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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Heart Failure With Reduced Ejection Fraction
Intervention Drug: LCZ696
Enrollment 1002
Recruitment Details Patients were randomized to pre-discharge group or post-discharged group.
Pre-assignment Details The study consisted of 3 Epochs: the Screening Epoch (from signing of informed consent form to randomization), the treatment epoch (10 weeks following randomization), and a 16 weeks Follow-up Epoch following treatment epoch.
Arm/Group Title LCZ696 Pre-discharge Treatment Initiation LCZ696 Post-discharge Treatment Initiation
Hide Arm/Group Description Patients received first dose at any point after Randomization but no later than 12 h before discharge. Patients received first dose after discharge and up to 14 days thereafter.
Period Title: Overall Study
Started [1] 500 502
Started 10 Weeks Treatment Epoch 497 501
Completed 10 Weeks Treatment Epoch 460 455
Completed [2] 425 419
Not Completed 75 83
Reason Not Completed
Physician Decision             12             15
Lost to Follow-up             1             4
Protocol Deviation             0             4
Non-compliance with study treatment             5             5
Death             21             15
Adverse Event             10             8
Withdrawal by Subject             15             19
Did not enter follow-up epoch             7             10
Death - no study drug received             1             2
Mis-randomized (not in treatment epoch)             3             1
[1]
Randomized
[2]
Completed 16 weeks follow-up epoch
Arm/Group Title LCZ696 Pre-discharge Treatment Initiation LCZ696 Post-discharge Treatment Initiation Total
Hide Arm/Group Description Patients received first dose at any point after Randomization but no later than 12 h before discharge. Patients received first dose after discharge and up to 14 days thereafter. Total of all reporting groups
Overall Number of Baseline Participants 500 502 1002
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 500 participants 502 participants 1002 participants
66.7  (12.27) 67.0  (11.67) 66.8  (11.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 502 participants 1002 participants
Female
126
  25.2%
125
  24.9%
251
  25.0%
Male
374
  74.8%
377
  75.1%
751
  75.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 502 participants 1002 participants
Caucasian
488
  97.6%
486
  96.8%
974
  97.2%
Black
5
   1.0%
8
   1.6%
13
   1.3%
Asian
7
   1.4%
3
   0.6%
10
   1.0%
Native American
0
   0.0%
1
   0.2%
1
   0.1%
Pacific Islander
0
   0.0%
1
   0.2%
1
   0.1%
Other
0
   0.0%
1
   0.2%
1
   0.1%
Unknown
0
   0.0%
2
   0.4%
2
   0.2%
1.Primary Outcome
Title Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization
Hide Description Percentage of patients achieving and maintaining LCZ696 200 mg bid for at least 2 weeks leading to Week 10
Time Frame 10 weeks after Randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received.
Arm/Group Title LCZ696 Pre-discharge Treatment Initiation LCZ696 Post-discharge Treatment Initiation
Hide Arm/Group Description:
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
Patients received first dose after discharge and up to 14 days thereafter.
Overall Number of Participants Analyzed 493 489
Measure Type: Count of Participants
Unit of Measure: Participants
224
  45.4%
248
  50.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCZ696 Pre-discharge Treatment Initiation, LCZ696 Post-discharge Treatment Initiation
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.896
Confidence Interval (2-Sided) 95%
0.786 to 1.021
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid
Hide Description Percentage of patients achieving and maintaining either LCZ696 100 mg and/or 200 mg bid for at least 2 weeks leading to Week 10
Time Frame 10 weeks after Randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received.
Arm/Group Title LCZ696 Pre-discharge Treatment Initiation LCZ696 Post-discharge Treatment Initiation
Hide Arm/Group Description:
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
Patients received first dose after discharge and up to 14 days thereafter.
Overall Number of Participants Analyzed 493 489
Measure Type: Count of Participants
Unit of Measure: Participants
306
  62.1%
335
  68.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCZ696 Pre-discharge Treatment Initiation, LCZ696 Post-discharge Treatment Initiation
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.906
Confidence Interval (2-Sided) 95%
0.827 to 0.993
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients Achieving and Maintaining Any Dose of LCZ696
Hide Description Percentage of patients achieving any dose of LCZ696 for at least 2 weeks leading to 10 weeks of treatment
Time Frame 10 weeks after Randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received.
Arm/Group Title LCZ696 Pre-discharge Treatment Initiation LCZ696 Post-discharge Treatment Initiation
Hide Arm/Group Description:
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
Patients received first dose after discharge and up to 14 days thereafter.
Overall Number of Participants Analyzed 493 489
Measure Type: Count of Participants
Unit of Measure: Participants
424
  86.0%
438
  89.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LCZ696 Pre-discharge Treatment Initiation, LCZ696 Post-discharge Treatment Initiation
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.960
Confidence Interval (2-Sided) 95%
0.916 to 1.006
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Patients Permanently Discontinued From Treatment
Hide Description 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
Time Frame 10 weeks after Randomization AND 26 weeks after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received.
Arm/Group Title LCZ696 Pre-discharge Treatment Initiation LCZ696 Post-discharge Treatment Initiation
Hide Arm/Group Description:
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
Patients received first dose after discharge and up to 14 days thereafter.
Overall Number of Participants Analyzed 493 489
Measure Type: Count of Participants
Unit of Measure: Participants
up to week 10 due to AEs
36
   7.3%
24
   4.9%
up to week 26 due to any reasons
83
  16.8%
78
  16.0%
5.Post-Hoc Outcome
Title All Collected Deaths
Hide Description

