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

Primary Purpose

Chronic Thromboembolic Pulmonary Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
telerehabilitation
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Thromboembolic Pulmonary Hypertension focused on measuring Chronic Thromboembolic Pulmonary Hypertension, Telerehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    telerehabilitation

    Arm Description

    Simple physical activity advices will be given to the 27 patients of the control arm

    Patients in the tele rehabilitation arm will perform 24 1h-telerehabilition sessions (dance, gym, cardio training, yoga, ...)

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    6-minutes walking test (6MWT)
    Distance walked in 6-min (in meters)
    3-minutes chair rise test (3-CRT)
    Number of rises during 3-CRT (n)
    SF-36
    Physical dimensions of the SF-36 questionnaire
    Dyspnea (NYHA scale)
    Either I, II, III or IV
    Telerehabilitation
    Total number of sessions achieved
    St George Respiratory Questionnaire (SGRQ)
    Total SGRQ score
    Dyspnea (mMRC score)
    Either 0, 1, 2, 3 or 4

    Full Information

    First Posted
    February 2, 2021
    Last Updated
    March 1, 2021
    Sponsor
    University Hospital, Grenoble
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04777448
    Brief Title
    Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension
    Acronym
    POpPART
    Official Title
    Optimised Management After Balloon Pulmonary Angioplasty in Patients With Chronic Thromboembolic Pulmonary Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    April 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Grenoble

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Thromboembolic Pulmonary Hypertension
    Keywords
    Chronic Thromboembolic Pulmonary Hypertension, Telerehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Simple physical activity advices will be given to the 27 patients of the control arm
    Arm Title
    telerehabilitation
    Arm Type
    Experimental
    Arm Description
    Patients in the tele rehabilitation arm will perform 24 1h-telerehabilition sessions (dance, gym, cardio training, yoga, ...)
    Intervention Type
    Procedure
    Intervention Name(s)
    telerehabilitation
    Intervention Description
    24 sessions (less Thant 1h hour each) of tele rehabilitation. Patients can choose among several activities (gym, dance, cardio training, ...)
    Primary Outcome Measure Information:
    Title
    Difference of endurance time on cycloergometer
    Description
    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)
    Time Frame
    At inclusion and after 3 months
    Secondary Outcome Measure Information:
    Title
    6-minutes walking test (6MWT)
    Description
    Distance walked in 6-min (in meters)
    Time Frame
    At inclusion and at Month 3
    Title
    3-minutes chair rise test (3-CRT)
    Description
    Number of rises during 3-CRT (n)
    Time Frame
    At inclusion and at Month 3
    Title
    SF-36
    Description
    Physical dimensions of the SF-36 questionnaire
    Time Frame
    At inclusion and at Month 3
    Title
    Dyspnea (NYHA scale)
    Description
    Either I, II, III or IV
    Time Frame
    At inclusion, at Month 1, Month 2 and Month 3
    Title
    Telerehabilitation
    Description
    Total number of sessions achieved
    Time Frame
    Through study completion, an average of 3 months
    Title
    St George Respiratory Questionnaire (SGRQ)
    Description
    Total SGRQ score
    Time Frame
    At inclusion and at Month 3
    Title
    Dyspnea (mMRC score)
    Description
    Either 0, 1, 2, 3 or 4
    Time Frame
    At inclusion, at Month 1, Month 2 and Month 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bruno Degano, MD, PhD
    Phone
    04 76 76 50 85
    Ext
    +33
    Email
    BDegano@chu-grenoble.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bruno Degano, MD, PhD
    Organizational Affiliation
    CHU Grenoble Alpes
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Optimized Management After Balloon Pulmonary Angioplasty in Chronic Thromboembolic Pulmonary Hypertension

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