Clinical trial NCT04777448: Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension
Official title: Optimised Management After Balloon Pulmonary Angioplasty in Patients With Chronic Thromboembolic Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Chronic Thromboembolic Pulmonary Hypertension
Telerehabilitation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Difference of endurance time on cycloergometer
timeFrame: At inclusion and after 3 months
Secondary outcomes:
measure: 6-minutes walking test (6MWT)
timeFrame: At inclusion and at Month 3
measure: 3-minutes chair rise test (3-CRT)
timeFrame: At inclusion and at Month 3
measure: SF-36
timeFrame: At inclusion and at Month 3
measure: Dyspnea (NYHA scale)
timeFrame: At inclusion, at Month 1, Month 2 and Month 3
measure: Telerehabilitation
timeFrame: Through study completion, an average of 3 months
measure: St George Respiratory Questionnaire (SGRQ)
timeFrame: At inclusion and at Month 3
measure: Dyspnea (mMRC score)
timeFrame: At inclusion, at Month 1, Month 2 and Month 3
Other outcomes:
Locations:
Study officials:
affiliation: CHU Grenoble Alpes
name: Bruno Degano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: