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randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure (OUTSTEP-HF)

Primary Purpose

Chronic Heart Failure With Reduced Ejection Fraction

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

LCZ696 (Sacubitril/Valsartan)

Placebo of LCZ696 (Sacubitril/Valsartan)

Enalapril

Placebo of Enalapril

About this trial

This is an interventional treatment trial for Chronic Heart Failure With Reduced Ejection Fraction focused on measuring sacubitril/valsartan, enalapril, physical activity, actigraphy, sleep, heart failure, reduced ejection fraction, randomized controlled trial, accelerometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

Written informed consent obtained before any study assessment is performed.
Ambulatory ≥ 18 years of age with a diagnosis of chronic symptomatic HF (NYHA class ≥ II) with reduced ejection fraction, defined as known LVEF ≤ 40%

AND one of the following two criteria:

Plasma NT-proBNP level of ≥ 300 pg/mL or BNP ≥ 100 pg/mL (measurement may be recorded no longer than past 12 months) OR
Confirmation of a heart failure hospitalization last 12 months.
Patients must be on stable HF medication for at least 4 weeks prior to Week - 2, where the minimal daily dose of current evidence based therapies is equivalent to at least 2.5 mg/d enalapril
Willingness to wear the accelerometer wristband continuously for the duration of the trial.
Patients must be living in a setting, allowing them to move about freely and where they are primarily self-responsible for scheduling their sleep and daily activities.

Key Exclusion Criteria:

History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes
Use of sacubitril/valsartan prior to week - 2.
Bedridden patients, or patients with significantly impaired/limited physical activity and/or fatigue due to medical conditions other than HF, such as, but not limited to angina (chest pain at exertion), arthritis, gout, peripheral artery occlusive disease, obstructive or restrictive lung disease, malignant disease, neurological disorders (e.g. Parkinson's or Alzheimer's disease, central and peripheral neuroinflammatory and -degenerative disorders or functional central nervous lesions due to hemodynamic or traumatic incidents), injuries (incl. diabetic foot ulcers) or missing limbs
Patients with palsy, tremor or rigor affecting the non-dominant arm.
Patients with any skin or other condition of the non-dominant arm that would limit the ability to wear the actigraphy device continuously (24h/day) over 14 weeks.
Patients fully depending on a mobility support system, e.g. wheelchair, scooter or walker. Patients are allowed to use a cane as long as this is not used with the non-dominant arm.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LCZ696 (Sacubitril/Valsartan)

Enalapril

Arm Description

After randomization, patients in this arm received LCZ696 (Sacubitril/Valsartan) twice daily and matching placebo of Enalapril depending on the patient's previous ACEI/ARB dose (enalapril equivalent dose) for 2 weeks. Patients could start study medication at dose level 1 (24 mg/26 mg LCZ), 2 (49 mg/51 mg LCZ) or 2a (49 mg/51 mg LCZ) or matching placebo bid. After 2 weeks (visit 3) the doses were up-titrated: patients, who started on dose level 2 or 2a received the target dose of study medication (level 3) at this point. After another 2 weeks (visit 4) all patients were to achieve the target dose of 97 mg/103 mg bid LCZ696(sacubitril/valsartan) and matching placebo, provided no safety and tolerability issues arised during uptitration.

After randomization, patients in this arm received Enalapril twice daily and matching placebo of LCZ696 (Sacubitril/Valsartan) depending on the patient's previous ACEI/ARB for 2 weeks. Patients could start study medication at dose level 1 or 2a or matching placebo bid. After 2 weeks (visit 3) the doses were up-titrated: patients, who started on dose level 2 or 2a received the target dose of study medication (level 3) at this point. After another 2 weeks (visit 4) all patients were to achieve the target dose of 10 mg bid enalapril and matching placebo, provided no safety and tolerability issues arised during uptitration

Outcomes

Primary Outcome Measures

Change From Baseline (Week 0) in the Six Minute Walk Test (6MWT) at End of Study (Week 12)

The impact of LCZ696 (Sacubitril/Valsartan) and Enalapril on functional exercise capacity was measured by the Six Minute Walk Test at 12 weeks. The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway.

Change From Baseline (Week 0) in Mean Daily Non-sedentary Daytime Activity at End of Study (Week 12)

Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; the average number of minutes per day spent in non-sedentary physical activity is being calculated over 14 days before randomization (baseline i.e. week -2 to week 0) and the last 14 days of treatment (i.e. week 10 to week 12).

Secondary Outcome Measures

Number and Percentage of Participants With Improved Performance (>= 30 m) in the Six Minute Walk Test (6MWT) - FAS

The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group.

