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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

This is a prospective, observational multi-center cohort study which will be conducted at the cardiology departments of the Erasmus Medical Centre (EMC) as well as five other hospitals. A total of 200 HFpEF patients will be included in the study via the outpatient clinics. The follow-up period will constitute a minimum of 2 years and a maximum of 3.5 years. Clinical data will be collected at baseline and blood samples will be collected at baseline and subsequently every 6 months.

Eligibility

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • COPD Gold stage IV
  • Congenital heart disease
  • Pregnancy
  • Coexistent condition with life expectancy of <1 year
  • Unlikely to appear at all scheduled follow-up visits
  • Linguistic barrier

Study details
    Heart Failure with Preserved Ejection Fraction
    Heart Failure
    Diastolic
    Chronic Heart Failure

NCT06785506

Erasmus Medical Center

15 October 2025

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