Heart Failure-USB: Prediction and Progression

Heart Failure Clinical Trial

Official title:

Heart Failure-USB: Prediction and Progression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04000061
• Other study ID #: 2019-00956; me19Mueller
• Status: Recruiting
• Start date: June 13, 2019
• Est. completion date: July 2027

Study information

• Verified date: January 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Christian Müller, Prof. Dr.
• Phone: 0041 6132 86 549
• Email: Christian.mueller[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Heart Failure
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Switzerland	Cardiology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	number of cardiovascular death	number of cardiovascular death in patients hospitalized with ACS and AHF	1 to 8 years after hospitalization
Primary	number of cardiovascular hospitalizations	number of cardiovascular hospitalizations	1 to 8 years after hospitalization