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 )

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.

Condition or disease Intervention/treatment Phase
Heart Failure With Reduced Ejection Fraction Drug: LCZ696 Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1002 participants
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)
Actual Study Start Date : February 12, 2016
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Pre-discharge treatment initiation
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
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.


Post-discharge treatment initiation
Patients received first dose after discharge and up to 14 days thereafter.
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.





Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
Show Show 153 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] July 18, 2016
Statistical Analysis Plan  [PDF] October 18, 2018

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02661217    
Other Study ID Numbers: CLCZ696B2401
2015-003266-87 ( EudraCT Number )
First Posted: January 22, 2016    Key Record Dates
Results First Posted: April 26, 2021
Last Update Posted: April 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
LCZ 696
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action