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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02355769 |
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Date of registration:
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22/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Complex Pathophysiological Background of Heart Failure Deterioration
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Scientific title:
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Multiparametric Assessment of Complex Pathophysiological Background of Heart Failure Deterioration - Relation to Treatment Effects and Prognosis |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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102 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02355769 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Poland
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Contacts
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Name:
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Pawel Krzesinski, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Military Institute of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients of either sex
- urgent hospitalization caused by deterioration of HF.
Exclusion Criteria:
- unstable coronary artery disease including myocardial infarct within the last 40 days
prior to recruitment
- stroke within 40 days prior to recruitment
- cardiac surgery within 90 days prior to recruitment
- pulmonary embolism
- severe pulmonary diseases (chronic obstructive pulmonary diseases - stage C/D,
uncontrolled asthma, pulmonary hypertension)
- chronic kidney disease (stage 5 and requiring dialysis)
- severe inflammatory disease
- severe mental and physical disorders
- patients' refusal to participate
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Primary Outcome(s)
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combined primary endpoint (in-hospital death and/or myocardial infract and/or stroke and/or serious arrhythmia and/or worsening renal function)
[Time Frame: 8 days]
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in-hospital death
[Time Frame: 8 days]
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Secondary Outcome(s)
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serious arrhythmia (new onset sustained ventricular tachycardia/fibrillation, supraventricular tachycardia, atrial fibrillation/flutter, sustained bradycardia <40/min)
[Time Frame: 8 days]
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myocardial infract
[Time Frame: 8 days]
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stroke (clinical symptoms and confirmed in CT)
[Time Frame: 8 days]
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worsening renal function (increase in creatinine 0,3mg/dl according to the definition of AKDI)
[Time Frame: 8 days]
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Secondary ID(s)
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WIM-0000000213
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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