Pulmonary Hypertension Biorepository and Registry

Pulmonary Hypertension Clinical Trial

— PHBR  

Official title:

Pulmonary Hypertension Biorepository and Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808596
• Other study ID #: STUDY#00145817
• Status: Recruiting
• Start date: August 10, 2020
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2021
• Source: University of Kansas Medical Center
• Contact: Luigi R Boccardi, BS
• Phone: 9135884022
• Email: lboccardi[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 31, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Familial Primary Pulmonary Hypertension
• Heart Diseases
• Hypertension
• Hypertension, Pulmonary
• Hypoxia
• Lung Diseases
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension
• Pulmonary Hypertension Due to Left Heart Disease
• Pulmonary Hypertension Due to Lung Diseases and Hypoxia
• Pulmonary Hypertension, Primary
• Pulmonary Hypertension, Primary, 2
• Pulmonary Hypertension, Primary, 3
• Pulmonary Hypertension, Primary, 4

Locations

Country	Name	City	State
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect Clinical Data	Collect clinically obtained data from current and deceased patients with pulmonary hypertension to support research.	From Enrollment to 6 Months
Primary	Establish a Biorepository	Establish a collection of biospecimens from patients with pulmonary hypertension.	From Enrollment to 6 Months
Primary	Biospecimens Collection	Correlate biospecimens to longitudinally collected individual patient data.	From Enrollment to 12 Months
Primary	Collaborate	Provide biospecimens to researchers investigating pulmonary hypertension. Separate IRB approval will be needed for these studies.	From Enrollment to 24 Months