Pulmonary Hypertension Biorepository and Registry

Study Purpose

Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04808596
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Kansas Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Leslie A Spikes, MD
Principal Investigator Affiliation Assistant Professor of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

The University of Kansas Medical Center, Kansas City, Kansas

Status

Enrolling by invitation

Address

The University of Kansas Medical Center

Kansas City, Kansas, 66160

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Luigi R Boccardi, BS

lboccardi@kumc.edu

913-588-4022

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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