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

NCT ID: NCT04377854

Last Updated: 2021-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-18

Study Completion Date

2045-08-01

Brief Summary

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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.

Detailed Description

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

Conditions

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Heart Failure Left Ventricular Assist Device Prognosis Durable Mechanical Support Device

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

2) Observation and collection and of blood sample

Intervention Type OTHER

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.

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.

Observation. No intervention per se.

Intervention Type OTHER

Observation. No intervention (no collection of blood).

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.

Observation. No intervention per se.

Intervention Type OTHER

Observation. No intervention (no collection of blood).

Interventions

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Observation. No intervention per se.

Observation. No intervention (no collection of blood).

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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1) Observation - No intervention Blood sample

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Finn Gustafsson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rigshospitalet

Copenhagen, DK, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Kiran Mirza, MD

Role: CONTACT

+4535451442

Finn Gustafsson, MD, PhD, DMSci

Role: CONTACT

+4535459743

Facility Contacts

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Kiran Mirza, MD

Role: primary

+4535451442

Finn Gustafsson, MD,PhD,DMSc.

Role: backup

+4535459743

Other Identifiers

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H-19055497

Identifier Type: -

Identifier Source: org_study_id

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