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

NCT04377854 | Recruiting DMC

• 1 other identifier: H-19055497
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Alive

  25 years from inclusion

• Dead

  Dead after inclusion in study

  25 years from inclusion

Study Arms (3)

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

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.

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.

Interventions

Observation. No intervention per se. OTHER

Observation. No intervention (no collection of blood).

Also known as: 1) Observation - No intervention

Recipient of cardiac transplant; Watchful waiting at Rigshospitalet

2) Observation and collection and of blood sample 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.

Also known as: Blood sample

MCS recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• No consent

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, DK, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Observation; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Central Study Contacts

Kiran Mirza, MD

CONTACT

+4535451442; KiranMirza@dadlnet.dk

Finn Gustafsson, MD, PhD, DMSci

CONTACT

+4535459743; Finn.Gustafsson@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 6, 2020
• Study Start: September 18, 2020
• Primary Completion (Estimated): August 1, 2045
• Study Completion (Estimated): August 1, 2045
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)