Prognostic Value of BNP in MCS - a 25 Year Follow up Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
A biobank has been created to investigate the prognostic value of biomarkers (mainly BNP) in patients implanted with durable mechanical assist devices comparing patients with advanced HF supported by MCS with those who are transplanted and those who remain on optimal medical therapy.
Patients will be followed up for 25 years after inclusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients referred for evaluation for advanced HF treatment at the Rigshospital in Denmark
Age>18 years
Disqualifiers
No consent
Trial population
All patients referred for evaluation for advanced HF treatment at the Rigshospitalet in Denmark. All patients with Advanced HF (regardless of type of adv HF treatment) at the contributing center will (hopefully) be included in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observation. No intervention per se.
Other interventionObservation. No intervention (no collection of blood).
2) Observation and collection and of blood sample
Other interventionAll patients evaluated for adv HF (HTX/LVAD) will be offered to contribute to this database; Blood samples will be collected from all at baseline. Patients receiving LVAD will contribute on a yearly basis (or until withdrawal of consent). For other patients no further blood will be collected unless they receive an LVAD at a later point.
Treatment groups
1,000 Participants
are divided into 3 treatment groupsGroup A: MCS recipients1 intervention
Group B: Recipient of cardiac transplant1 intervention
Group C: Watchful waiting at Rigshospitalet1 intervention
Trial outcomes
Primary outcomes
1
Alive
Time frame
25 years from inclusion2
Dead
Dead after inclusion in study
Time frame
25 years from inclusionSponsors and contacts
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Source ClinicalTrials.gov