Heart Failure Clinical Trial
— TurkuPETOfficial title:
Controlled Trial on the Short-term Effects of Sacubitril/Valsartan Therapy on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Patients With NYHA II-III Heart Failure and Reduced Systolic Function Using 11C-acetate Positron Emission Tomography and Echocardiography
Verified date | March 2023 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group study. The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on the efficiency of cardiac work in patients with NYHA II-III heart failure (HF) and reduced systolic function using 11C-acetate positron emission tomography (PET) and echocardiography.
Status | Completed |
Enrollment | 55 |
Est. completion date | March 23, 2022 |
Est. primary completion date | March 23, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Novartis Investigative Site | Turku |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myocardial Energetic Efficiency | Positron emission tomography (PET) imaging and echocardiography were performed before randomization (after a minimum of 4 weeks on stable dose of 80 mg BID or 160 mg BID of valsartan) and repeated after 6 weeks on a stable dose of either 80 mg BID or 160 mg BID of valsartan or 100 mg BID or 200 mg BID of sacubitril/valsartan. Cardiac efficiency was calculated based on the following formula: Myocardial efficiency = ((SBP x SV x HR)/LV mass)/Kmono Where SBP : Systolic blood pressure during PET SV : Stroke volume (Echocardiography) HR : Heart rate Kmono: Mono-exponential clearance rate (11C-acetate PET- scan) LV mass: Left ventricular mass Visit 3 was performed after the study treatment was on a stable dose for a minimum of 6 weeks. It could be performed before or after 8 weeks, based on when the last dose modification was performed. No imputation of missing data was performed. |
Baseline, Visit 3 (approximately Week 8) | |
Primary | Change From Baseline in Myocardial Energetic Efficiency | Positron emission tomography (PET) imaging and echocardiography were performed before randomization (after a minimum of 4 weeks on stable dose of 80 mg BID or 160 mg BID of valsartan) and repeated after 6 weeks on a stable dose of either 80 mg BID or 160 mg BID of valsartan or 100 mg BID or 200 mg BID of sacubitril/valsartan. Cardiac efficiency was calculated based on the following formula: Myocardial efficiency = ((SBP x SV x HR)/LV mass)/Kmono Where SBP : Systolic blood pressure during PET SV : Stroke volume (Echocardiography) HR : Heart rate Kmono: Mono-exponential clearance rate (11C-acetate PET- scan) LV mass: Left ventricular mass Visit 3 was performed after the study treatment was on a stable dose for a minimum of 6 weeks. It could be performed before or after 8 weeks, based on when the last dose modification was performed. No imputation of missing data was performed. |
Baseline, Visit 3 (approximately Week 8) | |
Primary | Viable Myocardial Energetic Efficiency (Sensitivity Analysis) | In addition to the derivation of the primary endpoint, an alternative formula was used, where the viable myocardial energetic efficiency was derived as: Viable myocardial energetic efficiency = ((SBP x SV x HR)/LV mass) / vKmono Where vKmono is the viable myocardium clearance rate. This alternative parameter was included as a sensitivity analysis to exclude possible bias related to scar tissue in patients with ischemic myopathy. |
Baseline, Visit 3 (approximately Week 8) | |
Primary | Change From Baseline in Viable Myocardial Energetic Efficiency (Sensitivity Analysis) | In addition to the derivation of the primary endpoint, an alternative formula was used, where the viable myocardial energetic efficiency was derived as: Viable myocardial energetic efficiency = ((SBP x SV x HR)/LV mass) / vKmono Where vKmono is the viable myocardium clearance rate. This alternative parameter was included as a sensitivity analysis to exclude possible bias related to scar tissue in patients with ischemic myopathy. |
Baseline, Visit 3 (approximately Week 8) |
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