Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

— POpPART  

Official title:

Optimised Management After Balloon Pulmonary Angioplasty in Patients With Chronic Thromboembolic Pulmonary Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04777448
• Other study ID #: EssaiClinique_POPPART
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: July 2023

Study information

• Verified date: March 2021
• Source: University Hospital, Grenoble
• Contact: Bruno Degano, MD, PhD
• Phone: 04 76 76 50 85
• Email: BDegano[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: July 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary

Intervention

Procedure:
• telerehabilitation
24 sessions (less Thant 1h hour each) of tele rehabilitation. Patients can choose among several activities (gym, dance, cardio training, ...)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of endurance time on cycloergometer	Expressed in seconds and calculated as follow: endurance time after 3 months - endurance time at inclusion The two tests are performed at 80% of the maximum power reached during a maximum incremental effort test (performed before inclusion)	At inclusion and after 3 months
Secondary	6-minutes walking test (6MWT)	Distance walked in 6-min (in meters)	At inclusion and at Month 3
Secondary	3-minutes chair rise test (3-CRT)	Number of rises during 3-CRT (n)	At inclusion and at Month 3
Secondary	SF-36	Physical dimensions of the SF-36 questionnaire	At inclusion and at Month 3
Secondary	Dyspnea (NYHA scale)	Either I, II, III or IV	At inclusion, at Month 1, Month 2 and Month 3
Secondary	Telerehabilitation	Total number of sessions achieved	Through study completion, an average of 3 months
Secondary	St George Respiratory Questionnaire (SGRQ)	Total SGRQ score	At inclusion and at Month 3
Secondary	Dyspnea (mMRC score)	Either 0, 1, 2, 3 or 4	At inclusion, at Month 1, Month 2 and Month 3