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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02661217
First received: January 19, 2016
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.

Condition Intervention Phase
Heart Failure With Reduced Ejection Fraction Drug: LCZ696 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Supportive Care
Official 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)

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Percentage of patients who are receiving 200 mg LCZ696 bid [ Time Frame: 10 weeks after Randomization ]
    Assessing the percentage of patients who achieve the target dose of 200 mg bid LCZ696 at 10 weeks after randomization


Secondary Outcome Measures:
  • 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 ]
    Assessing number of patients achieving and maintaining either dose of 100 mg and/or 200 mg LCZ696 bid for at least 2 weeks

  • 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 ]
    Assessing number of patients achieving and maintaining any dose of LCZ696 bid for at least 2 weeks

  • Percentage of patients permanently discontinued from treatment due to Adverse Events [ Time Frame: 10 weeks after Randomization AND 26 weeks ]
    Percentage of patients permanently discontinued from LCZ696 (1) up to week-10, and (2) up to week 26, due to AEs


Estimated Enrollment: 1000
Actual Study Start Date: February 12, 2016
Estimated Study Completion Date: July 17, 2018
Estimated Primary Completion Date: March 21, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pre-discharge treatment initiation
Patients randomized to Pre-discharge treatment initiation could receive first dose of LCZ696 at any point after the investigator deemed the patient to be stable for at least 24 h, relatively to the ongoing acute HF-therapy.
Drug: LCZ696
The target dose of LCZ696 is 200 mg twice daily. Starting dose of LCZ696 is 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.
Post-discharge treatment initiation
Patients randomized to Post-discharge treatment initiation could receive the first LCZ696 dose at any point between the day after discharge and up to 14 days after Discharge.
Drug: LCZ696
The target dose of LCZ696 is 200 mg twice daily. Starting dose of LCZ696 is 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02661217

Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

  Show 163 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02661217     History of Changes
Other Study ID Numbers: CLCZ696B2401
2015-003266-87 ( EudraCT Number )
Study First Received: January 19, 2016
Last Updated: May 12, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Acute decompensated heart failure
Reduced ejection fraction
Pre-discharge treatment
Post-discharge treatment
Angiotensin receptor neprilysine inhibitor
HFrEF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
LCZ 696
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017