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NCT Number: NCT06785506

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

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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction Cardiovascular Diseases Chronic Heart Failure Heart Diseases Heart Failure Heart Failure, Diastolic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Noordwest Ziekenhuisgroep, Alkmaar, North Holland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

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

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

  2. Number of patients with hospital readmission for acute or worsened HF

    Time frame: Every 6 months, up to 3.5 years

  3. Number of participants with cardiovascular death.

    Time frame: Every 6 months, up to 3.5 years

  4. 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.

    Time frame: 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.

  5. Number of partcipants with all-cause death

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

  6. 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)

    Time frame: 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.

  7. Number of participants with cardiovascular disease (includes all of the above-mentioned components, except all-cause death)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Isabella Kardys, Prof.

CONTACT

[email protected]

+31650032051

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Franciscus Gasthuis & Vlietland (Hospital)
  • Ikazia Hospital, Rotterdam
  • Noordwest Ziekenhuisgroep
  • OLVG
  • Universitair Ziekenhuis Brussel

Registry information

Official study title

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

Acronym: ADAPT-HFpEF

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2025
Registry last updated
Jan 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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