Pulmonary HypertensionNCT01100008
Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion
A study testing Magnetic resonance imaging (MRI) in people with Pulmonary Hypertension, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Pulmonary hypertension is a rare severe disease leading to cardiac insufficiency. Treatment depends on the severity of the disease. This study evaluates cardiac MRI for the assessment of pulmonary hypertension severity and identification of parameters useful for the follow-up in order to adapt the medical treatment to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Magnetic resonance imaging (MRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Jun 2014
- 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
- Adults patients with pulmonary hypertension without specific treatment at inclusion
- Etiologies include chronic embolic disease, systemic fibrosis, Gougerot Sjogren, drug induced hypertension, primary hypertension.
- informed consent
- affiliated to medical insurance.
Who cannot join
- Left cardiac disease responsible for pulmonary hypertension, congenital cardiopathies
- Pulmonary functional tests with important impairment (decrease in TPCmore than 30%, decrease In VEMS more than 30%
- Child
- pregnancy
- contraindications to MRI
- without informed consent
- without insurance
Trial locations and contacts
1 site in 1 country.
France1 site
Service de radiologie - Hôpital Rangueil
Toulouse, Midi-Pyrénées, 31000
About this study
Official title: Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion: Its Role in the Diagnosis of the Severity of Pulmonary Hypertension in Adults and in the Follow-up. Preliminary Study.
Pulmonary hypertension is a rare severe disease leading to cardiac insufficiency. Treatment depends on the severity of the disease.
This study evaluates cardiac MRI for the assessment of pulmonary hypertension severity and identification of parameters useful for the follow-up in order to adapt the medical treatment to status of the patient.
Evaluate if cardiac MRI can obviate right cardiac catheterization in the follow-up.
Read the detailed description
Thirty patients will be enrolled and followed for 1 year after their inclusion.
Cardiac MRI will be performed at inclusion and at 3 months and 12 months. At the same periods, echocardiography and right heart catheterization will be performed too.
Morphological and functional parameters will be studied with MRI and correlated to invasive parameters and echocardiography too.
Morphological parameters are: volumes, cardiac cavities areas and ratios and position of the interventricular septum. Functional parameters are: ejection fractions of right and left cavities, flow in pulmonary artery, across mitral and tricuspid valves, temporal measurements in the pulmonary artery and auriculoventricular valves.
The invasive measurements are considered as the gold standard for this study. The classification of the severity is defined according to the parameters from right cardiac catheterization (4 grades with severity increasing between 1 and 4).
- Conditions
- Pulmonary Hypertension
- Being tested
- Magnetic resonance imaging (MRI)
- Keywords
- Pulmonary arterial hypertension, cardiac MRI (magnetic resonance imaging), severity, prognosis
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Procedure or surgery
MRI cardiac and pulmonary with gadolinium
| Study group | Role | What they receive |
|---|---|---|
| Magnetic resonance imaging | Experimental | Not described Receives: Procedure: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nuclear magnetic resonance imaging
Correlation of cardiac results from the first MRI (Magnetic Resonance Imaging) to invasive measurements from the first or initial right heart catheterization and to echocardiography to know if cardiac MRI is able to predict severity of the disease
Measured: Inclusion ; 3rd month ; 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startSep 2007
- Primary completionSep 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Chabbert, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100008
- Sponsor's protocol ID
- 06 042 02
- Status last verified
- Mar 2016
- First submitted
- 1 Mar 2010
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion: Its Role in the Diagnosis of the Severity of Pulmonary Hypertension in Adults and in the Follow-up. Preliminary Study.
- ClinicalTrials.gov ID
- NCT01100008
- Acronym / sponsor ID
- 06 042 02
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary arterial hypertension, cardiac MRI (magnetic resonance imaging), severity, prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Apr 2010 (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 hypertension is a rare severe disease leading to cardiac insufficiency. Treatment depends on the severity of the disease.
This study evaluates cardiac MRI for the assessment of pulmonary hypertension severity and identification of parameters useful for the follow-up in order to adapt the medical treatment to status of the patient.
Evaluate if cardiac MRI can obviate right cardiac catheterization in the follow-up.
Detailed description
Thirty patients will be enrolled and followed for 1 year after their inclusion.
Cardiac MRI will be performed at inclusion and at 3 months and 12 months. At the same periods, echocardiography and right heart catheterization will be performed too.
Morphological and functional parameters will be studied with MRI and correlated to invasive parameters and echocardiography too.
Morphological parameters are: volumes, cardiac cavities areas and ratios and position of the interventricular septum. Functional parameters are: ejection fractions of right and left cavities, flow in pulmonary artery, across mitral and tricuspid valves, temporal measurements in the pulmonary artery and auriculoventricular valves.
The invasive measurements are considered as the gold standard for this study. The classification of the severity is defined according to the parameters from right cardiac catheterization (4 grades with severity increasing between 1 and 4).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic resonance imaging | Experimental | Procedure: Magnetic resonance imaging (MRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults patients with pulmonary hypertension without specific treatment at inclusion
- Etiologies include chronic embolic disease, systemic fibrosis, Gougerot Sjogren, drug induced hypertension, primary hypertension.
- informed consent
- affiliated to medical insurance.
Key exclusion criteria (7 listed)
- Left cardiac disease responsible for pulmonary hypertension, congenital cardiopathies
- Pulmonary functional tests with important impairment (decrease in TPCmore than 30%, decrease In VEMS more than 30%
- Child
- pregnancy
- contraindications to MRI
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 |
|---|---|---|
| Magnetic resonance imaging (MRI)MRI cardiac and pulmonary with gadolinium | Procedure or surgery | Magnetic resonance imaging |
Primary outcome
Nuclear magnetic resonance imaging
Time frame: Inclusion ; 3rd month ; 12th month
Correlation of cardiac results from the first MRI (Magnetic Resonance Imaging) to invasive measurements from the first or initial right heart catheterization and to echocardiography to know if cardiac MRI is able to predict severity of the disease
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 14 Mar 2016.
- Individual participant dataSharing planned: No
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A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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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.
Valérie Chabbert, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging (MRI) in people with Pulmonary Hypertension, run by University Hospital, Toulouse at 1 site 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 4 inclusion and 7 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Nuclear magnetic resonance imaging (time frame: Inclusion ; 3rd month ; 12th month). 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 14 Mar 2016.