Pulmonary HypertensionNO-PH BiobankNCT03269630
New Orleans Pulmonary Hypertension Biobank
An observational study of Pulmonary Hypertension and Systemic Sclerosis, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery pressure >=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes are still sub-optimal and further research is required into the pathobiology of the disease and development of biomarkers that can… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Systemic Sclerosis, Mixed Connective Tissue Disease
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2017to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be enrolled from 2 venues: 1) Comprehensive Pulmonary Hypertension Center clinic (pulmonary hypertension, systemic sclerosis without PH, mixed connective tissue disease without PH) and 2) Outpatient right heart catheterization lab. Healthy subjects (age>18, not currently smoking, no chronic medical conditions) will also be enrolled.
Who may be able to join
- Diagnosis of pulmonary hypertension and followed at the Comprehensive Pulmonary Hypertension Center OR
- Diagnosis of systemic sclerosis and followed at the Comprehensive Pulmonary Hypertension Center OR
- Diagnosis of mixed connective tissue disease and followed at the Comprehensive Pulmonary Hypertension Center OR
- Undergoing outpatient right heart catheterization
Who cannot join
- Age<18
- Pregnant
- Unable to understand English
- Currently incarcerated
- Unwilling or unable to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Medical Center-New Orleans
New Orleans, Louisiana, 70112
Matthew Lammi, MD, MSCR, 504-568-4634, mlammi@lsuhsc.edu
About this study
Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery pressure >=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes are still sub-optimal and further research is required into the pathobiology of the disease and development of biomarkers that can guide clinical care. The investigators are establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary hypertension, patients at high risk for pulmonary hypertension, healthy controls, and patients undergoing right heart catheterization. Specimens will be stored for future investigations.
- Conditions
- Pulmonary Hypertension, Systemic Sclerosis, Mixed Connective Tissue Disease, Heart Failure With Normal Ejection Fraction, Healthy
- Being tested
- No intervention. Biospecimen collection only
- Medical subject headings
- Hypertension, Pulmonary, Scleroderma, Systemic, Mixed Connective Tissue Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Biospecimen collection onlyOther
Biospecimen collection
| Study group | Role | What they receive |
|---|---|---|
| Clinic patients (Comprehensive Pulmonary Hypertension Center) | * Pulmonary hypertension patients (WHO group 1-5)
* Systemic sclerosis patients without pulmonary hypertension
* Mixed connective tissue disease patients without pulmonary hypertension Receives: Other: No intervention. Biospecimen collection only | |
| Outpatient right heart catheterization patients | -Outpatients undergoing right heart catheterization for any indication Receives: Other: No intervention. Biospecimen collection only | |
| Healthy controls | * Age>18
* Not actively smoking
* No chronic medical conditions Receives: Other: No intervention. Biospecimen collection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of biospecimens
Biospecimen collection only
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start29 Dec 2017
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269630
- Sponsor's protocol ID
- LSU
- Acronym
- NO-PH Biobank
- Status last verified
- Sep 2021
- First submitted
- 29 Aug 2017
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A sharing plan will be developed to share biospecimens with interested researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Orleans Pulmonary Hypertension Biobank
- ClinicalTrials.gov ID
- NCT03269630
- Acronym / sponsor ID
- NO-PH Biobank / LSU
- Conditions
- Pulmonary Hypertension, Systemic Sclerosis, Mixed Connective Tissue Disease, Heart Failure With Normal Ejection Fraction, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 Sep 2017 (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.
Pulmonary hypertension (PH) is a serious condition characterized by a mean pulmonary artery pressure >=25mmHg on right heart catheterization (RHC). Despite advances in PH care, outcomes are still sub-optimal and further research is required into the pathobiology of the disease and development of biomarkers that can guide clinical care. The investigators are establishing a biobank to collect samples (blood, urine, stool) from patients with pulmonary hypertension, patients at high risk for pulmonary hypertension, healthy controls, and patients undergoing right heart catheterization. Specimens will be stored for future investigations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinic patients (Comprehensive Pulmonary Hypertension Center) | – | Other: No intervention. Biospecimen collection only* Pulmonary hypertension patients (WHO group 1-5) * Systemic sclerosis patients without pulmonary hypertension * Mixed connective tissue disease patients without pulmonary hypertension |
| Outpatient right heart catheterization patients | – | Other: No intervention. Biospecimen collection only-Outpatients undergoing right heart catheterization for any indication |
| Healthy controls | – | Other: No intervention. Biospecimen collection only* Age>18 * Not actively smoking * No chronic medical conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be enrolled from 2 venues: 1) Comprehensive Pulmonary Hypertension Center clinic (pulmonary hypertension, systemic sclerosis without PH, mixed connective tissue disease without PH) and 2) Outpatient right heart catheterization lab. Healthy subjects (age>18, not currently smoking, no chronic medical conditions) will also be enrolled.
Key inclusion criteria (4 listed)
- Diagnosis of pulmonary hypertension and followed at the Comprehensive Pulmonary Hypertension Center OR
- Diagnosis of systemic sclerosis and followed at the Comprehensive Pulmonary Hypertension Center OR
- Diagnosis of mixed connective tissue disease and followed at the Comprehensive Pulmonary Hypertension Center OR
- Undergoing outpatient right heart catheterization
Key exclusion criteria (5 listed)
- Age<18
- Pregnant
- Unable to understand English
- Currently incarcerated
- Unwilling or unable to sign informed consent
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 |
|---|---|---|
| No intervention. Biospecimen collection onlyBiospecimen collection | Other | Clinic patients (Comprehensive Pulmonary Hypertension Center), Healthy controls, Outpatient right heart catheterization patients |
Primary outcome
Collection of biospecimens
Time frame: 10 years
Biospecimen collection only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: Yes. A sharing plan will be developed to share biospecimens with interested researchers.
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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.
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 Hypertension and Systemic Sclerosis, run by Louisiana State University Health Sciences Center in New Orleans 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew R Lammi, MD, MSCR (5045684634, mlammi@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of biospecimens (time frame: 10 years). 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 10 Sep 2021.