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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04377854
• Other study ID #: H-19055497
• Status: Recruiting
• Start date: September 18, 2020
• Est. completion date: August 1, 2045

Study information

• Verified date: April 2021
• Source: Rigshospitalet, Denmark
• Contact: Kiran Mirza, MD
• Phone: +4535451442
• Email: KiranMirza[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 1, 2045
• Est. primary completion date: August 1, 2045
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Age>18 years

Exclusion Criteria:

• No consent

Related Conditions & MeSH terms

• Durable Mechanical Support Device
• Heart Failure
• Left Ventricular Assist Device
• Prognosis

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	DK

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alive		25 years from inclusion
Primary	Dead	Dead after inclusion in study	25 years from inclusion