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
Baseline (Day 1)
Group
Value
95% CI
Sacubitril/Valsartan
48621.3
± 17001.4
Valsartan
50035.7
± 18068.2
Visit 3
Group
Value
95% CI
Sacubitril/Valsartan
50301.0
± 20842.7
Valsartan
52942.8
± 19702.5
Change From Baseline in Myocardial Energetic EfficiencyPrimary· Baseline, Visit 3 (approximately Week 8)
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
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
Group
Value
95% CI
Sacubitril/Valsartan
48163.0
± 16719.8
Valsartan
49575.6
± 18255.8
Visit 3
Group
Value
95% CI
Sacubitril/Valsartan
49914.4
± 20821.2
Valsartan
52249.9
± 19585.8
Change From Baseline in Viable Myocardial Energetic Efficiency (Sensitivity Analysis)Primary· Baseline, Visit 3 (approximately Week 8)
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.
Group
Value
95% CI
Sacubitril/Valsartan
1751.4
± 9098.1
Valsartan
2674.3
± 11551.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 86 days..
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 5 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03300427.