randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure (OUTSTEP-HF)
|
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: NCT02900378 |
|
Recruitment Status :
Completed
First Posted : September 14, 2016
Results First Posted : September 16, 2019
Last Update Posted : September 2, 2020
|
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Chronic Heart Failure With Reduced Ejection Fraction |
| Interventions |
Drug: LCZ696 (Sacubitril/Valsartan) Drug: Placebo of LCZ696 (Sacubitril/Valsartan) Drug: Enalapril Drug: Placebo of Enalapril |
| Enrollment | 621 |
Participant Flow
| Recruitment Details | This study was conducted at 120 centers in 19 countries worldwide (Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Netherlands, Norway, Poland, Spain, Sweden and UK). |
| Pre-assignment Details | It was planned to recruit 300 patients per treatment arm, i.e. 600 patients in total. A total of 764 patients were screened, of whom 621 patients were randomized (310 in the sacubitril/valsartan group and 311 in the enalapril group). |
| Arm/Group Title | LCZ696 (Sacubitril/Valsartan) | Enalapril |
|---|---|---|
 Arm/Group Description |
LCZ696 (Sacubitril/Valsartan) or its matching placebo twice a day for 12 weeks. Patients began study treatment (Sacubitril/Valsartan) at a specific dose level according to their pre-study ACEI/ARB dose (1 (24 mg/26 mg LCZ), 2 (49 mg/51 mg LCZ) or 2a (49 mg/51 mg LCZ)) or matching placebo and were up-titrated according to an up-titration scheme. | Enalapril or its matching placebo twice a day for 12 weeks. Patients began study treatment (Enalapril) at a specific dose level according to their pre-study ACEI/ARB dose (1 (2.5 mg), 2a (5 mg)) or matching placebo and were up-titrated according to an up-titration scheme. |
| Period Title: Randomization (Visit 2) | ||
| Started [1] | 310 | 311 |
| Completed | 287 | 283 |
| Not Completed | 23 | 28 |
| Reason Not Completed | ||
| Adverse Event | 14 | 11 |
| Death | 1 | 4 |
| Lost to Follow-up | 1 | 0 |
| Non-compliance with Study Drug | 1 | 1 |
| Protocol Deviation | 1 | 7 |
| Withdrawal by Parent/Guardian | 5 | 3 |
| Withdrawal of Informed Consent | 0 | 2 |
|
[1]
All randomized patients
|
||
| Period Title: Treatment Phase | ||
| Started [1] | 309 | 310 |
| Full Analysis Set [2] | 302 | 302 |
| Completed | 309 | 310 |
| Not Completed | 0 | 0 |
|
[1]
All randomized patients with at least 1 dose of study treatment
[2]
At least 1 dose of study treatment and 1 post baseline safety assessment
|
||
Baseline Characteristics
| Arm/Group Title | LCZ696 (Sacubitril/Valsartan) | Enalapril | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
LCZ696 (Sacubitril/Valsartan) or its matching placebo twice a day for 12 weeks. Patients began study treatment (Sacubitril/Valsartan) at a specific dose level according to their pre-study ACEI/ARB dose (1 (24 mg/26 mg LCZ), 2 (49 mg/51 mg LCZ) or 2a (49 mg/51 mg LCZ)) or matching placebo and were up-titrated according to an up-titration scheme. | Enalapril or its matching placebo twice a day for 12 weeks. Patients began study treatment (Enalapril) at a specific dose level according to their pre-study ACEI/ARB dose (1 (2.5 mg), 2a (5 mg)) or matching placebo and were up-titrated according to an up-titration scheme. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 310 | 311 | 621 | |
|
Baseline Analysis Population Description |
All randomized patients are represented in the overall number of Baseline Participants. The Demographic and Baseline Characteristics were done in the Safety Analysis Set.
|
|||
|
Age, Continuous
[1] Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 309 participants | 310 participants | 619 participants | |
| 67.16 (11.04) | 66.62 (10.45) | 66.89 (10.74) | ||
|
[1]
Measure Analysis Population Description: The Demographic and Baseline Characteristics were done in the Safety Analysis Set.
|
||||
|
Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 309 participants | 310 participants | 619 participants | |
| Female |
71 23.0%
|
61 19.7%
|
132 21.3%
|
|
| Male |
238 77.0%
|
249 80.3%
|
487 78.7%
|
|
|
[1]
Measure Analysis Population Description: The Demographic and Baseline Characteristics were done in the Safety Analysis Set.
|
||||
|
Race/Ethnicity, Customized
[1] Measure Type: Number Unit of measure: Participants |
||||
| Black or African American | Number Analyzed | 309 participants | 310 participants | 619 participants |
| 1 | 0 | 1 | ||
| White | Number Analyzed | 309 participants | 310 participants | 619 participants |
| 298 | 299 | 597 | ||
| Missing | Number Analyzed | 309 participants | 310 participants | 619 participants |
| 10 | 11 | 21 | ||
|
[1]
Measure Analysis Population Description: The Demographic and Baseline Characteristics were done in the Safety Analysis Set.
|
||||
Outcome Measures
Adverse Events