Pulmonary Arterial HypertensionFONCE-HTAPNCT02579954
Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension
A study testing Rehabilitation in people with Pulmonary Arterial Hypertension, run by Centre Hospitalier Universitaire de Saint Etienne at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 10 sitesFrance
- Study dates
- 6 Aug 2015to 24 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU de Besançon
Besançon, 25000
CHU de Brest
Brest, 39609
CHU Gabriel Montpied
Clermont-Ferrand, 63000
Hôpital Sud de Grenoble
Échirolles, 38130
Hôpital Nord de Grenoble
Grenoble, 38043
HCL - Hôpital Louis Pradel
Lyon
CHU de Montpellier
Montpellier, 34295
APHP - Hôpital Bicêtre
Paris
Chu de Saint Etienne
Saint-Etienne, 42055
CHRU de Strasbourg
Strasbourg, 67091
About this study
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Rehabilitation
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationBehavioural
Also called Supervised rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| intervention | Experimental | Rehabilitation Receives: Behavioral: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),
Measured: 12 months after the inclusion
Secondary outcomes (10)
Right ventricular ejection fraction evaluated by RMN
Measured: at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
cardiac index (L/min/m²)
Measured: at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
pressure in the right atrium (mmHg)
Measured: at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
pulmonary resistance (uw)
Measured: at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
mean pulmonary arterial pressure (mmHg)
Measured: at 3 and 12 months
Functional class (NYHA classification)
Measured: at 3 and 12 months
6 minutes walking distance (m)
Measured: at 3 and 12 months
Functional exercise capacity (oxygen consumption measurement during test)
Measured: at 3 and 12 months
Quality of life (SF-36 scale)
Measured: at 3 and 12 months
Time to clinical worsening (months)
Measured: at 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start6 Aug 2015
- Primary completion5 Dec 2022
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Laurent BERTOLETTI, MD PhD, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579954
- Sponsor's protocol ID
- 1308156
- Other IDs
- 2014-A00169-38
- Acronym
- FONCE-HTAP
- Status last verified
- Jun 2024
- First submitted
- 15 Oct 2015
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02579954
- Acronym / sponsor ID
- FONCE-HTAP / 1308156
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 6 Aug 2015 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| intervention | Experimental | Behavioral: RehabilitationRehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationAlso: Supervised rehabilitation | Behavioural | intervention |
Primary outcome
Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),
Time frame: 12 months after the inclusion
10 secondary outcomes
Right ventricular ejection fraction evaluated by RMN
Time frame: at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
Time frame: at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
Time frame: at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
Time frame: at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
Time frame: at 3 and 12 months
Functional class (NYHA classification)
Time frame: at 3 and 12 months
6 minutes walking distance (m)
Time frame: at 3 and 12 months
Functional exercise capacity (oxygen consumption measurement during test)
Time frame: at 3 and 12 months
Quality of life (SF-36 scale)
Time frame: at 3 and 12 months
Time to clinical worsening (months)
Time frame: at 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent BERTOLETTI, MD PhD principal investigator
CHU de Saint Etienne
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Pulmonary Arterial Hypertension, run by Centre Hospitalier Universitaire de Saint Etienne at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET), (time frame: 12 months after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024; AzTrials last refreshed its copy on 4 Nov 2026.