The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients (TurkuPET)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure with reduced left ventricular ejection fraction, LVEF, Cardiac dysfunction, Heart muscle dysfunction, Left ventricular (LV) dilation, Left ventricular hypertrophy, HF, AHF, CHF, CCF, acute heart failure, chronic heart failure, congestive heart failure, congestive cardiac failure
Eligibility Criteria
Inclusion criteria:
- 40-80 years of age
- Chronic HF with reduced EF (left ventricle EF 25-35%) and NYHA class II-III symptoms.
- Systolic BP 110-160 mm Hg
- Optimal standard HF therapy according to European Society of Cardiology (ESC) guidelines at a stable dose for at least 4 weeks before the screening visit.
Exclusion criteria:
- Estimated glomerular filtration rate (eGFR) < 45 ml/min
- Serum potassium > 5.2 mmol/l and creatinine >1.5 x ULN
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
sacubitril/valsartan
valsartan
Participants will be randomized to two treatment arms in a 1:1, double blinded fashion. Two strengths of sacubitril/valsartan will be available for use after randomization, 49 mg sacubitril/51 mg valsartan and 97 mg sacubitril/103 mg valsartan. After randomization, subjects in this arm will receive sacubitril/valsartan 100 mg orally twice daily (BID). The dose will be then up-titrated to 200 mg BID (or maintained at the starting dose level, if up-titration is not possible). Dose modifications are allowed until week 4 after the randomization. In order to be eligible for the final assessments, the subject has to tolerate the 100 mg BID dose at the minimum. In total, participants will be on sacubitril/valsartan for a minimum of 8 weeks and a maximum of 10 weeks.
Participants will be randomized to two treatment arms in a 1:1, double blinded fashion. In this arm, Valsartan 80 mg and 160 mg will be used as comparative drug, taken orally BID at home. Depending on the screening/run-in dose the subjects in this arm will get either valsartan 80 mg BID or valsartan 160 mg BID. During the treatment period the dose of valsartan will be up-titrated to the highest tolerated dose (160 mg BID) or maintained at 80 mg BID if up-titration is not possible. Dose modifications are allowed until week 4 after the randomization. In order to be eligible for the final assessments, the subject has to tolerate at least 80 mg BID dose of valsartan. The treatment phase will be a minimum of 8 weeks, and a maximum of 10 weeks.