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

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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Drug: LCZ696 (Sacubitril/Valsartan); Drug: Placebo of Enalapril; Drug: Placebo of LCZ696 (Sacubitril/Valsartan); Drug: Enalapril

• Study Type: Interventional
• Enrollment (Actual): 621
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Dendermonde, Belgium, 9200
    • Novartis Investigative Site
  • Geel, Belgium, 2440
    • Novartis Investigative Site
  • Gent, Belgium, 9000
    • Novartis Investigative Site
  • Turnhout, Belgium, 2300
    • Novartis Investigative Site
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Novartis Investigative Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Novartis Investigative Site
  • Plovdiv, Bulgaria, 4000
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1233
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1606
    • Novartis Investigative Site
  • Sofia, Bulgaria, 1709
    • Novartis Investigative Site
• Czechia
  • Kolin, Czechia, 280 20
    • Novartis Investigative Site
  • Praha 10, Czechia, 106 00
    • Novartis Investigative Site
  • Praha 5, Czechia, 150 00
    • Novartis Investigative Site
  • CZE
    • Most, CZE, Czechia, 434 01
      • Novartis Investigative Site
  • Czech Republic
    • Brno, Czech Republic, Czechia, 60200
      • Novartis Investigative Site
    • Chomutov, Czech Republic, Czechia, 43001
      • Novartis Investigative Site
    • Svitavy, Czech Republic, Czechia, 568 25
      • Novartis Investigative Site
• Denmark
  • Helsingoer, Denmark, DK-3000
    • Novartis Investigative Site
  • Odense C, Denmark, DK 5000
    • Novartis Investigative Site
  • Randers, Denmark, 8930
    • Novartis Investigative Site
  • Roskilde, Denmark, 4000
    • Novartis Investigative Site
  • Svendborg, Denmark, 5700
    • Novartis Investigative Site
• Estonia
  • Tallinn, Estonia, 13419
    • Novartis Investigative Site
  • Tallinn, Estonia, 10138
    • Novartis Investigative Site
  • Tartu, Estonia, 51014
    • Novartis Investigative Site
• Finland
  • Hameenlinna, Finland, 13100
    • Novartis Investigative Site
  • Tampere, Finland, 33520
    • Novartis Investigative Site
• France
  • Auxerre, France, 89000
    • Novartis Investigative Site
  • Clermont-Ferrand Cedex 1, France, 63003
    • Novartis Investigative Site
  • Metz Tessy, France, 74370
    • Novartis Investigative Site
• Germany
  • Bad Homburg, Germany, 61348
    • Novartis Investigative Site
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Berlin, Germany, 10787
    • Novartis Investigative Site
  • Berlin, Germany, 10789
    • Novartis Investigative Site
  • Berlin, Germany, 13055
    • Novartis Investigative Site
  • Buchholz in der Nordheide, Germany, 21244
    • Novartis Investigative Site
  • Dietzenbach, Germany, 63128
    • Novartis Investigative Site
  • Elsterwerda, Germany, 04910
    • Novartis Investigative Site
  • Essen, Germany, 45355
    • Novartis Investigative Site
  • Frankfurt, Germany, 60594
    • Novartis Investigative Site
  • Halberstadt, Germany, 38820
    • Novartis Investigative Site
  • Hamburg, Germany, 22041
    • Novartis Investigative Site
  • Hassloch, Germany, 67454
    • Novartis Investigative Site
  • Leipzig, Germany, 04103
    • Novartis Investigative Site
  • Loehne, Germany, 32584
    • Novartis Investigative Site
  • Mannheim, Germany, 68165
    • Novartis Investigative Site
  • Muehldorf, Germany, 84453
    • Novartis Investigative Site
  • Nuremberg, Germany, 90402
    • Novartis Investigative Site
  • Reinfeld, Germany, 23858
    • Novartis Investigative Site
  • Schwaebisch Hall, Germany, 74523
    • Novartis Investigative Site
  • Siegen, Germany, 57 072
    • Novartis Investigative Site
  • Wallerfing, Germany, 94574
    • Novartis Investigative Site
  • Wedel, Germany, 22880
    • Novartis Investigative Site
  • Wermsdorf, Germany, 04779
    • Novartis Investigative Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01099
      • Novartis Investigative Site
• Greece
  • Athens, Greece, 115 27
    • Novartis Investigative Site
  • Athens, Greece, 151 27
    • Novartis Investigative Site
  • Heraklion Crete, Greece, 711 10
    • Novartis Investigative Site
  • Evros
    • Alexandroupolis, Evros, Greece, 681 00
      • Novartis Investigative Site
  • GR
