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

1. marts 2021 opdateret af: University Hospital, Grenoble

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

54

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
Simple physical activity advices will be given to the 27 patients of the control arm
Eksperimentel: telerehabilitation
Patients in the tele rehabilitation arm will perform 24 1h-telerehabilition sessions (dance, gym, cardio training, yoga, ...)
Procedure: telerehabilitation
24 sessions (less Thant 1h hour each) of tele rehabilitation. Patients can choose among several activities (gym, dance, cardio training, ...)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference of endurance time on cycloergometer
Tidsramme: At inclusion and after 3 months
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
6-minutes walking test (6MWT)
Tidsramme: At inclusion and at Month 3
Distance walked in 6-min (in meters)
At inclusion and at Month 3
3-minutes chair rise test (3-CRT)
Tidsramme: At inclusion and at Month 3
Number of rises during 3-CRT (n)
At inclusion and at Month 3
SF-36
Tidsramme: At inclusion and at Month 3
Physical dimensions of the SF-36 questionnaire
At inclusion and at Month 3
Dyspnea (NYHA scale)
Tidsramme: At inclusion, at Month 1, Month 2 and Month 3
Either I, II, III or IV
At inclusion, at Month 1, Month 2 and Month 3
Telerehabilitation
Tidsramme: Through study completion, an average of 3 months
Total number of sessions achieved
Through study completion, an average of 3 months
St George Respiratory Questionnaire (SGRQ)
Tidsramme: At inclusion and at Month 3
Total SGRQ score
At inclusion and at Month 3
Dyspnea (mMRC score)
Tidsramme: At inclusion, at Month 1, Month 2 and Month 3
Either 0, 1, 2, 3 or 4
At inclusion, at Month 1, Month 2 and Month 3

Samarbejdspartnere og efterforskere

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Sponsor

University Hospital, Grenoble

Efterforskere

  • Ledende efterforsker: Bruno Degano, MD, PhD, Chu Grenoble Alpes

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. april 2021

Primær færdiggørelse (Forventet)

1. april 2023

Studieafslutning (Forventet)

1. juli 2023

Datoer for studieregistrering

Først indsendt

2. februar 2021

Først indsendt, der opfyldte QC-kriterier

1. marts 2021

Først opslået (Faktiske)

2. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EssaiClinique_POPPART

Plan for individuelle deltagerdata (IPD)

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