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

Overview

To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 20, 2018

Interventions

  • Drug: LCZ696
    • LCZ696 film-coated tables were supplied to the investigators. Tablets were taken with a glass of water, and were administered with or without food. The target dose of LCZ696 was 200 mg twice daily. Starting dose of LCZ696 was either 50 or 100 mg, twice daily. The dose of LCZ696 should be doubled every 2-4 weeks to achieve the target dose of 200 mg twice daily, as tolerated by the patient.

Arms, Groups and Cohorts

  • Other: Pre-discharge treatment initiation
    • Patients received first dose at any point after Randomization but no later than 12 h before discharge.
  • Other: Post-discharge treatment initiation
    • Patients received first dose after discharge and up to 14 days thereafter.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization
    • Time Frame: 10 weeks after Randomization
    • Percentage of patients achieving and maintaining LCZ696 200 mg bid for at least 2 weeks leading to Week 10

Secondary Measures

  • Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid
    • Time Frame: 10 weeks after Randomization
    • Percentage of patients achieving and maintaining either LCZ696 100 mg and/or 200 mg bid for at least 2 weeks leading to Week 10
  • Percentage of Patients Achieving and Maintaining Any Dose of LCZ696
    • Time Frame: 10 weeks after Randomization
    • Percentage of patients achieving any dose of LCZ696 for at least 2 weeks leading to 10 weeks of treatment
  • Percentage of Patients Permanently Discontinued From Treatment
    • Time Frame: 10 weeks after Randomization AND 26 weeks after randomization
    • Percentage of patients permanently discontinued from LCZ696 (1) up to week 10 due to AEs, and (2) up to week 26 due to any reasons

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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