Phase 3 N=4,822 Randomized Double-blind Treatment

Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction

Heart Failure With Preserved Ejection Fraction

Bottom Line

View on ClinicalTrials.gov: NCT01920711 ↗

Enrolled (actual)

4,822

Serious AEs

58.9%

Results posted

Sep 2020

Primary outcome: Primary: Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. — 894; 1009; 690; 797 Events — p=0.0587

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: LCZ696 (Drug); Valsartan (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations.	894; 1009; 690; 797; 204; 212	0.0587
SECONDARY Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ)	-1.5073; -2.5338	0.0510
SECONDARY Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class	347; 289; 1767; 1792; 202; 221	0.0035 sig
SECONDARY Participants With First Occurrence of a Composite Renal Endpoint	33; 64; 1; 1; 7; 12	0.0014 sig
SECONDARY All-cause Mortality	342; 349	0.6846

Summary

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.

Eligibility Criteria

Inclusion Criteria

Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or within 6 months prior to study entry.
Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry.
Current symptom(s) of HF (NYHA class II-IV)
Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
Elevated NT-proBNP

Exclusion Criteria

Any prior measurement of LVEF 40 kg/m2.
Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at entry.

Other protocol-defined inclusion/exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01920711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.