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

Erasmus Medical Center200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, Netherlands

RECRUITING

OLVG Ziekenhuis

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

The primary endpoint is the number of participants with a combined endpoint of: urgent visit resulting in intravenous therapy for HF, hospital readmission for acute or worsened HF, and cardiovascular death.

This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient.

Time frame: Every 6 months, up to 3,5 years

Secondary Outcomes

Number of participants with urgent visit resulting in intravenous therapy for heart failure

Time frame: Every 6 months, up to 3,5 years

Number of patients with hospital readmission for acute or worsened HF

Time frame: Every 6 months, up to 3.5 years

Number of participants with cardiovascular death.

Time frame: Every 6 months, up to 3.5 years

Number of participants with the combined endpoint urgent visit resulting in intravenous therapy for HF, hospital readmission for acute or worsened HF, and all-cause death.

This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient.

Time frame: Every 6 months, up to 3,5 years

Number of partcipants with all-cause death

Time frame: Every 6 months, up to 3,5 years

Number of participants with the combined endpoint of myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG)

This is a composite endpoint; therefore, the first occurrence of any of the described components will result in the endpoint being met for an individual patient.

Central Contacts

Isabella Kardys, Prof.

CONTACT

+31650032051 i.kardys@erasmusmc.nl

Data from ClinicalTrials.gov

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