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RECRUITINGNCT06785506

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

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 ...

Lead sponsor: Erasmus Medical Center•6 locations•View source on ClinicalTrials.gov

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Contacts

Isabella Kardys, Prof.

CONTACT

+31650032051 i.kardys@erasmusmc.nl

Sponsors

Lead Sponsor

Erasmus Medical Center

Collaborators

Ikazia Hospital, Rotterdam
Franciscus Gasthuis & Vlietland (Hospital)
OLVG
Universitair Ziekenhuis Brussel
Noordwest Ziekenhuisgroep

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 21, 2025Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment200

Start dateNov 2022

Last updatedJan 21, 2025

Condition

Heart Failure with Preserved Ejection Fraction Heart Failure, Diastolic Chronic Heart Failure

Locations shown

Noordwest Ziekenhuisgroep

Alkmaar, North Holland

Amsterdam UMC

Amsterdam, North Holland

OLVG Ziekenhuis

Amsterdam, North Holland

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2025Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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