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

Recruiting

• Conditions: Pulmonary Hypertension

• Registration Number: NCT04654650
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

Prospective registry and biobank for long-term observational studies in adult patients with pulmonary hypertension

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 Timeline

• Study First Submitted: 2020-11-04
• Study First Submitted QC: 2020-11-29
• Study First Posted: 2020-12-04
• Study Start: 2021-01-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-20
• Primary Completion: 2041-01-25
• Study Completion: 2041-01-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

Exclusion Criteria

• Withdrawal of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transplant-free survival	Up to 20 years of follow-up after enrollment

Secondary Outcome Measures

Name	Time	Method
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	Up to 20 years of follow-up after enrollment
Registry to Evaluate Early And Long-term PAH Disease Management (REVEAL) 2.0 risk score	Up to 20 years of follow-up after enrollment

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany