Phase 3
Completed N=4,822
Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
Source: ClinicalTrials.gov NCT01920711 ↗Enrolled (actual)
4,822
Serious AEs
58.9%
Results posted
Sep 2020
Primary outcomePrimary: 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
◆ Published Evidence
Established
97citations · ~97 / year
Near-universal prevalence of central adiposity in heart failure with preserved ejection fraction: the PARAGON-HF trial.
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.
Linked Publications (5)
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Near-universal prevalence of central adiposity in heart failure with preserved ejection fraction: the PARAGON-HF trial.
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Prognostic Significance of Nutritional Scores in Patients With Heart Failure: Insights From the PARAGON-HF Trial.
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Angiotensin Receptor Neprilysin Inhibition and Cardiovascular Outcomes Across the Kidney Function Spectrum: The PARAGON-HF Trial.
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Effects of Sacubitril/Valsartan According to Natriuretic Peptide Levels in Patients Enrolled in PARADIGM-HF and PARAGON-HF.
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Sacubitril/valsartan and quality of life assessed using the EuroQol Five-dimension Three-level questionnaire level sum score (EQ-5D-3L-LSS) in patients with HFrEF and HFmrEF/HFpEF.
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 |
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.
Data sourced from ClinicalTrials.gov (NCT01920711) and the linked publication. 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. Informational only — not medical advice.