU)

Status

Unknown

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Treatments

Procedure: telerehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT04777448

EssaiClinique_POPPART

Details and patient eligibility

About

Balloon pulmonary angioplasty (BPA) is a new method of treatment for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent CTEPH after surgery. BPA improves or even normalises hemodynamic parameters measured during a right heart catheterization. Nevertheless, the vast majority of patients retain dyspnea and impaired exercise capacity despite considerable hemodynamic improvements.

Pulmonary rehabilitation (RHB) can improve symptoms, quality of life and exercise capacity in patients with CTEPH. Unfortunately, access to RHB remains a concern in many countries. Tele-rehabilitation (tRHB) has been shown feasible and effective some cardiac or pulmonary diseases.

This randomized controlled study aims at comparing the effects of tRHB with the effects of simple advices regarding exercising in CTEPH patients with normalized or near-normalized pulmonary hemodynamics after BPA treatment.

Full description

Chronic thromboembolic pulmonary hypertension (CTEPH) is a complication of pulmonary embolism leading to dyspnea, effort limitation and sometimes right heart failure and death. Balloon pulmonary angioplasty (BPA) is a new method of treatment for inoperable CTEPH or persistent CTEPH after surgery. BPA restores blood flow in the treated areas and improves or even normalises hemodynamic parameters measured during a right heart catheterization. Nevertheless, the vast majority of patients retain dyspnea and impaired exercise capacity after angioplasty procedures.

Exercise training has been demonstrated to alleviate exercise dyspnea and to improve exercise capacity in many chronic cardiopulmonary conditions. Pulmonary rehabilitation (RHB) can improve symptoms, quality of life and exercise capacity in patients with pulmonary vascular disease of different etiologies including CTEPH. Furthermore, RHB does not present any particular risk for CTEPH patients with normalized or near-normalized pulmonary hemodynamics. Unfortunately, access to RHB remains a concern in many countries. Tele-rehabilitation (tRHB) has been shown feasible and effective some cardiac or pulmonary diseases. Our hypothesis is that tRHB may also be effective in CTEPH patients with normalized or near-normalized pulmonary hemodynamics after BPA treatment.

Enrollment

54 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 18 years old
Patients who have undergone pulmonary angioplasty for CTEPH (group 4 of the international classification)
Patients with a mean pulmonary artery pressure <= 30 mmHg and cardiac output > 2.5 L/min/m2 at the last angioplasty session
Patients who had completed an incremental cardiopulmonary exercise test
Patients affiliated to the French social security system
Patients with signed informed consent

Exclusion criteria

Patients unable to complete an incremental cardiopulmonary exercise test
Patients unable to complete a 6-minutes walking test, 3-minutes chair raising test and a rehabilitation
Patient unable, for technical or any other reason, to connect via the Internet for remote monitoring and/or telerehabilitation
Patient for whom a refusal to participate in a rehabilitation programme is anticipated
Patient who has participated in a rehabilitation programme in the 6 months prior to the date of inclusion
Patients referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant women, parturients, nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care and adults subject to a legal protection measure or unable to express their consent).