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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04654650
• Other study ID #: HHPHBiobank
• Status: Recruiting
• Start date: January 26, 2021
• Est. completion date: January 25, 2041

Study information

• Verified date: November 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Lars Harbaum, MD
• Phone: +4940741018337
• Email: l.harbaum[@]uke.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 25, 2041
• Est. primary completion date: January 25, 2041
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of pulmonary hypertension group 1 to 5

• Ability to give informed consent

Exclusion Criteria:

• Withdrawal of informed consent

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant-free survival		Up to 20 years of follow-up after enrollment
Secondary	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
Secondary	Registry to Evaluate Early And Long-term PAH Disease Management (REVEAL) 2.0 risk score		Up to 20 years of follow-up after enrollment