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Recruiting NCT06785506

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

— Observational Heart Failure with Preserved Ejection Fraction Heart Failure, Diastolic Chronic Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Failure with Preserved Ejection Fraction, Heart Failure, Diastolic, Chronic Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Number of participants with urgent visit resulting in intravenous therapy for heart failure [Time frame: 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]
  • Number of participants with cardiovascular death. [Time frame: 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]
  • Number of partcipants with all-cause death [Time frame: 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]
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 6 centers
  • Noordwest Ziekenhuisgroep — Alkmaar
  • Amsterdam UMC — Amsterdam
  • OLVG Ziekenhuis — Amsterdam
  • Franciscus Gasthuis & Vlietland Ziekenhuis — Rotterdam
  • Erasmus MC — Rotterdam
  • Ikazia Ziekenhuis — Rotterdam

Identifiers

NCT: NCT06785506 · MEC-2022-0408

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