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Prognostic Value of BNP in MCS - a 25 Year Follow up Study

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT04377854
Collaborator
(none)
1,000
Enrollment
1
Location
298.4
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observation. No intervention per se.
  • Other: 2) Observation and collection and of blood sample

Detailed Description

All patients referred for advanced HF treatment at the Dept of Cardiology at Rigshospitalet.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Prognostic Value of proBNP in Patients Supported With Durable Mechanical Circulatory Assist Devices - a 25 Year Follow up Study.
Actual Study Start Date :
Sep 18, 2020
Anticipated Primary Completion Date :
Aug 1, 2045
Anticipated Study Completion Date :
Aug 1, 2045

Arms and Interventions

Arm Intervention/Treatment
MCS recipients

All recipients of durable MCS will be followed up on a yearly basis with collection of blood sample and clinical data for 25 years.

Other: 2) Observation and collection and of blood sample
All 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.
Other Names:
  • Blood sample

    		•
    Recipient of cardiac transplant

    All recipients of cardiac transplantation(s) will be followed up on a yearly basis with collection of clinical data for 25 years.

    Other: Observation. No intervention per se.
    Observation. No intervention (no collection of blood).
    Other Names:
  • 1) Observation - No intervention

    		•
    Watchful waiting at Rigshospitalet

    Patients referred for evaluation for treatment with advanced treatment (LVAD/HTX) but -for whatever reason- these pts will be on watchful waiting at the Rigshospitalet.

    Other: Observation. No intervention per se.
    Observation. No intervention (no collection of blood).
    Other Names:
  • 1) Observation - No intervention

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Alive [25 years from inclusion]

    2. Dead [25 years from inclusion]

      Dead after inclusion in study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • All patients referred for evaluation for advanced HF treatment at the Rigshospital in Denmark

    • Age>18 years

    Exclusion Criteria:
    • No consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet Copenhagen DK Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Finn Gustafsson, Professor, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT04377854
    Other Study ID Numbers:
    • H-19055497
    First Posted:
    May 6, 2020
    Last Update Posted:
    May 5, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of May 5, 2021