    • Voula, GR, Greece, 166 73
      • Novartis Investigative Site
• Iceland
  • Kopavogur, Iceland, 201
    • Novartis Investigative Site
  • Reykjavik, Iceland, IS-101
    • Novartis Investigative Site
• Ireland
  • Dublin 7, Ireland
    • Novartis Investigative Site
• Latvia
  • Jelgava, Latvia, 3001
    • Novartis Investigative Site
  • Ogre, Latvia, 5001
    • Novartis Investigative Site
  • Riga, Latvia, LV 1002
    • Novartis Investigative Site
  • Riga, Latvia, 1012
    • Novartis Investigative Site
  • Riga, Latvia, LV-1001
    • Novartis Investigative Site
• Lithuania
  • Vilnius, Lithuania, LT-08661
    • Novartis Investigative Site
  • LTU
    • Kaunas, LTU, Lithuania, LT 50161
      • Novartis Investigative Site
    • Klaipeda, LTU, Lithuania, LT-92288
      • Novartis Investigative Site
• Netherlands
  • Goes, Netherlands, 4462 RA
    • Novartis Investigative Site
  • Haarlem, Netherlands, 2035 RC
    • Novartis Investigative Site
  • Heerlen, Netherlands, 6419
    • Novartis Investigative Site
  • Leiderdorp, Netherlands, 2353 GA
    • Novartis Investigative Site
  • Roermond, Netherlands, 6043 CV
    • Novartis Investigative Site
  • Veldhoven, Netherlands, 5504 DB
    • Novartis Investigative Site
• Norway
  • Feiring, Norway, 2093
    • Novartis Investigative Site
• Poland
  • Warszawa, Poland, 02-097
    • Novartis Investigative Site
  • Warszawa, Poland, 02-507
    • Novartis Investigative Site
  • Warszawa, Poland, 05077
    • Novartis Investigative Site
  • Lodzkie
    • Lodz, Lodzkie, Poland, 91425
      • Novartis Investigative Site
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-676
      • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08041
    • Novartis Investigative Site
  • Girona, Spain, 17007
    • Novartis Investigative Site
  • Madrid, Spain, 28222
    • Novartis Investigative Site
  • Madrid, Spain, 28031
    • Novartis Investigative Site
  • A Coruna
    • Ferrol, A Coruna, Spain, 15405
      • Novartis Investigative Site
  • Alicante
    • Elche, Alicante, Spain, 03293
      • Novartis Investigative Site
  • Andalucia
    • Cordoba, Andalucia, Spain, 14004
      • Novartis Investigative Site
    • Granada, Andalucia, Spain, 18014
      • Novartis Investigative Site
    • Huelva, Andalucia, Spain, 21005
      • Novartis Investigative Site
    • Sanlúcar de Barrameda, Andalucia, Spain, 11540
      • Novartis Investigative Site
    • Sevilla, Andalucia, Spain, 41009
      • Novartis Investigative Site
  • Asturias
    • Gijon, Asturias, Spain, 33290
      • Novartis Investigative Site
    • Oviedo, Asturias, Spain, 33011
      • Novartis Investigative Site
  • Cadiz
    • Villamartin, Cadiz, Spain, 11650
      • Novartis Investigative Site
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Novartis Investigative Site
  • Castilla Y Leon
    • Aranda de Duero, Castilla Y Leon, Spain, 09400
      • Novartis Investigative Site
    • Burgos, Castilla Y Leon, Spain, 09006
      • Novartis Investigative Site
    • Leon, Castilla Y Leon, Spain, 24071
      • Novartis Investigative Site
    • Soria, Castilla Y Leon, Spain, 42005
      • Novartis Investigative Site
  • Cataluña
    • Sabadell, Cataluña, Spain, 08208
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain, 03010
      • Novartis Investigative Site
  • Extremadura
    • Caceres, Extremadura, Spain, 10003
      • Novartis Investigative Site
  • Galicia
    • Lugo, Galicia, Spain, 27003
      • Novartis Investigative Site
    • Santiago de Compostela, Galicia, Spain, 15706
      • Novartis Investigative Site
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Novartis Investigative Site
• Sweden
  • Lund, Sweden, 222 21
    • Novartis Investigative Site
  • Molndal, Sweden, 431 80
    • Novartis Investigative Site
  • Stockholm, Sweden, 17176
    • Novartis Investigative Site
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • Novartis Investigative Site
  • Cumbria, United Kingdom, CA139HT
    • Novartis Investigative Site
  • Poole, United Kingdom, BH15 2JB
    • Novartis Investigative Site
  • Wellingborough, United Kingdom, NN8 4RW
    • Novartis Investigative Site
  • Cleveland
    • Stockton on Tees, Cleveland, United Kingdom, TS19 8PE
      • Novartis Investigative Site
  • GBR
    • Rothwell, GBR, United Kingdom, NN14 6JQ
      • Novartis Investigative Site
  • Oxfordshire
    • