Phase 4
N=1,002
Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event
Heart Failure With Reduced Ejection Fraction
Bottom Line
View on ClinicalTrials.gov: NCT02661217 ↗Enrolled (actual)
1,002
Serious AEs
29.8%
Results posted
Apr 2021
Primary outcome: Primary: Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization — 224; 248 Participants — p=0.099
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- LCZ696 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization |
224; 248 | 0.099 |
| SECONDARY Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid |
306; 335 | 0.034 sig |
| SECONDARY Percentage of Patients Achieving and Maintaining Any Dose of LCZ696 |
424; 438 | 0.089 |
| SECONDARY Percentage of Patients Permanently Discontinued From Treatment |
36; 24; 83; 78 | — |
Summary
To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.
Eligibility Criteria
Inclusion Criteria
- Patients hospitalized due to acute decompensated HF episode (ADHF) as primary diagnosis) and consistent Signs & Symptoms
- Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection fraction: Left ventricular ejection fraction ≤ 40% at Screening
- Patients did not receive any IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for ADHF to Randomization
- Stabilized (while in the hospital) for at least 24 hours leading to Randomization.
- Meeting one of the following criteria:
- Patients on any dose of ACEI or ARB at screening
- ACEI/ARB naïve patients and patients not on ACEI or ARB for at least 4 weeks before screening.
Exclusion Criteria
- History of hypersensitivity to the sacubitril, valsartan, or any ARBs, NEP inhibitors or to any of the LCZ696 excipients.
- Symptomatic hypotension and/or a SBP below 110 mm Hg or SBP above 180 mm Hg prior to randomization
- End stage renal disease at Screening; or estimated GFR below 30 mL/min/1.73 m2 (as measured by MDRD formula at Randomization.
- Serum potassium above 5.4 mmol/L at Randomization.
- Known history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy
- Severe hepatic impairment, biliary cirrhosis and cholestasis
Data sourced from ClinicalTrials.gov (NCT02661217). 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.