Actively Recruiting

Age: 18Years +
All Genders
NCT06785506

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

Led by Erasmus Medical Center · Updated on 2025-01-21

200

Participants Needed

6

Research Sites

196 weeks

Total Duration

On this page

Sponsors

E

Erasmus Medical Center

Lead Sponsor

I

Ikazia Hospital, Rotterdam

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age of 18 years or older
  • Capable of understanding and signing informed consent
  • Diagnosis of HFpEF according to the HFA-PEFF diagnostic algorithm of the ESC or a high (90%) probability of HFpEF according to the H2FPEF score (score of 6 or higher)
Not Eligible

You will not qualify if you...

  • History of left ventricular ejection fraction (LVEF) 40% or lower
  • Scheduled for surgery or intervention for coronary or non-coronary indications within 6 months of inclusion
  • Impaired renal function defined as eGFR less than 20 mL/min/1.73 m2 or requiring dialysis at screening
  • Acute or chronic liver disease with serum transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
  • COPD Gold stage IV
  • Congenital heart disease
  • Pregnancy
  • Coexisting condition with life expectancy less than 1 year
  • Unlikely to attend all scheduled follow-up visits
  • Linguistic barrier

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, Netherlands, 1815JD

Actively Recruiting

2

Amsterdam UMC

Amsterdam, North Holland, Netherlands, 1081HV

Actively Recruiting

3

OLVG Ziekenhuis

Amsterdam, North Holland, Netherlands, 1091AC

Actively Recruiting

4

Franciscus Gasthuis & Vlietland Ziekenhuis

Rotterdam, South Holland, Netherlands, 3004BA

Actively Recruiting

5

Erasmus MC

Rotterdam, South Holland, Netherlands, 3015GD

Actively Recruiting

6

Ikazia Ziekenhuis

Rotterdam, South Holland, Netherlands, 3083AN

Actively Recruiting

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Research Team

I

Isabella Kardys, Prof.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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