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Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension (FONCE-HTAP)

Primary Purpose

Pulmonary Arterial Hypertension

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Rehabilitation

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

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

Inclusion Criteria:

Adult patients
Patients with Pulmonary Arterial Hypertension (idiopathic, heritable or due to anorexigens),
Prevalent cases of pulmonary artery hypertension (≥ 6 months) confirmed by right heart catheterism,
Stable for at least 3 months,
Written consent.

Exclusion Criteria:

Patients unable to proceed with six-minute walk test or CPET, or with contra-indication to exercise evaluation (syncope, low cardiac index, etc).
Exercise induced abnormality (evaluated during the initial CPET) precluding to further evaluation.

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

intervention

Arm Description

Rehabilitation

Outcomes

Primary Outcome Measures

Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),

Secondary Outcome Measures

Right ventricular ejection fraction evaluated by RMN

Pulmonary haemodynamics : measurements at right heart catheterism

cardiac index (L/min/m²)

Pulmonary haemodynamics : measurements at right heart catheterism

pressure in the right atrium (mmHg)

Pulmonary haemodynamics : measurements at right heart catheterism

pulmonary resistance (uw)

Pulmonary haemodynamics : measurements at right heart catheterism

mean pulmonary arterial pressure (mmHg)

Functional class (NYHA classification)

6 minutes walking distance (m)

Functional exercise capacity (oxygen consumption measurement during test)

Quality of life (SF-36 scale)

Time to clinical worsening (months)

Full Information

NCT ID

NCT02579954

First Posted

October 15, 2015

Last Updated

February 7, 2023

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT02579954

Brief Title

Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension

Acronym

FONCE-HTAP

Official Title

Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 6, 2015 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary vascular resistance inducing shortness of breath and exercise intolerance. We aim to correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to exercise capacity (evaluated by endurance time at 75% of maximal workout), in prevalent patients with pulmonary arterial hypertension, and their evolution at three and twelve months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

No Intervention

Arm Title

intervention

Arm Type

Experimental

Arm Description

Rehabilitation

Intervention Type

Behavioral

Intervention Name(s)

Rehabilitation

Other Intervention Name(s)

Supervised rehabilitation

Primary Outcome Measure Information:

Title

Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),

Time Frame

12 months after the inclusion

Secondary Outcome Measure Information:

Title

Right ventricular ejection fraction evaluated by RMN

Time Frame

at 3 and 12 months

Title

Pulmonary haemodynamics : measurements at right heart catheterism

Description

cardiac index (L/min/m²)

Time Frame

at 3 and 12 months

Title

Pulmonary haemodynamics : measurements at right heart catheterism

Description

pressure in the right atrium (mmHg)

Time Frame

at 3 and 12 months

Title

Pulmonary haemodynamics : measurements at right heart catheterism

Description

pulmonary resistance (uw)

Time Frame

at 3 and 12 months

Title

Pulmonary haemodynamics : measurements at right heart catheterism

Description

mean pulmonary arterial pressure (mmHg)

Time Frame

at 3 and 12 months

Title

Functional class (NYHA classification)

Time Frame

at 3 and 12 months

Title

6 minutes walking distance (m)

Time Frame

at 3 and 12 months

Title

Functional exercise capacity (oxygen consumption measurement during test)

Time Frame

at 3 and 12 months

Title

Quality of life (SF-36 scale)

Time Frame

at 3 and 12 months

Title

Time to clinical worsening (months)

Time Frame

at 3 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients Patients with Pulmonary Arterial Hypertension (idiopathic, heritable or due to anorexigens), Prevalent cases of pulmonary artery hypertension (≥ 6 months) confirmed by right heart catheterism, Stable for at least 3 months, Written consent. Exclusion Criteria: Patients unable to proceed with six-minute walk test or CPET, or with contra-indication to exercise evaluation (syncope, low cardiac index, etc). Exercise induced abnormality (evaluated during the initial CPET) precluding to further evaluation.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laurent BERTOLETTI, MD PhD

Phone

0477127770

laurent.bertoletti@chu-st-etienne.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurent BERTOLETTI, MD PhD

