Heart failure with reduced ejection fraction
Conditions
Brief summary
Composite outcome (time-to-first event’ occurrence during the 6 months of follow-up): Symptomatic hypotension; Hyperkalaemia; Hypokalemia; eGFR drop ≥50% from baseline; or eGFR <15 ml/min/1.73m2 or renal transplant or dialysis; Increase in diuretic dose due to worsening HF; Use of intravenous diuretics for worsening HF; HF hospitalization; Death from CV causes
Detailed description
Symptomatic hypotension (systolic blood pressure <100 mmHg with signs or symptoms compatible with hypoperfusion), Hyperkalaemia (serum potassium >6.0 mmol/L), Hypokalemia (serum potassium <3.0 mmol/L), eGFR drop ≥50% from baseline; or eGFR <15 ml/min/1.73m2 or renal transplant or dialysis, Increase in diuretic dose due to worsening heart failure, Use of intravenous diuretics for worsening heart failure, Heart failure hospitalization, Death from cardiovascular causes, NT-pro BNP or BNP (log), High sensitivity C-reactive protein, Atrial fibrillation/flutter, Systolic and diastolic blood pressure, High sensitivity Troponin, Left atrial volume, Left ventricular (LV) systolic and diastolic volume, LV mass, LV ejection fraction, Pulmonary artery systolic pressure, Serum sodium, Serum potassium, Creatinine and glomerular filtration rate, Urinary sodium and potassium and albuminuria, Total Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides, Glucose and HbA1C, Uric acid, TSH and free T4, ALT, AST, Gamma-GT, Alkaline Phosphatase, Bilirubin, Iron, Ferritin and Sat. transferrin, Functional class (NYHA, New York Heart Association), Quality of life (KCCQ, Kansas City Cardiomyopathy Questionnaire), Dosage titration of sacubitril/valsartan up to the dose 97/103 mg (b.i.d.) at 3 months
Interventions
DRUGLINAGLIPTIN AND EMPAGLIFLOZIN
DRUGEMPAGLIFLOZIN
DRUGMETFORMIN AND DAPAGLIFLOZIN
DRUGDAPAGLIFLOZIN
DRUGSAXAGLIPTIN AND DAPAGLIFLOZIN
DRUGMETFORMIN AND EMPAGLIFLOZIN
Sponsors
University Of Porto, University Of Porto
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome (time-to-first event’ occurrence during the 6 months of follow-up): Symptomatic hypotension; Hyperkalaemia; Hypokalemia; eGFR drop ≥50% from baseline; or eGFR <15 ml/min/1.73m2 or renal transplant or dialysis; Increase in diuretic dose due to worsening HF; Use of intravenous diuretics for worsening HF; HF hospitalization; Death from CV causes | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptomatic hypotension (systolic blood pressure <100 mmHg with signs or symptoms compatible with hypoperfusion), Hyperkalaemia (serum potassium >6.0 mmol/L), Hypokalemia (serum potassium <3.0 mmol/L), eGFR drop ≥50% from baseline; or eGFR <15 ml/min/1.73m2 or renal transplant or dialysis, Increase in diuretic dose due to worsening heart failure, Use of intravenous diuretics for worsening heart failure, Heart failure hospitalization, Death from cardiovascular causes, NT-pro BNP or BNP (log), High sensitivity C-reactive protein, Atrial fibrillation/flutter, Systolic and diastolic blood pressure, High sensitivity Troponin, Left atrial volume, Left ventricular (LV) systolic and diastolic volume, LV mass, LV ejection fraction, Pulmonary artery systolic pressure, Serum sodium, Serum potassium, Creatinine and glomerular filtration rate, Urinary sodium and potassium and albuminuria, Total Cholesterol, LDL Cholesterol, HDL Cholesterol, Triglycerides, Glucose and HbA1C, Uric acid, TSH and free | — |
Countries
Portugal
Outcome results
None listed