Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients with Pulmonary Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Transplant-free survival [Time frame: Up to 20 years of follow-up after enrollment]
Secondary outcome measures (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 [Time frame: Up to 20 years of follow-up after enrollment]
- 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]
Eligibility criteria
Inclusion criteria
- Diagnosis of pulmonary hypertension group 1 to 5
- Ability to give informed consent
Exclusion criteria
\- Withdrawal of informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Universitätsklinikum Hamburg-Eppendorf — Hamburg
Identifiers
NCT: NCT04654650 · HHPHBiobank