Pulmonary Arterial HypertensionNCT01959815
Novel Screening Strategies for Scleroderma PAH
An observational study of Pulmonary Arterial Hypertension and Scleroderma, run by University of Michigan at 1 site in United States.
Trial summary
Patients with scleroderma can develop heart failure due to high blood pressure in the lungs (a condition called pulmonary arterial hypertension). It is important to find pulmonary arterial hypertension early, so that it can be treated before heart failure develops. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension, Scleroderma
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2013to 6 Nov 2019
- Phase
- Observational
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers will be recruited from scleroderma clinics, pulmonary hypertension clinics, and (for healthy volunteers) the Ann Arbor area.
Who may be able to join
- 30 years or older;
- diagnosis of limited or diffuse scleroderma (American College of Rheumatology criteria)
- for the "high risk" group, one of the following features:
- resting transthoracic echocardiogram showing elevated right-sided pressures within previous 3 months [tricuspid regurgitation (TR) jet >2.8 m/s or evidence of right ventricular dysfunction]
- pulmonary function testing (PFT) showing abnormal diffusing capacity of carbon monoxide (DLCO) not due to significant interstitial lung disease (DLCO<60% predicted or FVC: DLCO ratio >1.4)
Who cannot join
- Pregnancy
- prior diagnosis of pulmonary hypertension
- treatment with endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin analogues
- previous diagnosis of obstructive lung disease or pulmonary thromboembolic disease
- current smoker
- significant valvular disease
Show all 9Show fewer
- resting echocardiogram showing left ventricular ejection fraction<50% within previous 3 months
- resting echocardiogram showing significant (greater than Grade I) diastolic dysfunction
- pulmonary emboli (past or present).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Screening Strategies for Scleroderma PAH (Pulmonary Arterial Hypertension)
Patients with scleroderma can develop heart failure due to high blood pressure in the lungs (a condition called pulmonary arterial hypertension). It is important to find pulmonary arterial hypertension early, so that it can be treated before heart failure develops. However, the tests that we now use to find the earliest form of this disease in scleroderma patients are not good enough. This study will examine whether tests performed during exercise can improve our ability to find early pulmonary arterial hypertension. The study will also try to identify genes that are responsible for the development of pulmonary arterial hypertension.
- Conditions
- Pulmonary Arterial Hypertension, Scleroderma
- Medical subject headings
- Pulmonary Arterial Hypertension, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Scleroderma and diagnosed PAH | Not described | |
| "Low risk" scleroderma | Not described | |
| Healthy volunteers | Not described | |
| "High risk" scleroderma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of pulmonary arterial hypertension
Measured: Two years after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study start26 Sep 2013
- Primary completion6 Nov 2019
- Study completion6 Nov 2019
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 University of MichiganThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Visovatti, MD, University of Michigan
- Investigators
- Scott H Visovatti, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959815
- Sponsor's protocol ID
- HUM00074818
- Status last verified
- Nov 2021
- First submitted
- 8 Oct 2013
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Screening Strategies for Scleroderma PAH (Pulmonary Arterial Hypertension)
- ClinicalTrials.gov ID
- NCT01959815
- Acronym / sponsor ID
- HUM00074818
- Conditions
- Pulmonary Arterial Hypertension, Scleroderma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 26 Sep 2013 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 6 Nov 2019 (actual)
- First posted
- 10 Oct 2013 (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.
Patients with scleroderma can develop heart failure due to high blood pressure in the lungs (a condition called pulmonary arterial hypertension). It is important to find pulmonary arterial hypertension early, so that it can be treated before heart failure develops. However, the tests that we now use to find the earliest form of this disease in scleroderma patients are not good enough. This study will examine whether tests performed during exercise can improve our ability to find early pulmonary arterial hypertension. The study will also try to identify genes that are responsible for the development of pulmonary arterial hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Scleroderma and diagnosed PAH | – | – |
| "Low risk" scleroderma | – | – |
| Healthy volunteers | – | – |
| "High risk" scleroderma | – | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers will be recruited from scleroderma clinics, pulmonary hypertension clinics, and (for healthy volunteers) the Ann Arbor area.
Key inclusion criteria (5 listed)
- 30 years or older;
- diagnosis of limited or diffuse scleroderma (American College of Rheumatology criteria)
- for the "high risk" group, one of the following features:
Key exclusion criteria (9 listed)
- Pregnancy
- prior diagnosis of pulmonary hypertension
- treatment with endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin analogues
- previous diagnosis of obstructive lung disease or pulmonary thromboembolic disease
- current smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of pulmonary arterial hypertension
Time frame: Two years after enrollment.
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 15 Nov 2021.
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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.
Scott H Visovatti, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension and Scleroderma, run by University of Michigan at 1 site in United States.
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 9 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 15 Nov 2021. 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 United States. 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?
Development of pulmonary arterial hypertension (time frame: Two years after enrollment.). 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 15 Nov 2021.