Heart failure in patients with advanced chronic kidney disease Circulatory System Hypertensive heart and renal disease
Conditions
Interventions
This is an observational study of a cohort of patients with advanced chronic kidney disease.
The study will collect basic history, clinical assessment of heart failure (HF) symptoms, and use of the “
Sponsors
General University Hospital in Prague
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Treated by chronic hemodialysis in the collaborating haemodialysis units 2. Clinically stable 3. Willing to participate 4. ESKD treated by hemodialysis for at least 3 months 5. Aged >18 years
Exclusion criteria
Exclusion criteria: 1. Planned kidney transplantation from a living donor within 3 months of the index visit 2. Life expectancy <6 months at the index (first) visit for any reason 3. No dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 07/07/2021: 1. Incidence of cardiovascular death measured from patient notes between baseline and the end of the study 2. Worsening of heart failure (defined as worsening by 1 class of New York Heart Association Functional Classification, the incidence of hospitalization for de-compensation, an ejection fraction decrease by =10%, or new diagnosis of heart failure) measured using clinical assessment and patient notes every 6-12 months between baseline and the end of the study 3. Incidence of significant cardiovascular morbidity (acute coronary syndrome or stroke) measured from patient notes between baseline and the end of the study ______ Previous primary outcome measure: 1. Incidence of death measured from patient notes between baseline and the end of the study 2. Worsening of heart failure (defined as worsening by 1 class of New York Heart Association Functional Classification, the incidence of hospitalization for de-compensation, an ejection fraction decrease by =10%, or new diagnosis of heart failure) measured using clinical assessment and patient notes every 6-12 months between baseline and the end of the study 3. Incidence of significant cardiovascular morbidity (acute coronary syndrome or stroke) measured from patient notes between baseline and the end of the study 4. Coronary or valvular intervention (percutaneous or surgical) measured from patient notes between baseline and the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 07/07/2021: 1. Components of the primary endpoint measured from patient notes between baseline and the end of the study 2. Incidence of other cardiovascular morbidity (stroke, acute leg ischemia, pulmonary embolism, etc.) measured from patient notes between baseline and the end of the study 3. Need for dry weight decrease by >3% of body weight because of overhydration measured by body composition monitor every 6-12 months between baseline and the end of the study 4. Need of coronary or valvular intervention (percutaneous or surgical) measured from electrocardiography and echocardiography every 6-12 months between baseline and the end of the study 5. Incidence of pacemaker/defibrillator implantation measured from patient notes between baseline and the end of the study 6. Coronary or valvular intervention (percutaneous or surgical) measured from patient notes between baseline and the end of the study 7. Incidence of vascular access intervention measured from patient notes between baseline and the end of the study 8. Non-cardiac death measured from patients notes between baseline and the end of the study _____ Previous secondary outcome measures: 1. Components of the primary endpoint measured from patient notes between baseline and the end of the study 2. Incidence of other cardiovascular morbidity (stroke, acute leg ischemia, pulmonary embolism, etc.) measured from patient notes between baseline and the end of the study 3. Need for dry weight decrease by >3% of body weight because of overhydration measured by body composition monitor every 6-12 months between baseline and the end of the study 4. Need of coronary or valvular intervention (percutaneous or surgical) measured from electrocardiography and echocardiography every 6-12 months between baseline and the end of the study 5. Incidence of pacemaker/defibrillator implantation measured from patient notes between baseline and the end of the study 6. Incidence of vascular | — |
Countries
Czech Republic
Contacts
Public ContactAnna Valerianova
Outcome results
None listed