NCT06785506

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Nov 2022Sep 2026

Study Start

First participant enrolled

November 25, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 21, 2025

Status Verified

January 1, 2025

Enrollment Period

3.8 years

First QC Date

July 15, 2024

Last Update Submit

January 20, 2025

Conditions

Heart Failure with Preserved Ejection FractionHeart Failure, DiastolicChronic Heart Failure

Keywords

HFpEFHeart failurepreserved ejection fractionbiomarkers

Outcome Measures

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.

    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 Outcomes (7)

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

    Every 6 months, up to 3,5 years

  • Number of patients with hospital readmission for acute or worsened HF

    Every 6 months, up to 3.5 years

  • Number of participants with cardiovascular death.

    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.

    Every 6 months, up to 3,5 years

  • Number of partcipants with all-cause death

    Every 6 months, up to 3,5 years

  • +2 more secondary outcomes

Study Arms (1)

Heart failure patients visiting the outpatient clinic

Heart failure patients visiting the outpatient clinic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • History of LVEF ≤40%
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Noordwest Ziekenhuisgroep

Alkmaar, North Holland, 1815JD, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

OLVG Ziekenhuis

Amsterdam, North Holland, 1091AC, Netherlands

RECRUITING

Franciscus Gasthuis & Vlietland Ziekenhuis

Rotterdam, South Holland, 3004BA, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Ikazia Ziekenhuis

Rotterdam, South Holland, 3083AN, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood (EDTA plasma, citrate plasma, serum) and urine samples are taken at the day of inclusion and at follow-up visits, which will be performed every 6 months, until the end of the scheduled follow-up, or until the patient dies. The maximum total number of samples per patient is 8 (in patients with 3.5 year follow-up).

MeSH Terms

Conditions

Heart Failure, DiastolicHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Isabella Kardys, Prof.

CONTACT

+31650032051i.kardys@erasmusmc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr., MD PhD

Study Record Dates

First Submitted

July 15, 2024

First Posted

January 21, 2025

Study Start

November 25, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 21, 2025

Record last verified: 2025-01

Locations

NL(6)