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Heart Failure-USB: Prediction and Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04000061
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date June 25, 2019
First Posted Date June 27, 2019
Last Update Posted Date April 12, 2022
Actual Study Start Date June 13, 2019
Estimated Primary Completion Date July 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 3, 2021)
  • number of all-cause death [ Time Frame: 1 to 8 years after hospitalization ]
    number of all-cause death in patients hospitalized with ACS and AHF during the years 2010-2023.
  • number of HF hospitalizations [ Time Frame: 1 to 8 years after hospitalization ]
    number of new HF hospitalizations in patients hospitalized with ACS and AHF during the years 2010-2023
  • number of cardiovascular death [ Time Frame: 1 to 8 years after hospitalization ]
    number of cardiovascular death in patients hospitalized with ACS and AHF
  • number of cardiovascular hospitalizations [ Time Frame: 1 to 8 years after hospitalization ]
    number of cardiovascular hospitalizations
Original Primary Outcome Measures
 (submitted: June 25, 2019)
  • number of all-cause death [ Time Frame: 1 to 8 years after hospitalization ]
    number of all-cause death in patients hospitalized with ACS and AHF during the years 2014-2018.
  • number of HF hospitalizations [ Time Frame: 1 to 8 years after hospitalization ]
    number of new HF hospitalizations in patients hospitalized with ACS and AHF during the years 2014-2018
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Heart Failure-USB: Prediction and Progression
Official Title Heart Failure-USB: Prediction and Progression
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Acute Heart Failure
  • Acute Coronary Syndrome
  • 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
  • Other: data generated by direct IT export
    data generated by direct IT export include Anthropometric data (age, sex, height, weight), Vital signs, Laboratory data
Study Groups/Cohorts
  • acute coronary syndrome (ACS)
    Outcome information (all-cause death, heart failure (HF) hospitalizations) of patients hospitalized with a primary diagnosis of ACS is analyzed.
    Interventions:
    • Other: medical chart review
    • Other: 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.
    Interventions:
    • Other: medical chart review
    • Other: data generated by direct IT export
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 3, 2021)		 6000
Original Estimated Enrollment
 (submitted: June 25, 2019)		 3000
Estimated Study Completion Date July 2027
Estimated Primary Completion Date July 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christian Müller, Prof. Dr. 0041 6132 86 549 Christian.mueller@usb.ch
Contact: Eleni Michou, MD 0041 61 328 77 47 eleni.michou@usb.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04000061
Other Study ID Numbers 2019-00956; me19Mueller
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party University Hospital, Basel, Switzerland
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Basel, Switzerland
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Christian Müller, Prof. Dr. Cardiology University Hospital Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date April 2022