50 and older, any sex, with Heart Failure With Preserved Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations.Primary· Total follow up time (up to 57 months)
The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of CV death and total (first and recurrent) HF hospitalizations, in HF patients (New York Heart Association \[NYHA\] Class II-IV) with preserved ejection fraction (left ventricular ejection fraction \[LVEF\] ≥45%). The treatment arm with the lower rate of events will be deemed as having a successful response.
Primary Composite Events
Group
Value
95% CI
LCZ696
894
Valsartan
1009
Total Hospitalizations for heart failure
Group
Value
95% CI
LCZ696
690
Valsartan
797
Cardiovascular death
Group
Value
95% CI
LCZ696
204
Valsartan
212
Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ)Secondary· Baseline, 8 months
The KCCQ is a validated instrument for self-assessment of quality of life and health status in heart failure (HF) patients. The clinical summary score, which is derived from the physical limitations and heart failure (HF) symptoms domains of the KCCQ is a valid measure for assessing the patient's health aspects that may be influenced by CV medications. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Evaluation of change from baseline to month 8 in KCCQ a most sensitive, specific, and responsive health-related quality of life measure for heart fa
Group
Value
95% CI
LCZ696
-1.5073
± 0.3709
Valsartan
-2.5338
± 0.3729
Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional ClassSecondary· Baseline, 8 months
Evaluation of change from baseline to Month 8 in NYHA functional class, a well established grading scale used to classify a heart failure's (HF) patients' level of functionality based on the signs and symptoms of HF exhibited by the patient.
Improved (n=2316, 2302)
Group
Value
95% CI
LCZ696
347
Valsartan
289
Unchanged (n=2316, 2302)
Group
Value
95% CI
LCZ696
1767
Valsartan
1792
Worsened (n=2316, 2302)
Group
Value
95% CI
LCZ696
202
Valsartan
221
Participants With First Occurrence of a Composite Renal EndpointSecondary· Randomization to total follow-up time (up to 57 months)
Analyis of composite renal endpoint defined as renal death, or reaching ESRD, or ≥50% decline in eGFR relative to baseline, using Cox's proportional hazards model.
Composite renal endpoint
Group
Value
95% CI
LCZ696
33
Valsartan
64
Renal Death
Group
Value
95% CI
LCZ696
1
Valsartan
1
Reaching ESRD
Group
Value
95% CI
LCZ696
7
Valsartan
12
>=50% decline in eGFR from baseline
Group
Value
95% CI
LCZ696
27
Valsartan
60
All-cause MortalitySecondary· Randomization to total follow up time (up to 57 months)
Analysis for all-cause mortality using Cox's proportional hazards model.
Group
Value
95% CI
LCZ696
342
Valsartan
349
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 5 years..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04164732 — Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy
· Phase 2
· completed
NCT03872778 — [177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake
· Phase 1, PHASE2
· completed
NCT03909295 — An Open-label Extension Study Evaluating Safety and Tolerability of LCZ696 in Subjects Who Completed PARAGON-HF in Japan
· Phase 3
· terminated
NCT03917459 — COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
· Phase 3
· completed
Other recruiting trials for Heart Failure With Preserved Ejection Fraction
Currently open trials in the same condition.
NCT06833138 — Atrioventricular Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillati
· NA
· recruiting
NCT06937827 — Transitions of Care Clinic (TOCC)
· NA
· recruiting
NCT07037459 — Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
· Phase 3
· recruiting
NCT06702501 — The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF)
· NA
· recruiting
NCT06616974 — A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction
· Phase 2
· recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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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: 29 September 2020
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/NCT01920711.