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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04654650

Enrollment

5000

Registered

2020-12-04

Start date

2021-01-26

Completion date

2041-01-25

Last updated

2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- Withdrawal of informed consent

Design outcomes

Primary

Measure	Time frame
Transplant-free survival	Up to 20 years of follow-up after enrollment

Secondary

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	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

Countries

Germany

Contacts

Primary ContactLars Harbaum, MD

l.harbaum@uke.de+4940741018337

Outcome results