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Pulmonary Hypertension Biorepository and Registry (PHBR)

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ClinicalTrials.gov Identifier: NCT04808596
Recruitment Status : Recruiting
First Posted : March 22, 2021
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Description
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Brief Summary:
Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease.

Condition or disease
Pulmonary Hypertension Pulmonary Arterial Hypertension Pulmonary Hypertension Due to Left Heart Disease Pulmonary Hypertension, Primary Pulmonary Hypertension Due to Lung Diseases and Hypoxia Pulmonary Hypertension, Primary, 4 Pulmonary Hypertension, Primary, 2 Pulmonary Hypertension, Primary, 3 Chronic Thromboembolic Pulmonary Hypertension

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Pulmonary Hypertension Biorepository and Registry
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : July 31, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Establish a Biorepository [ Time Frame: From Enrollment to 6 Months ]
    Establish a collection of biospecimens from patients with pulmonary hypertension.

  3. Biospecimens Collection [ Time Frame: From Enrollment to 12 Months ]
    Correlate biospecimens to longitudinally collected individual patient data.

  4. Collaborate [ Time Frame: From Enrollment to 24 Months ]
    Provide biospecimens to researchers investigating pulmonary hypertension. Separate IRB approval will be needed for these studies.


Biospecimen Retention:   Samples With DNA
Future projects might include genetic testing on your samples. Genetic testing studies pieces of DNA called genes. The cells in your body contain deoxyribonucleic acid, or DNA for short. DNA is passed down from your parents. It carries the genes that determine how you look and how your body works and tells a genetic story about you. Differences in genes may help explain why a particular drug is effective and safe in some people, but not in others. Differences in genes also may explain why some people get certain diseases, but others do not. The genetic information may be important in guiding targeted treatments in the future.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Pulmonary Hypertension Group 1-5
Criteria

Inclusion Criteria:

  1. The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP)
  2. The participant has a diagnosis of pulmonary hypertension confirmed by right heart catheterization
  3. Patient is ≥ 18 years of age or older

Exclusion Criteria:

  1. Participant declines to participate (living patients only)
  2. Participant is unable to provide informed consent (living patients only)
Contacts and Locations
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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): NCT04808596


Contacts
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Contact: Luigi R Boccardi, BS 9135884022 lboccardi@kumc.edu

Locations
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United States, Kansas
The University of Kansas Medical Center Enrolling by invitation
Kansas City, Kansas, United States, 66160
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Luigi R Boccardi, BS    913-588-4022    lboccardi@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Leslie A Spikes, MD Assistant Professor of Medicine
More Information
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04808596    
Other Study ID Numbers: STUDY#00145817
First Posted: March 22, 2021    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Contact Luigi Boccardi to discuss accessing IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Heart Diseases
 Hypoxia
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory