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

April 29, 2021 updated by: Finn Gustafsson, Rigshospitalet, Denmark

The Prognostic Value of proBNP in Patients Supported With Durable Mechanical Circulatory Assist Devices - a 25 Year Follow up Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • DK
      • Copenhagen, DK, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • All patients referred for evaluation for advanced HF treatment at the Rigshospital in Denmark
  • Age>18 years

Exclusion Criteria:

  • No consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alive
Time Frame: 25 years from inclusion
25 years from inclusion
Dead
Time Frame: 25 years from inclusion
Dead after inclusion in study
25 years from inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 18, 2020

Primary Completion (ANTICIPATED)

August 1, 2045

Study Completion (ANTICIPATED)

August 1, 2045

Study Registration Dates

First Submitted

May 3, 2020

First Submitted That Met QC Criteria

May 3, 2020

First Posted (ACTUAL)

May 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19055497

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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