Number and Percentage of Participants With Improved Performance (>= 30 m) in the Six Minute Walk Test (6MWT) - FAS Subset Without AE/SAE

The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group.

Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked Equal to or Less Than 300 Meters at Baseline - FAS

The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance equal to or less than 300 meters.

Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked Equal to or Less Than 300 Meters at Baseline - FAS Subset Without AE/SAE

Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked 100-450 Meters at Baseline - FAS

Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked 100-450 Meters at Baseline - FAS Subset Without AE/SAE

Change From Baseline (Week 0) in the Six Minute Walk Test (6MWT) at Weeks 4 and 8

The impact of LCZ696 (Sacubitril/Valsartan) and Enalapril on functional exercise capacity was measured by the Six Minute Walk Test at Weeks 4 and 8. The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway.

Number and Percentage of Participants Who Show Increased Levels (>= 10% Increase) of Non Sedentary Daytime Physical Activity at Week 12 Compared to Baseline

Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; the average number of minutes per day spent in non-sedentary physical activity will be calculated over 14 days before randomization (baseline) and the last 14 days of treatment (i.e week 10 to week 12)

Number and Percentage of Participants Achieving PGA Score at Weeks 4, 8 and 12

The Patient Global Assessment (PGA) is a self-reported tool to assess the patients' subjective rating of their disease activity widely used in HF research. The patients are asked to report functioning or response to an intervention by rating their current condition compared to their pre-intervention condition on a numerical scale: 1) much improved 2) moderately improved 3) a little improved 4) unchanged 5) a little worse 6) moderately worse or 7) much worse.

Number and Percentage of Participants With Improved Symptoms of Heart Failure as Assessed by Patient Global Assessment (PGA)

Change From Baseline in Mean Daily Non-sedentary Daytime Activity in Weekly Intervals

Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; Mean daily non-sedentary daytime physical activity were being calculated over weekly and compared to before the inclusion.

Change From Baseline in Mean Daily Non-sedentary Daytime Activity in Two-weekly Intervals

Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; Mean daily non-sedentary daytime physical activity were being calculated over two-weekly intervals and compared to before the inclusion.

Change From Baseline in Mean Daily Light Non-sedentary Daytime Physical Activity

The average number of minutes per day spent in light non-sedentary physical activity was being calculated over 7 day epochs. Non-sedentary physical activity is defined as >= 178.5 activity counts per minute and light physical activity is defined as 178.5 - 565.5 counts per minute.

Change From Baseline in Mean Daily Moderate-to-Vigorous Non-sedentary Daytime Physical Activity

The average number of minutes per day spent in moderate to vigorous non-sedentary physical activity was being calculated over 7 day epochs. Non-sedentary physical activity is defined as >= 178.5 activity counts per minute and moderate-to-vigorous activity is defined as > 565.5 counts per minute.

Total Weekly Time Spent in Non-sedentary Daytime Physical Activity

Non-sedentary physical activity is defined as >= 178.5 activity counts per minute; The total time spent in non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed.

Total Weekly Time Spent in Light Non-sedentary Daytime Physical Activity

Light non-sedentary daytime physical activity is defined as between 178.5 - 565.5 counts per minute; The time spent in light non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed.

Total Weekly Time Spent in Moderate-to-Vigorous Non-sedentary Daytime Physical Activity

Moderate-to-vigorous non-sedentary physical activity is defined as > 565.5 counts per minute. The total time spent in moderate-to-vigorous non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed.

Change From Baseline in Peak Six Minutes of Daytime Physical Activity

The peak 6 min walk (M6min) is a parameter derived by validated algorithms of the software that are used to preprocess actigraphy data. The parameter reflected the peak 6 minutes of day time physical activity. The mean daily 6-minute walking test was being calculated over 14 day intervals.

Full Information

NCT ID

NCT02900378

First Posted

September 9, 2016

Last Updated

September 1, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02900378

Brief Title

randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure

Acronym

OUTSTEP-HF

Official Title

A Multi-center, Prospective, Randomized, Double-blind Study to Assess the Impact of Sacubitril/Valsartan vs. Enalapril on Daily Physical Activity Using a Wrist Worn Actigraphy Device in Adult Chronic Heart Failure Patients

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

December 20, 2016 (Actual)

Primary Completion Date

April 11, 2018 (Actual)

Study Completion Date

April 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in HFrEF patients. Physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure With Reduced Ejection Fraction

Keywords

sacubitril/valsartan, enalapril, physical activity, actigraphy, sleep, heart failure, reduced ejection fraction, randomized controlled trial, accelerometry