Pre-treatment deaths were collected from randomization until first treatment with LCZ696. The period from randomization to first treatment was up to 14 days.

On-treatment deaths were collected from first treatment with LCZ696 until 26 weeks post randomization.

Time Frame From randomization until 26 weeks after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (SAF) and randomized patients who died prior to first dose of study drug. The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received.
Arm/Group Title LCZ696 Pre-discharge Treatment Initiation LCZ696 Post-discharge Treatment Initiation
Hide Arm/Group Description:
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
Patients received first dose after discharge and up to 14 days thereafter.
Overall Number of Participants Analyzed 494 491
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-treatment deaths
1
   0.2%
2
   0.4%
On-treatment deaths
23
   4.7%
13
   2.6%
All deaths
24
   4.9%
15
   3.1%
Time Frame From start of treatment until 26 weeks after randomization
Adverse Event Reporting Description

Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug.

Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and .

Patients are analyzed according to treatment actually received.

 
Arm/Group Title Pre-discharge Post-discharge All Patients
Hide Arm/Group Description Pre-discharge Post-discharge All patients
All-Cause Mortality
Pre-discharge Post-discharge All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/493 (4.67%)   13/489 (2.66%)   36/982 (3.67%) 
Hide Serious Adverse Events
Pre-discharge Post-discharge All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   159/493 (32.25%)   134/489 (27.40%)   293/982 (29.84%) 
Blood and lymphatic system disorders       
Anaemia  1  3/493 (0.61%)  2/489 (0.41%)  5/982 (0.51%) 
Hypocoagulable state  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Leukocytosis  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Splenic haemorrhage  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Cardiac disorders       
Acute coronary syndrome  1  1/493 (0.20%)  2/489 (0.41%)  3/982 (0.31%) 
Acute myocardial infarction  1  1/493 (0.20%)  3/489 (0.61%)  4/982 (0.41%) 
Angina pectoris  1  2/493 (0.41%)  1/489 (0.20%)  3/982 (0.31%) 
Angina unstable  1  3/493 (0.61%)  0/489 (0.00%)  3/982 (0.31%) 
Arrhythmia  1  2/493 (0.41%)  1/489 (0.20%)  3/982 (0.31%) 
Arteriosclerosis coronary artery  1  2/493 (0.41%)  0/489 (0.00%)  2/982 (0.20%) 
Atrial fibrillation  1  4/493 (0.81%)  5/489 (1.02%)  9/982 (0.92%) 
Atrial flutter  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Atrial tachycardia  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Atrioventricular block complete  1  2/493 (0.41%)  2/489 (0.41%)  4/982 (0.41%) 
Bradycardia  1  2/493 (0.41%)  1/489 (0.20%)  3/982 (0.31%) 
Cardiac arrest  1  4/493 (0.81%)  1/489 (0.20%)  5/982 (0.51%) 
Cardiac failure  1  46/493 (9.33%)  45/489 (9.20%)  91/982 (9.27%) 
Cardiac failure acute  1  11/493 (2.23%)  9/489 (1.84%)  20/982 (2.04%) 
Cardiac failure chronic  1  3/493 (0.61%)  2/489 (0.41%)  5/982 (0.51%) 
Cardiac failure congestive  1  1/493 (0.20%)  4/489 (0.82%)  5/982 (0.51%) 
Cardio-respiratory arrest  1  1/493 (0.20%)  2/489 (0.41%)  3/982 (0.31%) 
Cardiogenic shock  1  1/493 (0.20%)  5/489 (1.02%)  6/982 (0.61%) 
Cardiomyopathy  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Congestive cardiomyopathy  1  0/493 (0.00%)  2/489 (0.41%)  2/982 (0.20%) 
Coronary artery disease  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Ischaemic cardiomyopathy  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Left ventricular failure  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Low cardiac output syndrome  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Mitral valve incompetence  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Myocardial fibrosis  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Myocardial infarction  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Myocardial ischaemia  1  2/493 (0.41%)  0/489 (0.00%)  2/982 (0.20%) 
Palpitations  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Sinus arrest  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Sinus node dysfunction  1  1/493 (0.20%)  2/489 (0.41%)  3/982 (0.31%) 
Supraventricular tachycardia  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Ventricular arrhythmia  1  1/493 (0.20%)  2/489 (0.41%)  3/982 (0.31%) 
Ventricular extrasystoles  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Ventricular fibrillation  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Ventricular tachycardia  1  3/493 (0.61%)  2/489 (0.41%)  5/982 (0.51%) 
Congenital, familial and genetic disorders       
Tracheo-oesophageal fistula  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Endocrine disorders       
Hypothyroidism  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Gastrointestinal disorders       
Abdominal pain upper  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Diarrhoea  1  0/493 (0.00%)  3/489 (0.61%)  3/982 (0.31%) 
Diarrhoea haemorrhagic  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Gastritis  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Gastrointestinal haemorrhage  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Gastrointestinal inflammation  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Intestinal haemorrhage  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Lip swelling  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Melaena  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Rectal haemorrhage  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Subileus  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
