Heart Failure With Preserved Ejection FractionADAPT-HFpEFNCT06785506
Multiple-biomarker Approach for Individualized Treatment of Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction and Heart Failure, Diastolic, run by Erasmus Medical Center at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Heart Failure, Diastolic, Chronic Heart Failure
- How many people
- 200 participants
- Where
- 6 sitesNetherlands
- Study dates
- 25 Nov 2022to 1 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
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- Pregnancy
- Coexistent condition with life expectancy of <1 year
- Unlikely to appear at all scheduled follow-up visits
- Linguistic barrier
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Noordwest Ziekenhuisgroep
Alkmaar, North Holland, 1815JD
Amsterdam UMC
Amsterdam, North Holland, 1081HV
OLVG Ziekenhuis
Amsterdam, North Holland, 1091AC
Franciscus Gasthuis & Vlietland Ziekenhuis
Rotterdam, South Holland, 3004BA
Erasmus MC
Rotterdam, South Holland, 3015GD
Ikazia Ziekenhuis
Rotterdam, South Holland, 3083AN
About this study
Official title: A Dynamic, Multiple-biomarker Approach Aiming for Individualized Treatment of Heart Failure With Preserved Ejection Fraction (ADAPT-HFpEF)
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.
Read the 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.
- Conditions
- Heart Failure With Preserved Ejection Fraction, Heart Failure, Diastolic, Chronic Heart Failure
- Keywords
- HFpEF, Heart failure, preserved ejection fraction, biomarkers
- Medical subject headings
- Heart Failure, Diastolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients visiting the outpatient clinic | Heart failure patients visiting the outpatient clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 6 months, up to 3,5 years
Secondary outcomes (7)
Number of participants with urgent visit resulting in intravenous therapy for heart failure
Measured: Every 6 months, up to 3,5 years
Number of patients with hospital readmission for acute or worsened HF
Measured: Every 6 months, up to 3.5 years
Number of participants with cardiovascular death.
Measured: 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.
Measured: Every 6 months, up to 3,5 years
Number of partcipants with all-cause death
Measured: 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.
Measured: Every 6 months, up to 3,5 years
Number of participants with cardiovascular disease (includes all of the above-mentioned components, except 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.
Measured: Every 6 months, up to 3,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start25 Nov 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ikazia Hospital, Rotterdam, Franciscus Gasthuis & Vlietland (Hospital), OLVG, Universitair Ziekenhuis Brussel, Noordwest Ziekenhuisgroep
- Responsible party
- Principal investigator, Isabella Kardys, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785506
- Sponsor's protocol ID
- MEC-2022-0408
- Acronym
- ADAPT-HFpEF
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No