NCT04000061

Brief Summary

This retrospective cohort study is to identify triggers of heart failure (HF) development and drivers of HF progression as well as the underlying cardiac disease (phenotype) to identify patients at risk and predict the clinical course of the disease. Data of patients who were hospitalized during the years 2010-2023 with acute coronary syndrome (ACS) and/ or with acute heart failure (AHF) will be collected and analyzed. In a subgroup cohort efficacy and safety of digoxin in patients with acute heart failure triggered by tachyarrhythmia will be evaluated.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Jun 2019Dec 2026

Study Start

First participant enrolled

June 13, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

7.6 years

First QC Date

June 25, 2019

Last Update Submit

April 9, 2025

Conditions

Acute Heart FailureAcute Coronary SyndromeHeart Failure

Outcome Measures

Primary Outcomes (4)

  • number of all-cause death

    number of all-cause death in patients hospitalized with ACS and AHF during the years 2010-2023.

    1 to 8 years after hospitalization

  • number of HF hospitalizations

    number of new HF hospitalizations in patients hospitalized with ACS and AHF during the years 2010-2023

    1 to 8 years after hospitalization

  • number of cardiovascular death

    number of cardiovascular death in patients hospitalized with ACS and AHF

    1 to 8 years after hospitalization

  • number of cardiovascular hospitalizations

    number of cardiovascular hospitalizations

    1 to 8 years after hospitalization

Study Arms (2)

acute coronary syndrome (ACS)

Outcome information (all-cause death, heart failure (HF) hospitalizations) of patients hospitalized with a primary diagnosis of ACS is analyzed.

Other: medical chart reviewOther: data generated by direct IT export

acute heart failure (AHF)

Outcome information (all-cause death, heart failure (HF) hospitalizations) of patients hospitalized with a primary or secondary diagnosis of AHF is analyzed.

Other: medical chart reviewOther: data generated by direct IT export

Interventions

medical chart reviewOTHER

data generated by medical review include Medical history, Medications at presentation, during hospitalization and at discharge, New York Heart Association (NYHA) class, Killip class, Electrocardiographic (ECG) data, echocardiographic data, Interventions (Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG), Implantable Cardioverter Defibrillator (ICD) implantation, Cardiac Resynchronization Therapy (CRT) Implantation), Outcome Information: all-cause death, HF hospitalizations

acute coronary syndrome (ACS)acute heart failure (AHF)
data generated by direct IT exportOTHER

data generated by direct IT export include Anthropometric data (age, sex, height, weight), Vital signs, Laboratory data

acute coronary syndrome (ACS)acute heart failure (AHF)

Eligibility Criteria

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

Patients that were hospitalized at the Universitätsspital Basel/ Switzerland with the diagnosis of ACS or AHF during the years 2010 - 2023

You may qualify if:

  • Patients hospitalized with a primary diagnosis of ACS
  • Patients hospitalized with a primary or secondary diagnosis of AHF

You may not qualify if:

  • Existence of a documented statement of the patient against the scientific use of clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeHeart Failure

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Christian Müller, Prof. Dr.

    Cardiology University Hospital Basel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Müller, Prof. Dr.

CONTACT

0041 6132 86 549Christian.mueller@usb.ch

Fiona Nafaa, MD

CONTACT

+41 61 32 87747fiona.nafaa@usb.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2019

First Posted

June 27, 2019

Study Start

June 13, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 10, 2025

Record last verified: 2025-04

Locations

CH(1)