General disorders       
Asthenia  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Impaired healing  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Multiple organ dysfunction syndrome  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Non-cardiac chest pain  1  2/493 (0.41%)  5/489 (1.02%)  7/982 (0.71%) 
Oedema peripheral  1  1/493 (0.20%)  3/489 (0.61%)  4/982 (0.41%) 
Pyrexia  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Sudden cardiac death  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Sudden death  1  2/493 (0.41%)  0/489 (0.00%)  2/982 (0.20%) 
Hepatobiliary disorders       
Acute hepatic failure  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Cholecystitis acute  1  2/493 (0.41%)  0/489 (0.00%)  2/982 (0.20%) 
Hepatic function abnormal  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Hepatitis  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Hyperbilirubinaemia  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Jaundice cholestatic  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Infections and infestations       
Bacterial sepsis  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Biliary sepsis  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Bronchitis  1  1/493 (0.20%)  4/489 (0.82%)  5/982 (0.51%) 
Catheter site abscess  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Cellulitis  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Device related infection  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Diarrhoea infectious  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Endocarditis  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Epididymitis  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Erysipelas  1  1/493 (0.20%)  3/489 (0.61%)  4/982 (0.41%) 
Gangrene  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Gastroenteritis  1  1/493 (0.20%)  3/489 (0.61%)  4/982 (0.41%) 
Influenza  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Localised infection  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Lower respiratory tract infection  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Lower respiratory tract infection viral  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Lung infection  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Pneumonia  1  7/493 (1.42%)  8/489 (1.64%)  15/982 (1.53%) 
Postoperative wound infection  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Q fever  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Respiratory tract infection  1  0/493 (0.00%)  4/489 (0.82%)  4/982 (0.41%) 
Sepsis  1  2/493 (0.41%)  1/489 (0.20%)  3/982 (0.31%) 
Septic phlebitis  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Septic shock  1  1/493 (0.20%)  2/489 (0.41%)  3/982 (0.31%) 
Tuberculosis  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Urinary tract infection  1  4/493 (0.81%)  2/489 (0.41%)  6/982 (0.61%) 
Urosepsis  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Injury, poisoning and procedural complications       
Concussion  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Craniocerebral injury  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Femoral neck fracture  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Hip fracture  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Humerus fracture  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Multiple injuries  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Patella fracture  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Post procedural haematoma  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Radius fracture  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Rib fracture  1  1/493 (0.20%)  2/489 (0.41%)  3/982 (0.31%) 
Spinal fracture  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Subdural haematoma  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Transplant failure  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Investigations       
Blood creatinine increased  1  2/493 (0.41%)  0/489 (0.00%)  2/982 (0.20%) 
Cardiac output decreased  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Ejection fraction abnormal  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Ejection fraction decreased  1  0/493 (0.00%)  2/489 (0.41%)  2/982 (0.20%) 
General physical condition abnormal  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Heart rate abnormal  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Hepatic enzyme abnormal  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Hepatic enzyme increased  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
International normalised ratio increased  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Weight increased  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Metabolism and nutrition disorders       
Dehydration  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Diabetes mellitus inadequate control  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Fluid overload  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Gout  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Hyperglycaemia  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Hyperkalaemia  1  3/493 (0.61%)  6/489 (1.23%)  9/982 (0.92%) 
Hypoglycaemia  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Hyponatraemia  1  1/493 (0.20%)  2/489 (0.41%)  3/982 (0.31%) 
Musculoskeletal and connective tissue disorders       
