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RecruitingNCT04654650Updated Dec 20, 2024

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

An observational study in Pulmonary Hypertension, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational

From the registry’s dates

  • Started Jan 2021; still recruiting 5 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pulmonary Hypertension
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Withdrawal of informed consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
20 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Transplant-free survival

    Time frame: Up to 20 years of follow-up after enrollment

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
  • Universitätsklinikum Hamburg-Eppendorf
    Hamburg, 20246, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04654650
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Responsible party
Sponsor
First posted
Dec 4, 2020
Start date
Jan 26, 2021
Primary completion
Jan 25, 2041 (estimated)
Completion
Jan 25, 2041 (estimated)
Last update
Dec 20, 2024

Study contacts

Lars Harbaum, MD
Contact
l.harbaum@uke.de
+4940741018337

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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