Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients with Pulmonary Hypertension

December 16, 2024 updated by: Universitätsklinikum Hamburg-Eppendorf
Prospective registry and biobank for long-term observational studies in adult patients with pulmonary hypertension

Study Overview

Status

Recruiting

Conditions

Detailed Description

In a prospective registry prevalent and incident patients diagnosed with group 1 to 5 pulmonary hypertension will be enrolled. In an integrated biobank body fluid samples will be collected at enrollment and sequentially during treatment with targeted drugs for pulmonary hypertension.

Study Type

Observational

Enrollment (Estimated)

5000

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

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
        • Contact:

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

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with pulmonary hypertension and patients referred to a pulmonary hypertension center for suspected pulmonary hypertension.

Description

Inclusion Criteria:

  • Diagnosis of pulmonary hypertension group 1 to 5
  • Ability to give informed consent

Exclusion Criteria:

- Withdrawal of informed consent

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
Time Frame
Transplant-free survival
Time Frame: Up to 20 years of follow-up after enrollment
Up to 20 years of follow-up after enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Risk score (averaging low, intermediate and high risk categories) as proposed by the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for pulmonary hypertension
Time Frame: Up to 20 years of follow-up after enrollment
Up to 20 years of follow-up after enrollment
Registry to Evaluate Early And Long-term PAH Disease Management (REVEAL) 2.0 risk score
Time Frame: Up to 20 years of follow-up after enrollment
Up to 20 years of follow-up after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

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)

January 26, 2021

Primary Completion (Estimated)

January 25, 2041

Study Completion (Estimated)

January 25, 2041

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 29, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHPHBiobank

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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