NCT06469814

Brief Summary

The goal of this observational study is to provide a better understanding of medical practice for heart failure management based on real-world data, collected both across Europe and the rest of the world, using robust methodology and representativeness within each country. Standard management of patients will be the diagnostic and therapeutic interventions routinely performed in each center for patients presenting with signs and symptoms of chronic/acute heart failure.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

June 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

June 17, 2024

Last Update Submit

June 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adherence to ESC Guidelines in Heart Failure 2021

    Full adherence to guidelines for heart failure management

    12 months per site

Study Arms (2)

Patients with chronic heart failure

Patients with acute heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is all consenting patients seen in the outpatient clinic for chronic HF and all consenting patients admitted for acute HF in the study center as their standard medical care.

You may qualify if:

  • Adult patients with chronic or acute Heart Failure (HF), regardless of ejection fraction, either:
  • Outpatient with chronic HF (including first-time diagnosis), according to the clinical judgment.
  • Patients admitted to hospital or presenting to Emergency Department or Acute out-patient care for acute HF for whom an IV (diuretics, inotropes, vasodilators) or mechanical therapy for HF (mechanical circulatory support) is administered.

You may not qualify if:

  • Age \<18 years
  • Patients unwilling to consent (or patient's legally authorized representative unwilling to consent, if the patient is unable to consent).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Ovidiu Chioncel

    Institute for Cardiovascular Diseases C.C. Iliescu, Bucaresti, Romania

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 24, 2024

Study Start

September 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share