Multiple-biomarker Approach for Individualized Treatment of Heart Failure with Preserved Ejection Fraction (ADAPT-HFpEF)

Erasmus University

Status: Enrolling

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

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT06785506

MEC-2022-0408

Details and patient eligibility

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Heart failure patients visiting the outpatient clinic

Description:

Heart failure patients visiting the outpatient clinic