Bursitis  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Fistula  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Intervertebral disc protrusion  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Musculoskeletal pain  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Myalgia  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Osteoarthritis  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Pain in extremity  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma gastric  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Brain neoplasm  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Breast cancer  1  2/493 (0.41%)  0/489 (0.00%)  2/982 (0.20%) 
Lung neoplasm malignant  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Malignant neoplasm of ampulla of Vater  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Malignant peritoneal neoplasm  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Metastases to liver  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Metastases to lung  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Rectal adenocarcinoma  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Transitional cell carcinoma  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Nervous system disorders       
Aphasia  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Autonomic nervous system imbalance  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Brain injury  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Cerebral arteriosclerosis  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Cerebral ischaemia  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Cerebrovascular accident  1  1/493 (0.20%)  2/489 (0.41%)  3/982 (0.31%) 
Cognitive disorder  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Dizziness  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Extrapyramidal disorder  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Headache  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Hypoxic-ischaemic encephalopathy  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Ischaemic stroke  1  0/493 (0.00%)  2/489 (0.41%)  2/982 (0.20%) 
Loss of consciousness  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Presyncope  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Sciatica  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Syncope  1  3/493 (0.61%)  3/489 (0.61%)  6/982 (0.61%) 
Transient ischaemic attack  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Product Issues       
Device battery issue  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Device dislocation  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Psychiatric disorders       
Insomnia  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Renal and urinary disorders       
Acute kidney injury  1  12/493 (2.43%)  7/489 (1.43%)  19/982 (1.93%) 
Chronic kidney disease  1  3/493 (0.61%)  2/489 (0.41%)  5/982 (0.51%) 
Haematuria  1  0/493 (0.00%)  2/489 (0.41%)  2/982 (0.20%) 
Renal failure  1  3/493 (0.61%)  4/489 (0.82%)  7/982 (0.71%) 
Renal impairment  1  0/493 (0.00%)  4/489 (0.82%)  4/982 (0.41%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Respiratory, thoracic and mediastinal disorders       
Acute pulmonary oedema  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Acute respiratory failure  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Asthma  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Chronic obstructive pulmonary disease  1  3/493 (0.61%)  4/489 (0.82%)  7/982 (0.71%) 
Cough  1  1/493 (0.20%)  1/489 (0.20%)  2/982 (0.20%) 
Dyspnoea  1  6/493 (1.22%)  5/489 (1.02%)  11/982 (1.12%) 
Haemoptysis  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Mediastinal haematoma  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Orthopnoea  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Pleural effusion  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Pulmonary congestion  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Pulmonary embolism  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Pulmonary oedema  1  3/493 (0.61%)  7/489 (1.43%)  10/982 (1.02%) 
Respiratory failure  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Skin and subcutaneous tissue disorders       
Diabetic foot  1  1/493 (0.20%)  2/489 (0.41%)  3/982 (0.31%) 
Skin ulcer  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Vascular disorders       
Aortic aneurysm  1  0/493 (0.00%)  1/489 (0.20%)  1/982 (0.10%) 
Hypertension  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Hypotension  1  6/493 (1.22%)  2/489 (0.41%)  8/982 (0.81%) 
Peripheral arterial occlusive disease  1  1/493 (0.20%)  0/489 (0.00%)  1/982 (0.10%) 
Peripheral vascular disorder  1  2/493 (0.41%)  0/489 (0.00%)  2/982 (0.20%) 
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pre-discharge Post-discharge All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   200/493 (40.57%)   201/489 (41.10%)   401/982 (40.84%) 
Gastrointestinal disorders       
Diarrhoea  1  17/493 (3.45%)  29/489 (5.93%)  46/982 (4.68%) 
General disorders       
Oedema peripheral  1  20/493 (4.06%)  26/489 (5.32%)  46/982 (4.68%) 
Infections and infestations       
Urinary tract infection  1  29/493 (5.88%)  19/489 (3.89%)  48/982 (4.89%) 
Metabolism and nutrition disorders       
Hyperkalaemia  1  67/493 (13.59%)  59/489 (12.07%)  126/982 (12.83%) 
Nervous system disorders       
Dizziness  1  32/493 (6.49%)  30/489 (6.13%)  62/982 (6.31%) 
Renal and urinary disorders       
Renal impairment  1  36/493 (7.30%)  24/489 (4.91%)  60/982 (6.11%) 
Vascular disorders       
Hypotension  1  71/493 (14.40%)  67/489 (13.70%)  138/982 (14.05%) 
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: novartis.email@novartis.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02661217    
Other Study ID Numbers: CLCZ696B2401
2015-003266-87 ( EudraCT Number )
First Submitted: January 19, 2016
First Posted: January 22, 2016
Results First Submitted: June 20, 2019
Results First Posted: April 26, 2021
Last Update Posted: April 26, 2021