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

621 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LCZ696 (Sacubitril/Valsartan)

Arm Type

Experimental

Arm Description

Arm Title

Enalapril

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

LCZ696 (Sacubitril/Valsartan)

Other Intervention Name(s)

LCZ696

Intervention Description

LCZ696 (sacubitril/valsartan) was available in 24 mg/26 mg, 49 mg/51 and 97 mg/103 mg mg film-coated tablets

Intervention Type

Drug

Intervention Name(s)

Placebo of LCZ696 (Sacubitril/Valsartan)

Other Intervention Name(s)

Placebo

Intervention Description

Placebo of LCZ696 (sacubitril/valsartan) was available to match 24 mg/26 mg, 49 mg/51 and 97 mg/103 mg mg film-coated tablets

Intervention Type

Drug

Intervention Name(s)

Enalapril

Intervention Description

Enalapril was available in 2.5 mg, 5 mg and 10 mg film-coated tablets

Intervention Type

Drug

Intervention Name(s)

Placebo of Enalapril

Other Intervention Name(s)

Placebo

Intervention Description

Placebo of Enalapril was available to match 2.5 mg, 5 mg and 10 mg film-coated tablets

Primary Outcome Measure Information:

Title

Change From Baseline (Week 0) in the Six Minute Walk Test (6MWT) at End of Study (Week 12)

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline (Week 0) in Mean Daily Non-sedentary Daytime Activity at End of Study (Week 12)

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Number and Percentage of Participants With Improved Performance (>= 30 m) in the Six Minute Walk Test (6MWT) - FAS

Description

The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group.

Time Frame

Baseline, Week 12

Title

Number and Percentage of Participants With Improved Performance (>= 30 m) in the Six Minute Walk Test (6MWT) - FAS Subset Without AE/SAE

Description

The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group.

Time Frame

Baseline, Week 12

Title

Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked Equal to or Less Than 300 Meters at Baseline - FAS

Description

Time Frame

Baseline, Week 12

Title

Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked Equal to or Less Than 300 Meters at Baseline - FAS Subset Without AE/SAE

Description

Time Frame

Baseline, Week 12

Title

Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked 100-450 Meters at Baseline - FAS

Description

Time Frame

Baseline, Week 12

Title

Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked 100-450 Meters at Baseline - FAS Subset Without AE/SAE

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline (Week 0) in the Six Minute Walk Test (6MWT) at Weeks 4 and 8

Description

Time Frame

Baseline, Week 4 and Week 8

Title

Number and Percentage of Participants Who Show Increased Levels (>= 10% Increase) of Non Sedentary Daytime Physical Activity at Week 12 Compared to Baseline

Description

Time Frame

Baseline, Week 12

Title

Number and Percentage of Participants Achieving PGA Score at Weeks 4, 8 and 12

Description

Time Frame

Week 4, Week 8, Week 12

Title

Number and Percentage of Participants With Improved Symptoms of Heart Failure as Assessed by Patient Global Assessment (PGA)

Description

Time Frame

Week 4, Week 8, Week 12

Title

Change From Baseline in Mean Daily Non-sedentary Daytime Activity in Weekly Intervals

Description

Time Frame

Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12

Title

Change From Baseline in Mean Daily Non-sedentary Daytime Activity in Two-weekly Intervals

Description

Time Frame

Baseline, Weeks 0 to 2, Weeks 2 to 4, Weeks 4 to 6, Weeks 6 to 8, Weeks 8 to 10, Weeks 10 to 12

Title

Change From Baseline in Mean Daily Light Non-sedentary Daytime Physical Activity

Description

Time Frame

Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12

Title

Change From Baseline in Mean Daily Moderate-to-Vigorous Non-sedentary Daytime Physical Activity

Description

Time Frame

Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12

Title

Total Weekly Time Spent in Non-sedentary Daytime Physical Activity

Description

Time Frame

Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12

Title

Total Weekly Time Spent in Light Non-sedentary Daytime Physical Activity

Description

Time Frame

Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12

Title

Total Weekly Time Spent in Moderate-to-Vigorous Non-sedentary Daytime Physical Activity

