Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02661217
• Date of registration: 19/01/2016
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event TRANSITION
• Scientific title: A Multicenter, Randomized, Open Label, Parallel Group Study Comparing Pre-discharge and posT-discharge tReatment Initiation With LCZ696 in heArt Failure patieNtS With Reduced ejectIon-fracTion hospItalized for an Acute decOmpensation eveNt (ADHF)
• Date of first enrolment: February 12, 2016
• Target sample size: 1000
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02661217
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Argentina, Belgium, Canada, Czech Republic, Czechia, France, Germany, Italy, Lebanon, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients hospitalized due to acute decompensated HF episode (ADHF) as primary
diagnosis) and consistent Signs & Symptoms

2. Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection
fraction: Left ventricular ejection fraction = 40% at Screening

3. Patients did not receive any IV vasodilators (except nitrates), and/or any IV
inotropic therapy from the time of presentation for ADHF to Randomization

4. Stabilized (while in the hospital) for at least 24 hours leading to Randomization.

5. 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:

1. History of hypersensitivity to the sacubitril, valsartan, or any ARBs, NEP inhibitors
or to any of the LCZ696 excipients.

2. Symptomatic hypotension and/or a SBP below 110 mm Hg or SBP above 180 mm Hg prior to
randomization

3. End stage renal disease at Screening; or estimated GFR below 30 mL/min/1.73 m2 (as
measured by MDRD formula at Randomization.

4. Serum potassium above 5.4 mmol/L at Randomization.

5. Known history of hereditary or idiopathic angioedema or angioedema related to previous
ACE inhibitor or ARB therapy

6. Severe hepatic impairment, biliary cirrhosis and cholestasis



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure With Reduced Ejection Fraction

Intervention(s)

Drug: LCZ696

Primary Outcome(s)

Percentage of patients who are receiving 200 mg LCZ696 bid [Time Frame: 10 weeks after Randomization]

Secondary Outcome(s)

Number of patients who, regardless of previous dose changes, achieved any dose of LCZ696 bid for at least 2 weeks [Time Frame: 10 weeks after Randomization]

Percentage of patients permanently discontinued from treatment due to Adverse Events [Time Frame: 10 weeks after Randomization AND 26 weeks]

Number of patients who achieved and maintained either the dose of 100 mg and/or 200 mg LCZ696 bid for at least 2 weeks [Time Frame: 10 weeks after Randomization]

Secondary ID(s)

CLCZ696B2401

2015-003266-87

Source(s) of Monetary Support

Please refer to primary and secondary sponsors