Organizational Affiliation

CHU de Saint Etienne

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Besançon

City

Besancon

ZIP/Postal Code

25000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruno DEGANO, MD PhD

bruno.degano@univ-fcomte.fr

First Name & Middle Initial & Last Name & Degree

Marie France SERONDE, MD

First Name & Middle Initial & Last Name & Degree

Malika BOUHADDI, MD

First Name & Middle Initial & Last Name & Degree

Pauline ROUX, MD

Facility Name

CHU de Brest

City

Brest

ZIP/Postal Code

39609

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francis COUTURAUD, MD PhD

francis.couturaud@chu-brest.fr

First Name & Middle Initial & Last Name & Degree

Francis COUTURAUD, MD PhD

First Name & Middle Initial & Last Name & Degree

Cécile TROMEUR, MD

First Name & Middle Initial & Last Name & Degree

Christophe GUT-GOBERT, MD

First Name & Middle Initial & Last Name & Degree

Cécile L'HEVEDER, MD

First Name & Middle Initial & Last Name & Degree

Philippe MIALON, MD

Facility Name

CHU Gabriel Montpied

City

Clermont Ferrand

ZIP/Postal Code

63000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claire DAUPHIN, MD

cdauphin@chu-clermontferrand.fr

First Name & Middle Initial & Last Name & Degree

Claire DAUPHIN, MD

First Name & Middle Initial & Last Name & Degree

Frédéric COSTES, MD

First Name & Middle Initial & Last Name & Degree

Romain TRESORIER, MD

Facility Name

Hôpital Sud de Grenoble

City

Echirolles

ZIP/Postal Code

38130

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marianne NOIRCLERC, MD

mnoirclerc@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Marianne NOIRCLERC, MD

Facility Name

Hôpital Nord de Grenoble

City

Grenoble

ZIP/Postal Code

38043

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Adrien JANKOWSKI, MD

AJankowski@chu-grenoble.fr

First Name & Middle Initial & Last Name & Degree

Adrien JANKOWSKI, MD

First Name & Middle Initial & Last Name & Degree

Gilbert FERRETTI, MD PhD

First Name & Middle Initial & Last Name & Degree

Gilles BARONE ROCHETTE, MD

First Name & Middle Initial & Last Name & Degree

Bernard WUYAM, MD

First Name & Middle Initial & Last Name & Degree

Hélène BOUVAIST, MD

First Name & Middle Initial & Last Name & Degree

Christophe PISON, MD

First Name & Middle Initial & Last Name & Degree

Bruno DEGANO, MD

Facility Name

HCL - Hôpital Louis Pradel

City

Lyon

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ségolène TURQUIER, MD

First Name & Middle Initial & Last Name & Degree

Vincent COTTIN, PhD

First Name & Middle Initial & Last Name & Degree

Clément DEUDON, MD

First Name & Middle Initial & Last Name & Degree

Julie TRACLET, MD

First Name & Middle Initial & Last Name & Degree

Sophie LAMOUREUX, MD

Facility Name

CHU de Montpellier

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arnaud BOURDIN, MD PhD

a-bourdin@chu-montpellier.fr

First Name & Middle Initial & Last Name & Degree

Arnaud BOURDIN, MD PhD

First Name & Middle Initial & Last Name & Degree

Maurice HAYOT, MD PhD

First Name & Middle Initial & Last Name & Degree

Fares GOUZI, MD

First Name & Middle Initial & Last Name & Degree

Clément BOISSIN, MD

First Name & Middle Initial & Last Name & Degree

Jérémy CHARRIOT, MD

First Name & Middle Initial & Last Name & Degree

Anne-Sophie GAMEZ-DUBUIS, MD

Facility Name

APHP - Hôpital Bicêtre

City

Paris

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David MONTANI, MD

First Name & Middle Initial & Last Name & Degree

Antoine BEURNIER, MD

Facility Name

Chu de Saint Etienne

City

Saint Etienne

ZIP/Postal Code

42055

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurent BERTOLETTI, MD PhD

Phone

0477127770

Ext

+33

laurent.bertoletti@chu-st-etienne.fr

First Name & Middle Initial & Last Name & Degree

Pierre CROISILLE, MD PhD

First Name & Middle Initial & Last Name & Degree

Laurence BISCH, MD

First Name & Middle Initial & Last Name & Degree

Jean-Baptiste GAULTIER, MD

First Name & Middle Initial & Last Name & Degree

Isabelle COURT FORTUNE, MD

First Name & Middle Initial & Last Name & Degree

Frédéric ROCHE, MD PhD

First Name & Middle Initial & Last Name & Degree

Sandrine ACCASSAT, MD

First Name & Middle Initial & Last Name & Degree

Stéphanie CHOMETTE- BALLEREAU, MD

Facility Name

CHRU de Strasbourg

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Irina ENACHE, MD

irina.enache@chru-strasbourg.fr

First Name & Middle Initial & Last Name & Degree

Irina ENACHE, MD

First Name & Middle Initial & Last Name & Degree

Matthieu CANUET, MD

First Name & Middle Initial & Last Name & Degree

Evelyne LONSDORFER, MD

First Name & Middle Initial & Last Name & Degree

Armelle SCHULLER, MD

First Name & Middle Initial & Last Name & Degree

Marianne RIOU, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension

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Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension (FONCE-HTAP)

Pulmonary Arterial Hypertension

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial