Pulmonary Arterial Hypertension (PAH)NCT03523910
Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension
A study testing Magnetic Resonance Imaging (MRI) with exercise in people with Pulmonary Arterial Hypertension (PAH), run by University of Wisconsin, Madison.
Trial summary
The goals of this study were two-fold. First, the attempt to quantify the relationships between pulmonary arterial stiffness, right ventricular function and the efficiency of ventricular-vascular interactions in patients with pulmonary arterial hypertension (PAH). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- Magnetic Resonance Imaging (MRI) with exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2012to 13 Feb 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of pulmonary arterial hypertension or a subtype
- Referred for right heart catheterization
- Age between 18 and 80 years
- New York Heart Association (NYHA) functional class I, II, or III
Who cannot join
- Recent syncope (within 1 year)
- Severe skeletal or muscle abnormalities prohibiting exercise
- Mixed etiology pulmonary arterial hypertension
- Severe lung disease
- Test results indicating severe obstruction
- Total lung capacity < 60%
Show all 11Show fewer
- Pregnancy or breastfeeding
- NYHA class IV patient
- Contraindications to magnetic resonance imaging
- Kidney dysfunction as determined by an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73m2
- Contraindication to gadolinium
About this study
The goals of this study were two-fold. First, the attempt to quantify the relationships between pulmonary arterial stiffness, right ventricular function and the efficiency of ventricular-vascular interactions in patients with pulmonary arterial hypertension (PAH). Second, the attempt to quantify the effects of exercise on pulmonary arterial stiffness, pulmonary vascular resistance, right ventricular function and the efficiency of ventricular-vascular interactions in patients with PAH.
Read the detailed description
The goals of this study are to quantify right ventricular-pulmonary vascular interactions in different types of PAH, to determine the temporal changes in these interactions with PAH progression and to quantify the effects of exercise on right ventricular function. The inclusion of the subpopulation of PAH patients with systemic sclerosis (SSc) was a result of the anticipation that this group has worse arterial stiffening than other groups, and consequently more inefficient right ventricular-pulmonary vascular interactions, which account for their worse prognosis.
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Being tested
- Magnetic Resonance Imaging (MRI) with exercise
- 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.
Magnetic Resonance Imaging (MRI) with exerciseDevice
Also called MRI
MRI scan with a novel exercise device.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | A research MRI scan with exercise will be obtained in conjunction with standard of care cardiopulmonary testing. Receives: Device: Magnetic Resonance Imaging (MRI) with exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to comprehensively quantify right ventricular and pulmonary vascular function at rest and with exercise using magnetic resonance imaging.
The hypotheses will be tested by comprehensively quantifying ventricular and vascular function in subjects with idiopathic pulmonary arterial hypertension, systemic sclerosis pulmonary arterial hypertension, and chronic thromboembolic pulmonary hypertension, using investigational magnetic resonance angiography techniques.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start25 Apr 2012
- Primary completion13 Feb 2017
- Study completion13 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Model description
- Single center, open label, single-arm
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christopher Francois, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523910
- Sponsor's protocol ID
- 2015-1526
- Other IDs
- 1R01HL105598-01A1
- Status last verified
- May 2018
- First submitted
- 26 Feb 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Macdonald JA, Franҫois CJ, Forouzan O, Chesler NC, Wieben O. MRI assessment of aortic flow in patients with pulmonary arterial hypertension in response to exercise. BMC Med Imaging. 2018 Dec 22;18(1):55. doi: 10.1186/s12880-018-0298-9.
PubMed 30577768
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Pulmonary Vascular Interaction in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03523910
- Acronym / sponsor ID
- 2015-1526
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 25 Apr 2012 (actual)
- Primary completion
- 13 Feb 2017 (actual)
- Study completion
- 13 Feb 2017 (actual)
- First posted
- 14 May 2018 (actual)
- 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.
The goals of this study were two-fold. First, the attempt to quantify the relationships between pulmonary arterial stiffness, right ventricular function and the efficiency of ventricular-vascular interactions in patients with pulmonary arterial hypertension (PAH). Second, the attempt to quantify the effects of exercise on pulmonary arterial stiffness, pulmonary vascular resistance, right ventricular function and the efficiency of ventricular-vascular interactions in patients with PAH.
Detailed description
The goals of this study are to quantify right ventricular-pulmonary vascular interactions in different types of PAH, to determine the temporal changes in these interactions with PAH progression and to quantify the effects of exercise on right ventricular function. The inclusion of the subpopulation of PAH patients with systemic sclerosis (SSc) was a result of the anticipation that this group has worse arterial stiffening than other groups, and consequently more inefficient right ventricular-pulmonary vascular interactions, which account for their worse prognosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, open label, single-arm
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Device: Magnetic Resonance Imaging (MRI) with exerciseA research MRI scan with exercise will be obtained in conjunction with standard of care cardiopulmonary testing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of pulmonary arterial hypertension or a subtype
- Referred for right heart catheterization
- Age between 18 and 80 years
- New York Heart Association (NYHA) functional class I, II, or III
Key exclusion criteria (11 listed)
- Recent syncope (within 1 year)
- Severe skeletal or muscle abnormalities prohibiting exercise
- Mixed etiology pulmonary arterial hypertension
- Severe lung disease
- Pregnancy or breastfeeding
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) with exerciseAlso: MRIMRI scan with a novel exercise device. | Device | Patient |
Primary outcome
The primary outcome is to comprehensively quantify right ventricular and pulmonary vascular function at rest and with exercise using magnetic resonance imaging.
Time frame: Up to 24 months
The hypotheses will be tested by comprehensively quantifying ventricular and vascular function in subjects with idiopathic pulmonary arterial hypertension, systemic sclerosis pulmonary arterial hypertension, and chronic thromboembolic pulmonary hypertension, using investigational magnetic resonance angiography techniques.
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 May 2018.
- Derived from this study: PubMed 30577768Macdonald JA, Franҫois CJ, Forouzan O, Chesler NC, Wieben O. MRI assessment of aortic flow in patients with pulmonary arterial hypertension in response to exercise. BMC Med Imaging. 2018 Dec 22;18(1):55. doi: 10.1186/s12880-018-0298-9.
- Individual participant dataSharing planned: Undecided
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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.
Christopher Francois, MD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) with exercise in people with Pulmonary Arterial Hypertension (PAH), run by University of Wisconsin, Madison.
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 11 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 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The primary outcome is to comprehensively quantify right ventricular and pulmonary vascular function at rest and with exercise using magnetic resonance imaging. (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03523910, which also lists 1 linked publication.
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 May 2018.