NCT04654650

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
176mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Jan 2021Jan 2041

First Submitted

Initial submission to the registry

November 4, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 26, 2021

Completed
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2041

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2041

Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

20 years

First QC Date

November 4, 2020

Last Update Submit

December 16, 2024

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Transplant-free survival

    Up to 20 years of follow-up after enrollment

Secondary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- Withdrawal of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Lars Harbaum, MD

CONTACT

+4940741018337l.harbaum@uke.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

December 4, 2020

Study Start

January 26, 2021

Primary Completion (Estimated)

January 25, 2041

Study Completion (Estimated)

January 25, 2041

Last Updated

December 20, 2024

Record last verified: 2024-12

Locations

DE(1)