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

January 20, 2025 updated by: Isabella Kardys, Erasmus Medical Center

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Heart failure patients visiting the outpatient clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 6 months, up to 3,5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with urgent visit resulting in intravenous therapy for heart failure
Time Frame: Every 6 months, up to 3,5 years
Every 6 months, up to 3,5 years
Number of patients with hospital readmission for acute or worsened HF
Time Frame: Every 6 months, up to 3.5 years
Every 6 months, up to 3.5 years
Number of participants with cardiovascular death.
Time Frame: Every 6 months, up to 3.5 years
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.
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.
Every 6 months, up to 3,5 years
Number of partcipants with all-cause death
Time Frame: Every 6 months, up to 3,5 years
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)
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.
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)
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.
Every 6 months, up to 3,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Noordwest Ziekenhuisgroep
OLVG
Free University Medical Center
Ikazia Hospital, Rotterdam
Franciscus Gasthuis & Vlietland (Hospital)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC-2022-0408

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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