Description

Time Frame

Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12

Title

Change From Baseline in Peak Six Minutes of Daytime Physical Activity

Description

Time Frame

Baseline, Week 2, Week 4, Week 6, Week 8 and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Written informed consent obtained before any study assessment is performed. Ambulatory ≥ 18 years of age with a diagnosis of chronic symptomatic HF (NYHA class ≥ II) with reduced ejection fraction, defined as known LVEF ≤ 40% AND one of the following two criteria: Plasma NT-proBNP level of ≥ 300 pg/mL or BNP ≥ 100 pg/mL (measurement may be recorded no longer than past 12 months) OR Confirmation of a heart failure hospitalization last 12 months. Patients must be on stable HF medication for at least 4 weeks prior to Week - 2, where the minimal daily dose of current evidence based therapies is equivalent to at least 2.5 mg/d enalapril Willingness to wear the accelerometer wristband continuously for the duration of the trial. Patients must be living in a setting, allowing them to move about freely and where they are primarily self-responsible for scheduling their sleep and daily activities. Key Exclusion Criteria: History of hypersensitivity to any of the study drugs or their excipients or to drugs of similar chemical classes Use of sacubitril/valsartan prior to week - 2. Bedridden patients, or patients with significantly impaired/limited physical activity and/or fatigue due to medical conditions other than HF, such as, but not limited to angina (chest pain at exertion), arthritis, gout, peripheral artery occlusive disease, obstructive or restrictive lung disease, malignant disease, neurological disorders (e.g. Parkinson's or Alzheimer's disease, central and peripheral neuroinflammatory and -degenerative disorders or functional central nervous lesions due to hemodynamic or traumatic incidents), injuries (incl. diabetic foot ulcers) or missing limbs Patients with palsy, tremor or rigor affecting the non-dominant arm. Patients with any skin or other condition of the non-dominant arm that would limit the ability to wear the actigraphy device continuously (24h/day) over 14 weeks. Patients fully depending on a mobility support system, e.g. wheelchair, scooter or walker. Patients are allowed to use a cane as long as this is not used with the non-dominant arm.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Edegem

