RecruitingNCT06785506

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

A Dynamic, Multiple-biomarker Approach Aiming for Individualized Treatment of Heart Failure with Preserved Ejection Fraction (ADAPT-HFpEF)


Sponsor

Erasmus Medical Center

Enrollment

200 participants

Start Date

Nov 25, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria10

  • 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

Locations(6)

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

OLVG Ziekenhuis

Amsterdam, North Holland, Netherlands

Franciscus Gasthuis & Vlietland Ziekenhuis

Rotterdam, South Holland, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

Ikazia Ziekenhuis

Rotterdam, South Holland, Netherlands

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NCT06785506


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