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

Recruiting

• Conditions: Heart Failure; Durable Mechanical Support Device; Left Ventricular Assist Device; Prognosis
• Interventions: Other: Observation. No intervention per se.; Other: 2) Observation and collection and of blood sample

• Registration Number: NCT04377854
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-05-03
• Study First Submitted QC: 2020-05-03
• Study First Posted: 2020-05-06
• Study Start: 2020-09-18
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-05
• Primary Completion: 2045-08-01
• Study Completion: 2045-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• No consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recipient of cardiac transplant	Observation. No intervention per se.	All recipients of cardiac transplantation(s) will be followed up on a yearly basis with collection of clinical data for 25 years.
Watchful waiting at Rigshospitalet	Observation. No intervention per se.	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.
MCS recipients	2) Observation and collection and of blood sample	All recipients of durable MCS will be followed up on a yearly basis with collection of blood sample and clinical data for 25 years.

Primary Outcome Measures

Name	Time	Method
Dead	25 years from inclusion	Dead after inclusion in study
Alive	25 years from inclusion

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, DK, Denmark