State/Province

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novartis Investigative Site

City

Dendermonde

ZIP/Postal Code

9200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Geel

ZIP/Postal Code

2440

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Turnhout

ZIP/Postal Code

2300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1709

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

60200

Country

Czechia

Facility Name

Novartis Investigative Site

City

Chomutov

State/Province

Czech Republic

ZIP/Postal Code

43001

Country

Czechia

Facility Name

Novartis Investigative Site

City

Svitavy

State/Province

Czech Republic

ZIP/Postal Code

568 25

Country

Czechia

Facility Name

Novartis Investigative Site

City

Most

State/Province

CZE

ZIP/Postal Code

434 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Kolin

ZIP/Postal Code

280 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

106 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 5

ZIP/Postal Code

150 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Helsingoer

ZIP/Postal Code

DK-3000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Odense C

ZIP/Postal Code

DK 5000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Randers

ZIP/Postal Code

8930

Country

Denmark

Facility Name

Novartis Investigative Site

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Svendborg

ZIP/Postal Code

5700

Country

Denmark

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

Novartis Investigative Site

City

Hameenlinna

ZIP/Postal Code

13100

Country

Finland

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Novartis Investigative Site

City

Auxerre

ZIP/Postal Code

89000

Country

France

Facility Name

Novartis Investigative Site

City

Clermont-Ferrand Cedex 1

ZIP/Postal Code

63003

Country

France

Facility Name

Novartis Investigative Site

City

Metz Tessy

ZIP/Postal Code

74370

Country

France

Facility Name

Novartis Investigative Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01099

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Homburg

ZIP/Postal Code

61348

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13055

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Buchholz in der Nordheide

ZIP/Postal Code

21244

Country

Germany

Facility Name

Novartis Investigative Site

City

Dietzenbach

ZIP/Postal Code

63128

Country

Germany

Facility Name

Novartis Investigative Site

City

Elsterwerda

ZIP/Postal Code

04910

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45355

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60594

Country

Germany

Facility Name

Novartis Investigative Site

City

Halberstadt

ZIP/Postal Code

38820

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22041

Country

Germany

Facility Name

Novartis Investigative Site

City

Hassloch

ZIP/Postal Code

67454

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Loehne

ZIP/Postal Code

32584

Country

Germany

Facility Name

Novartis Investigative Site

City

Mannheim

ZIP/Postal Code

68165

Country

Germany

Facility Name

Novartis Investigative Site

City

Muehldorf

ZIP/Postal Code

84453

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuremberg

ZIP/Postal Code

90402

Country

Germany

Facility Name

Novartis Investigative Site

City

Reinfeld

ZIP/Postal Code

23858

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwaebisch Hall

ZIP/Postal Code

74523

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57 072

Country

Germany

Facility Name

Novartis Investigative Site

City

Wallerfing

ZIP/Postal Code

94574

Country

Germany

Facility Name

Novartis Investigative Site

City

Wedel

ZIP/Postal Code

22880

Country

Germany

Facility Name

Novartis Investigative Site

City

Wermsdorf

ZIP/Postal Code

04779

Country

Germany

Facility Name

Novartis Investigative Site

City

Alexandroupolis

State/Province

Evros

ZIP/Postal Code

681 00

Country

Greece

Facility Name

Novartis Investigative Site

City

Voula

State/Province

ZIP/Postal Code

166 73

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

151 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion Crete

ZIP/Postal Code

711 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Kopavogur

ZIP/Postal Code

201

Country

Iceland

Facility Name

Novartis Investigative Site

City

Reykjavik

ZIP/Postal Code

IS-101

Country

Iceland

Facility Name

Novartis Investigative Site

City

Dublin 7

Country

Ireland

Facility Name

Novartis Investigative Site

City

Jelgava

ZIP/Postal Code

3001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Ogre

ZIP/Postal Code

5001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

1012

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV 1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1001

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

LTU

ZIP/Postal Code

LT 50161

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

State/Province

LTU

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Goes

ZIP/Postal Code

4462 RA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Haarlem

ZIP/Postal Code

2035 RC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Heerlen

ZIP/Postal Code

6419

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leiderdorp

ZIP/Postal Code

2353 GA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Roermond

ZIP/Postal Code

6043 CV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Veldhoven

ZIP/Postal Code

5504 DB

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Feiring

ZIP/Postal Code

2093

Country

Norway

Facility Name

Novartis Investigative Site

City

Lodz

State/Province

Lodzkie

ZIP/Postal Code

91425

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-676

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

05077

Country

Poland

Facility Name

Novartis Investigative Site

City

Ferrol

State/Province

A Coruna

ZIP/Postal Code

15405

Country

Spain

Facility Name

Novartis Investigative Site

City

Elche

State/Province

Alicante

ZIP/Postal Code

03293

Country

Spain

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Granada

State/Province

Andalucia

ZIP/Postal Code

18014

Country

Spain

Facility Name

Novartis Investigative Site

City

Huelva

State/Province

Andalucia

ZIP/Postal Code

21005

Country

Spain

Facility Name

Novartis Investigative Site

City

Sanlúcar de Barrameda

State/Province

Andalucia

ZIP/Postal Code

11540

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Gijon

State/Province

Asturias

ZIP/Postal Code

33290

Country

Spain

Facility Name

Novartis Investigative Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33011

Country

Spain

Facility Name

Novartis Investigative Site

City

Villamartin

State/Province

Cadiz

ZIP/Postal Code

11650

Country

Spain

Facility Name

Novartis Investigative Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novartis Investigative Site

City

Aranda de Duero

State/Province

Castilla Y Leon

ZIP/Postal Code

09400

Country

Spain

Facility Name

Novartis Investigative Site

City

Burgos

State/Province

Castilla Y Leon

ZIP/Postal Code

09006

Country

Spain

Facility Name

Novartis Investigative Site

City

Leon

State/Province

Castilla Y Leon

ZIP/Postal Code

24071

Country

Spain

Facility Name

Novartis Investigative Site

City

Soria

State/Province

Castilla Y Leon

ZIP/Postal Code

42005

Country

Spain

Facility Name

Novartis Investigative Site

City

Sabadell

State/Province

Cataluña

ZIP/Postal Code

08208

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03010

Country

Spain

Facility Name

Novartis Investigative Site

City

Caceres

State/Province

Extremadura

ZIP/Postal Code

10003

Country

Spain

Facility Name

Novartis Investigative Site

City

Lugo

State/Province

Galicia

ZIP/Postal Code

27003

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Manises

State/Province

Valencia

ZIP/Postal Code

46940

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Novartis Investigative Site

City

Lund

ZIP/Postal Code

222 21

Country

Sweden

Facility Name

Novartis Investigative Site

City

Molndal

ZIP/Postal Code

431 80

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockton on Tees

State/Province

Cleveland

ZIP/Postal Code

TS19 8PE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Rothwell

State/Province

GBR

ZIP/Postal Code

NN14 6JQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Faringdon

State/Province

Oxfordshire

ZIP/Postal Code

SN7 7YU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Gateshead

State/Province

Tyne And Wear

ZIP/Postal Code

NE9 6SX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bournemouth

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cumbria

ZIP/Postal Code

CA139HT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Poole

ZIP/Postal Code

BH15 2JB

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wellingborough

ZIP/Postal Code

NN8 4RW

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Learn more about this trial

randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure

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randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure (OUTSTEP-HF)

Chronic Heart Failure With Reduced Ejection Fraction

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial