- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04808596
Pulmonary Hypertension Biorepository and Registry (PHBR)
May 27, 2021 updated by: University of Kansas Medical Center
Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease.
Study Overview
Status
Recruiting
Conditions
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension
- Chronic Thromboembolic Pulmonary Hypertension
- Pulmonary Hypertension Due to Left Heart Disease
- Pulmonary Hypertension, Primary, 4
- Pulmonary Hypertension, Primary, 2
- Pulmonary Hypertension, Primary, 3
- Pulmonary Hypertension, Primary
- Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Detailed Description
The aim of this project will be to establish a broad and wide-ranging registry and biorepository of blood samples from patients with pulmonary hypertension, including all WHO groups I-V to be used for future research in these areas.
This will be both a retrospective and prospective project.
The registry and biorepository will be utilized to study and grow our knowledge of the cellular mechanisms and mediators of the disease and, in turn, contribute to advancements in treatment.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Luigi R Boccardi, BS
- Phone Number: 9135884022
- Email: lboccardi@kumc.edu
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Medical Center
-
Kansas City, Kansas, United States, 66160
- Enrolling by invitation
- The University of Kansas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pulmonary Hypertension Group 1-5
Description
Inclusion Criteria:
- The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP)
- The participant has a diagnosis of pulmonary hypertension confirmed by right heart catheterization
- Patient is ≥ 18 years of age or older
Exclusion Criteria:
- Participant declines to participate (living patients only)
- Participant is unable to provide informed consent (living patients only)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Collect Clinical Data
Time Frame: From Enrollment to 6 Months
|
Collect clinically obtained data from current and deceased patients with pulmonary hypertension to support research.
|
From Enrollment to 6 Months
|
Establish a Biorepository
Time Frame: From Enrollment to 6 Months
|
Establish a collection of biospecimens from patients with pulmonary hypertension.
|
From Enrollment to 6 Months
|
Biospecimens Collection
Time Frame: From Enrollment to 12 Months
|
Correlate biospecimens to longitudinally collected individual patient data.
|
From Enrollment to 12 Months
|
Collaborate
Time Frame: From Enrollment to 24 Months
|
Provide biospecimens to researchers investigating pulmonary hypertension.
Separate IRB approval will be needed for these studies.
|
From Enrollment to 24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leslie A Spikes, MD, Assistant Professor of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2020
Primary Completion (Anticipated)
December 31, 2025
Study Completion (Anticipated)
July 31, 2026
Study Registration Dates
First Submitted
March 17, 2021
First Submitted That Met QC Criteria
March 17, 2021
First Posted (Actual)
March 22, 2021
Study Record Updates
Last Update Posted (Actual)
June 1, 2021
Last Update Submitted That Met QC Criteria
May 27, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY#00145817
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Contact Luigi Boccardi to discuss accessing IPD.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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