Multiple-biomarker Approach for Individualized Treatment of Heart Failure with Preserved Ejection Fraction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasmus Medical Center

About this trial

The primary objective is to investigate the association between temporal evolutions of blood biomarkers and clinical adverse events, in order to produce a dynamic, individual, and accurate prediction model for patients with HFpEF.

Moreover several secondary objectives will be investigated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age of 18 years or older

Capable of understanding and signing informed consent

A diagnosis of HFpEF according to the HFA-PEFF diagnostic algorithm of the ESC or/and a high (90%) probability of HFpEF according to the H2FPEF score, i.e. a score of 6 or higher.

Disqualifiers

History of LVEF ≤40%

Scheduled for surgery or intervention for both coronary and non-coronary indication within 6 months of inclusion

Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis at the time of screening

Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening

Trial population

Patients with a (suspected) diagnosis of HFpEF will be recruited through the Cardiology outpatient clinics of the Erasmus MC and five other hospitals.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Heart failure patients visiting the outpatient clinic

Trial outcomes

Primary outcomes

1

The primary endpoint is the number of participants with a combined endpoint of: urgent visit resulting in intravenous therapy for HF, hospital readmission for acute or worsened HF, and cardiovascular death.

This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient.

Time frame
Every 6 months, up to 3,5 years

Secondary outcomes

1

Number of participants with urgent visit resulting in intravenous therapy for heart failure

Time frame
Every 6 months, up to 3,5 years
2

Number of patients with hospital readmission for acute or worsened HF

Time frame
Every 6 months, up to 3.5 years
3

Number of participants with cardiovascular death.

Time frame
Every 6 months, up to 3.5 years
4

Number of participants with the combined endpoint urgent visit resulting in intravenous therapy for HF, hospital readmission for acute or worsened HF, and all-cause death.

This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient.

Time frame
Every 6 months, up to 3,5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Erasmus Medical Center

Lead sponsor

Ikazia Hospital, Rotterdam

Collaborator

Franciscus Gasthuis & Vlietland (Hospital)

Collaborator

OLVG

Collaborator

Universitair Ziekenhuis Brussel

Collaborator

Noordwest Ziekenhuisgroep

Collaborator