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

Recruiting

• Conditions: Heart Failure with Preserved Ejection Fraction; Heart Failure, Diastolic; Chronic Heart Failure

• Registration Number: NCT06785506
• Lead Sponsor: Erasmus Medical Center

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2022-11-25
• Study First Submitted: 2024-07-15
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-21
• Last Update Posted: 2025-01-21
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Every 6 months, up to 3,5 years	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with urgent visit resulting in intravenous therapy for heart failure	Every 6 months, up to 3,5 years
Number of patients with hospital readmission for acute or worsened HF	Every 6 months, up to 3.5 years
Number of participants with cardiovascular death.	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.	Every 6 months, up to 3,5 years	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.
Number of partcipants with all-cause death	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)	Every 6 months, up to 3,5 years	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.
Number of participants with cardiovascular disease (includes all of the above-mentioned components, except all-cause death)	Every 6 months, up to 3,5 years	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.

Trial Locations

Locations (6)

Noordwest Ziekenhuisgroep; 🇳🇱 Alkmaar, Noord-Holland, Netherlands

Amsterdam UMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

OLVG Ziekenhuis; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Franciscus Gasthuis & Vlietland Ziekenhuis; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Ikazia Ziekenhuis; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands