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

NCT ID: NCT06785506

Last Updated: 2025-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-25

Study Completion Date

2026-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart failure patients visiting the outpatient clinic

Heart failure patients visiting the outpatient clinic

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ikazia Hospital, Rotterdam

OTHER

Sponsor Role collaborator

Franciscus Gasthuis & Vlietland (Hospital)

OTHER

Sponsor Role collaborator

OLVG

NETWORK

Sponsor Role collaborator

Free University Medical Center

OTHER

Sponsor Role collaborator

Noordwest Ziekenhuisgroep

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Isabella Kardys

Prof. dr., MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Noordwest Ziekenhuisgroep

Alkmaar, North Holland, Netherlands

Site Status RECRUITING

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

OLVG Ziekenhuis

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Franciscus Gasthuis & Vlietland Ziekenhuis

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Erasmus MC

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Ikazia Ziekenhuis

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Isabella Kardys, Prof.

Role: CONTACT

+31650032051

Facility Contacts

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Sanneke de Boer, Dr

Role: primary

Mylene Loncq de Jong, MD

Role: backup

Louis L Handoko, Dr.

Role: primary

Mylene M Loncq de Jong, MD

Role: backup

Loek L van Heerebeek, Dr.

Role: primary

Mylene Loncq de Jong, MD

Role: backup

Bas van Dalen, Dr.

Role: primary

Suzie Tiebout, BSc

Role: backup

Isabella Kardys, Professor

Role: primary

+31650032051

Jasper Brugts, Professor

Role: backup

Mireille Emans, Dr.

Role: primary

Jose De Mira, MD

Role: backup

Other Identifiers

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MEC-2022-0408

Identifier Type: -

Identifier Source: org_study_id

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