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出境医 / 临床实验 / Heart Failure-USB: Prediction and Progression
Heart Failure-USB: Prediction and Progression
Study Description
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
| 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 |
Arms 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.
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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
Primary Outcome Measures :
- 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
Eligibility Criteria
| 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
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 |
Locations
| 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
| Principal Investigator: | Christian Müller, Prof. Dr. | Cardiology University Hospital Basel |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 25, 2019 | ||||||||
| First Posted Date | June 27, 2019 | ||||||||
| Last Update Posted Date | February 8, 2021 | ||||||||
| 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 |
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| Original Primary Outcome Measures |
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| 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 |
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| 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 |
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
6000 | ||||||||
| Original Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | University Hospital, Basel, Switzerland | ||||||||
| Study Sponsor | University Hospital, Basel, Switzerland | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | University Hospital, Basel, Switzerland | ||||||||
| Verification Date | February 2021 | ||||||||
