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

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ClinicalTrials.gov Identifier: NCT02579954
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
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

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 : July 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
No Intervention: control group
Experimental: intervention
Rehabilitation
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02579954


Contacts
Contact: Laurent BERTOLETTI, MD PhD 0477127770 laurent.bertoletti@chu-st-etienne.fr

Locations
France
CHU de Besançon Recruiting
Besancon, France, 25000
Contact: Bruno DEGANO, MD PhD       bruno.degano@univ-fcomte.fr   
Sub-Investigator: Marie France SERONDE, MD         
Sub-Investigator: Jean Charles DALPHIN, MD PhD         
Sub-Investigator: Malika BOUHADDI, MD         
CHU de Brest Recruiting
Brest, France, 39609
Contact: Francis COUTURAUD, MD PhD       francis.couturaud@chu-brest.fr   
CHU Gabriel Montpied Recruiting
Clermont Ferrand, France, 63000
Contact: Claire DAUPHIN, MD       cdauphin@chu-clermontferrand.fr   
Hôpital Sud de Grenoble Recruiting
Echirolles, France, 38130
Contact: Marianne NOIRCLERC, MD       mnoirclerc@chu-grenoble.fr   
Hôpital Nord de Grenoble Recruiting
Grenoble, France, 38043
Contact: Adrien JANKOWSKI, MD       AJankowski@chu-grenoble.fr   
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         
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Arnaud BOURDIN, MD PhD       a-bourdin@chu-montpellier.fr   
Sub-Investigator: Maurice HAYOT, MD PhD         
Sub-Investigator: Fares GOUZI, MD         
Chu de Saint Etienne Recruiting
Saint Etienne, France, 42055
Contact: Laurent BERTOLETTI, MD PhD    0477127770 ext +33    laurent.bertoletti@chu-st-etienne.fr   
Sub-Investigator: Frédéric COSTES, MD         
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: Nathalie GLAS, MD         
Sub-Investigator: Frédéric ROCHE, MD PhD         
Sub-Investigator: Alexie GATE MARTINET, MD         
CHRU de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Irina ENACHE, MD       irina.enache@chru-strasbourg.fr   
Sub-Investigator: Matthieu CANUET, MD         
Sub-Investigator: Evelyne LONSDORFER, MD         
Sub-Investigator: Stéphane DOUTRELEAU, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Laurent BERTOLETTI, MD PhD CHU de Saint Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02579954     History of Changes
Other Study ID Numbers: 1308156
2014-A00169-38 ( Other Identifier: ANSM )
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases