Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02661217
Recruitment Status : Completed
First Posted : January 22, 2016
Results First Posted : April 26, 2021
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE January 19, 2016
First Posted Date  ICMJE January 22, 2016
Results First Submitted Date  ICMJE June 20, 2019
Results First Posted Date  ICMJE April 26, 2021
Last Update Posted Date April 26, 2021
Actual Study Start Date  ICMJE February 12, 2016
Actual Primary Completion Date February 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event
Official Title  ICMJE 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)
Brief Summary To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Heart Failure With Reduced Ejection Fraction
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Pre-discharge treatment initiation
    Patients received first dose at any point after Randomization but no later than 12 h before discharge.
    Intervention: Drug: LCZ696
  • Post-discharge treatment initiation
    Patients received first dose after discharge and up to 14 days thereafter.
    Intervention: Drug: LCZ696
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2021)
1002
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2016)
1000
Actual Study Completion Date  ICMJE June 20, 2018
Actual Primary Completion Date February 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Canada,   Czechia,   France,   Germany,   Italy,   Lebanon,   Norway,   Poland,   Portugal,   Russian Federation,   Saudi Arabia,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02661217
Other Study ID Numbers  ICMJE CLCZ696B2401
2015-003266-87 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP