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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

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Acute Heart Failure Acute Coronary Syndrome Heart Failure Other: medical chart review Other: data generated by direct IT export

Study Design
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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Heart Failure-USB: Prediction and Progression
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. number of cardiovascular death [ Time Frame: 1 to 8 years after hospitalization ]
    number of cardiovascular death in patients hospitalized with ACS and AHF

  4. number of cardiovascular hospitalizations [ Time Frame: 1 to 8 years after hospitalization ]
    number of cardiovascular hospitalizations


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000061


Contacts
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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

Locations
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Switzerland
Cardiology, University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Christian Mueller, Prof. Dr.    +41 61 32 86 549    Christian.mueller@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Christian Müller, Prof. Dr. Cardiology University Hospital Basel
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04000061    
Other Study ID Numbers: 2019-00956; me19Mueller
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Acute Coronary Syndrome
Heart Diseases
 Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases