Heart failure
Conditions
Interventions
Torsemide (oral dosing of torsemide compared to furosemide will be 1mg: 2.5-5mg) with sacubitril/valsartan 50 mg b.i.d. as started dose, after every 2-4 weeks dose will be up titrated to the goal of 2
Sponsors
Keio University School of Medicine, Department of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with chronic heart failure with/without hospitalization within 1 year before enrollment A. Patients hospitalized with worsening of chronic heart failure, or new diagnosis of heart failure within 1 year before enrollment AND has an elevated natriuretic peptide level (either NT-proBNP greater than or equal to 300 pg/mL or BNP greater than or equal to 100 pg/mL) with the most recent value used to determine eligibility. (In patients with atrial fibrillation, the level of NT-proBNP will be greater than or equal to 450 pg/mL or BNP greater than or equal to 150 pg/mL) B. Patients with chronic heart failure without hospitalization within 1 year before enrollment AND have an elevated natriuretic peptide level (either NT-proBNP greater than or equal to 600 pg/mL or BNP greater than or equal to 150 pg/mL) with the most recent value used to determine eligibility. (In patients with atrial fibrillation, the level of NT-proBNP will be greater than or equal to 900 pg/mL or BNP greater than or equal to 225 pg/mL) 2) Patients with heart failure (NYHA functional class II, III, or IV) receiving oral loop diuretic. 3) Patients whose left ventricular ejection fraction is less than or equal to 50% within 1 year before enrollment. 4) Above 20 years of age 5) Able to consent for the trial.
Exclusion criteria
Exclusion criteria: 1) Symptomatic hypotension and/or a systolic blood pressure < 100 mmHg at screening 2) Serum potassium greater than or equal to5.4 mEq/L at screening 3) eGFR < 30 ml/min/1.73m or end-stage renal disease requiring renal replacement therapy at the time of screening 4) Pregnant or nursing women, or history of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, as well as known or suspected contraindications to the study drugs. 5) Inability or unwillingness to comply with the study requirements 6) Patients who are unable to obtain written consent or require a substitute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean changes in Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) score from the start of the intervention to 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The hierarchical composite endpoint consisting of the time to all-cause death, total number of worsening HFEs, the time to first HFEs within 6 months, and non-improvement in KCCQ-OSS of less than 5 points from baseline to 6 months, assessed by the win ratio. - The composite of all-cause death and the non-improvement in KCCQ-OS score (less than 5 points) from the start of the intervention to 6 months. The mean changes in the NT-proBNP levels from baseline to 6 months. - The composite of all-cause death and non-improvement in the NT-proBNP levels (less than 20%) from the start of the intervention to 6 months. - The composite of all-cause death, heart failure hospitalization, non-improvement in KCCQ-OS score (less than 5 points), and non-improvement in the NT-proBNP levels (less than 20%) from the start of the intervention to 6 months. - The incidence of all-cause death, cardiovascular death, heart failure hospitalization, unscheduled office visits for worsening heart failure with an increasing dose of diuretics or intravenous infusion from the start of the intervention to 6 months. - The mean changes in the KCCQ-clinical summary (KCCQ-CS) score and non-improvement in the KCCQ-CS score (less than 5 points) from the start of the intervention to 6 months. - The mean changes in the KCCQ- total symptom score (KCCQ-TS) and non-improvement in the KCCQ-TS score (less than 5 points) from the start of the intervention to 6 months. - The mean changes in left ventricular ejection fraction (LVEF) from the start of the intervention to 6 months. - The mean changes in estimated glomerular filtration ratio (eGFR) from the start of the intervention to 6 months. - The incidence of all-cause death, cardiovascular death, and heart failure hospitalization from the start of the intervention to 2 years. | — |
Countries
Japan
Contacts
Public ContactYasuyuki Shiraishi
Keio University School of Medicine Department of Cardiology
Outcome results
None listed