Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777448
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2021-02-02
Brief Title:
Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Optimised Management After Balloon Pulmonary Angioplasty in Patients With Chronic Thromboembolic Pulmonary Hypertension
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POpPART
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None