Clinical trial NCT06785506: Multiple-biomarker Approach for Individualized Treatment of Heart Failure with Preserved Ejection Fraction
Official title: A Dynamic, Multiple-biomarker Approach Aiming for Individualized Treatment of Heart Failure with Preserved Ejection Fraction (ADAPT-HFpEF)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure with Preserved Ejection Fraction
Heart Failure, Diastolic
Chronic Heart Failure
Keywords: HFpEF
Heart failure
preserved ejection fraction
biomarkers
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Ikazia Hospital, Rotterdam
name: Franciscus Gasthuis & Vlietland (Hospital)
name: OLVG
name: Free University Medical Center
name: Noordwest Ziekenhuisgroep
First posted: 2025-01-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a (suspected) diagnosis of HFpEF will be recruited through the Cardiology outpatient clinics of the Erasmus MC and five other hospitals.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Every 6 months, up to 3,5 years
Secondary outcomes:
measure: Number of participants with urgent visit resulting in intravenous therapy for heart failure
timeFrame: Every 6 months, up to 3,5 years
measure: Number of patients with hospital readmission for acute or worsened HF
timeFrame: Every 6 months, up to 3.5 years
measure: Number of participants with cardiovascular death.
timeFrame: Every 6 months, up to 3.5 years
measure: 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.
timeFrame: Every 6 months, up to 3,5 years
measure: Number of partcipants with all-cause death
timeFrame: Every 6 months, up to 3,5 years
measure: 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)
timeFrame: Every 6 months, up to 3,5 years
measure: Number of participants with cardiovascular disease (includes all of the above-mentioned components, except all-cause death)
timeFrame: Every 6 months, up to 3,5 years
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: OLVG Ziekenhuis
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland Ziekenhuis
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
state: Zuid-Holland
Study officials:
References: