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

Last updated: January 20, 2025
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT06785506
MEC-2022-0408
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

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 ESCor/and a high (90%) probability of HFpEF according to the H2FPEF score, i.e. a scoreof 6 or higher.

Exclusion

Exclusion Criteria:

  • History of LVEF ≤40%

  • Scheduled for surgery or intervention for both coronary and non-coronary indicationwithin 6 months of inclusion

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

  • Acute or chronic liver disease, defined by serum levels of transaminases or alkalinephosphatase 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 Design

Total Participants: 200
Study Start date:
November 25, 2022
Estimated Completion Date:
September 01, 2026

Study 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.

Connect with a study center

  • Noordwest Ziekenhuisgroep

    Alkmaar, Noord-Holland 1815JD
    Netherlands

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam, Noord-Holland 1081HV
    Netherlands

    Active - Recruiting

  • OLVG Ziekenhuis

    Amsterdam, Noord-Holland 1091AC
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam, Zuid-Holland 3015GD
    Netherlands

    Active - Recruiting

  • Franciscus Gasthuis & Vlietland Ziekenhuis

    Rotterdam, Zuid-Holland 3004BA
    Netherlands

    Active - Recruiting

  • Ikazia Ziekenhuis

    Rotterdam, Zuid-Holland 3083AN
    Netherlands

    Active - Recruiting

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