Heart Failure-USB: Prediction and Progression

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Acute Coronary Syndrome; Acute Heart Failure
• Intervention / Treatment: Other: medical chart review; Other: data generated by direct IT export

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Christian Müller, Prof. Dr.; Phone Number: 0041 6132 86 549; Email: Christian.mueller@usb.ch
• Study Contact Backup: Name: Eleni Michou, MD; Phone Number: 0041 61 328 77 47; Email: eleni.michou@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Cardiology, University Hospital Basel
    • Contact: Christian Mueller, Prof. Dr.; Phone Number: +41 61 32 86 549; Email: Christian.mueller@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 review; 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; Other: data generated by direct IT export; data generated by direct IT export include Anthropometric data (age, sex, height, weight), Vital signs, Laboratory data
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 review; 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; Other: data generated by direct IT export; data generated by direct IT export include Anthropometric data (age, sex, height, weight), Vital signs, Laboratory data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Christian Müller, Prof. Dr., Cardiology University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Failure; Acute Coronary Syndrome
• Other Study ID Numbers: 2019-00956; me19Mueller

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No