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New Orleans Pulmonary Hypertension Biobank (NO-PH Biobank)

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ClinicalTrials.gov Identifier: NCT03269630
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans

Brief 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 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.

Condition or disease Intervention/treatment
Pulmonary Hypertension Systemic Sclerosis Mixed Connective Tissue Disease Heart Failure With Normal Ejection Fraction Healthy Other: No intervention. Biospecimen collection only

Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: New Orleans Pulmonary Hypertension Biobank
Actual Study Start Date : December 29, 2017
Estimated Primary Completion Date : October 2027
Estimated Study Completion Date : October 2027


Group/Cohort Intervention/treatment
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
Other: No intervention. Biospecimen collection only
Biospecimen collection

Outpatient right heart catheterization patients
-Outpatients undergoing right heart catheterization for any indication
Other: No intervention. Biospecimen collection only
Biospecimen collection

Healthy controls
  • Age>18
  • Not actively smoking
  • No chronic medical conditions
Other: No intervention. Biospecimen collection only
Biospecimen collection




Primary Outcome Measures :
  1. Collection of biospecimens [ Time Frame: 10 years ]
    Biospecimen collection only


Biospecimen Retention:   Samples With DNA
Blood (serum, plasma, buffy coat, PBMCs) Urine Stool


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age<18
  • Pregnant
  • Unable to understand English
  • Currently incarcerated
  • Unwilling or unable to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269630


Contacts
Contact: Matthew R Lammi, MD, MSCR 5045684634 mlammi@lsuhsc.edu

Locations
United States, Louisiana
University Medical Center-New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Matthew Lammi, MD, MSCR    504-568-4634    mlammi@lsuhsc.edu   
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans

Responsible Party: Matthew Lammi, Associate Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT03269630     History of Changes
Other Study ID Numbers: LSU
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A sharing plan will be developed to share biospecimens with interested researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Scleroderma, Systemic
Scleroderma, Diffuse
Heart Failure
Connective Tissue Diseases
Mixed Connective Tissue Disease
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Skin Diseases