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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.
Verified November 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02661217
First Posted: January 22, 2016
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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: Single (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: June 6, 2018
Estimated Primary Completion Date: February 8, 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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661217


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

  Show 180 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 )
First Submitted: January 19, 2016
First Posted: January 22, 2016
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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