Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02579954
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : November 30, 2020
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Behavioral: Rehabilitation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension
Actual Study Start Date : August 6, 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
No Intervention: control group
Experimental: intervention
Behavioral: Rehabilitation
Other Name: Supervised rehabilitation

Primary Outcome Measures :
  1. Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET), [ Time Frame: 12 months after the inclusion ]

Secondary Outcome Measures :
  1. Right ventricular ejection fraction evaluated by RMN [ Time Frame: at 3 and 12 months ]
  2. Pulmonary haemodynamics : measurements at right heart catheterism [ Time Frame: at 3 and 12 months ]
    cardiac index (L/min/m²)

  3. Pulmonary haemodynamics : measurements at right heart catheterism [ Time Frame: at 3 and 12 months ]
    pressure in the right atrium (mmHg)

  4. Pulmonary haemodynamics : measurements at right heart catheterism [ Time Frame: at 3 and 12 months ]
    pulmonary resistance (uw)

  5. Pulmonary haemodynamics : measurements at right heart catheterism [ Time Frame: at 3 and 12 months ]
    mean pulmonary arterial pressure (mmHg)

  6. Functional class (NYHA classification) [ Time Frame: at 3 and 12 months ]
  7. 6 minutes walking distance (m) [ Time Frame: at 3 and 12 months ]
  8. Functional exercise capacity (oxygen consumption measurement during test) [ Time Frame: at 3 and 12 months ]
  9. Quality of life (SF-36 scale) [ Time Frame: at 3 and 12 months ]
  10. Time to clinical worsening (months) [ Time Frame: at 3 and 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02579954

Layout table for location contacts
Contact: Laurent BERTOLETTI, MD PhD 0477127770

Layout table for location information
CHU de Besançon Recruiting
Besancon, France, 25000
Contact: Bruno DEGANO, MD PhD   
Principal Investigator: Marie France SERONDE, MD         
Sub-Investigator: Malika BOUHADDI, MD         
Sub-Investigator: Pauline ROUX, MD         
CHU de Brest Recruiting
Brest, France, 39609
Contact: Francis COUTURAUD, MD PhD   
Principal Investigator: Francis COUTURAUD, MD PhD         
Sub-Investigator: Cécile TROMEUR, MD         
Sub-Investigator: Christophe GUT-GOBERT, MD         
Sub-Investigator: Cécile L'HEVEDER, MD         
Sub-Investigator: Philippe MIALON, MD         
CHU Gabriel Montpied Recruiting
Clermont Ferrand, France, 63000
Contact: Claire DAUPHIN, MD   
Principal Investigator: Claire DAUPHIN, MD         
Sub-Investigator: Frédéric COSTES, MD         
Sub-Investigator: Romain TRESORIER, MD         
Hôpital Sud de Grenoble Recruiting
Echirolles, France, 38130
Contact: Marianne NOIRCLERC, MD   
Principal Investigator: Marianne NOIRCLERC, MD         
Hôpital Nord de Grenoble Recruiting
Grenoble, France, 38043
Contact: Adrien JANKOWSKI, MD   
Principal Investigator: Adrien JANKOWSKI, MD         
Sub-Investigator: Gilbert FERRETTI, MD PhD         
Sub-Investigator: Gilles BARONE ROCHETTE, MD         
Sub-Investigator: Bernard WUYAM, MD         
Sub-Investigator: Hélène BOUVAIST, MD         
Sub-Investigator: Christophe PISON, MD         
Sub-Investigator: Bruno DEGANO, MD         
HCL - Hôpital Louis Pradel Recruiting
Lyon, France
Principal Investigator: Ségolène TURQUIER, MD         
Sub-Investigator: Vincent COTTIN, PhD         
Sub-Investigator: Clément DEUDON, MD         
Sub-Investigator: Julie TRACLET, MD         
Sub-Investigator: Sophie LAMOUREUX, MD         
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Arnaud BOURDIN, MD PhD   
Principal Investigator: Arnaud BOURDIN, MD PhD         
Sub-Investigator: Maurice HAYOT, MD PhD         
Sub-Investigator: Fares GOUZI, MD         
Sub-Investigator: Clément BOISSIN, MD         
Sub-Investigator: Jérémy CHARRIOT, MD         
Sub-Investigator: Anne-Sophie GAMEZ-DUBUIS, MD         
APHP - Hôpital Bicêtre Not yet recruiting
Paris, France
Principal Investigator: David MONTANI, MD         
Sub-Investigator: Antoine BEURNIER, MD         
Chu de Saint Etienne Recruiting
Saint Etienne, France, 42055
Contact: Laurent BERTOLETTI, MD PhD    0477127770 ext +33   
Sub-Investigator: Pierre CROISILLE, MD PhD         
Sub-Investigator: Laurence BISCH, MD         
Sub-Investigator: Jean-Baptiste GAULTIER, MD         
Sub-Investigator: Isabelle COURT FORTUNE, MD         
Sub-Investigator: Frédéric ROCHE, MD PhD         
Sub-Investigator: Sandrine ACCASSAT, MD         
Sub-Investigator: Stéphanie CHOMETTE- BALLEREAU, MD         
CHRU de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Irina ENACHE, MD   
Principal Investigator: Irina ENACHE, MD         
Sub-Investigator: Matthieu CANUET, MD         
Sub-Investigator: Evelyne LONSDORFER, MD         
Sub-Investigator: Armelle SCHULLER, MD         
Sub-Investigator: Marianne RIOU, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Layout table for investigator information
Principal Investigator: Laurent BERTOLETTI, MD PhD CHU de Saint Etienne
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne Identifier: NCT02579954    
Other Study ID Numbers: 1308156
2014-A00169-38 ( Other Identifier: ANSM )
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases