Complex Pathophysiological Background of Heart Failure Deterioration
Multiparametric Assessment of Complex Pathophysiological Background of Heart Failure Deterioration - Relation to Treatment Effects and Prognosis
1 other identifier
observational
102
1 country
1
Brief Summary
Preventing heart failure (HF) deterioration is a great challenge for contemporary medicine. The progress course of HF is with increasing frequency of subsequent hospitalizations (approximately 30% of hospitalizations are the repeated ones). It is estimated that the costs of hospital stays constitute nearly 2/3 of healthcare costs provided for HF patients. The difficulty in treatment of patients with HF deterioration is associated with numerous comorbidities and coexisting complications (i.e. aggravation of ischaemic heart disease, lung diseases, infections, electrolyte disturbances, anaemia, renal failure as well as operations, in particular emergency ones). Our study is aimed to evaluation the complex pathophysiological background related to heart failure deterioration with respect to the effect of applied in-hospital treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 22, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedNovember 14, 2018
November 1, 2018
2.5 years
January 22, 2015
November 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
in-hospital death
time frame - assumed mean time of hospitalization
8 days
combined primary endpoint (in-hospital death and/or myocardial infract and/or stroke and/or serious arrhythmia and/or worsening renal function)
time frame - assumed mean time of hospitalization
8 days
Secondary Outcomes (4)
myocardial infract
8 days
stroke (clinical symptoms and confirmed in CT)
8 days
serious arrhythmia (new onset sustained ventricular tachycardia/fibrillation, supraventricular tachycardia, atrial fibrillation/flutter, sustained bradycardia <40/min)
8 days
worsening renal function (increase in creatinine 0,3mg/dl according to the definition of AKDI)
8 days
Other Outcomes (24)
significant electrolyte disturbances (K <3,0mmol/l; Na < 120mmol/l and or change in Na 10 mmol/l)
8 days
symptomatic hypotension (SBP <90 mmHg or change in40 mmHg)
8 days
hospitalization time (days)
8 days
- +21 more other outcomes
Eligibility Criteria
Patients with heart failure admitted to the Department of Internal Diseases and Cardiology urgently because of symptomatic heart failure deterioration
You may qualify if:
- patients of either sex
- urgent hospitalization caused by deterioration of HF.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Military Institute of Medicine
Warsaw, Masovian Voivodeship, 04-141, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pawel Krzesinski, MD, PhD
Military Institute of Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientific Assistant
Study Record Dates
First Submitted
January 22, 2015
First Posted
February 4, 2015
Study Start
December 1, 2014
Primary Completion
June 1, 2017
Study Completion
June 1, 2018
Last Updated
November 14, 2018
Record last verified: 2018-11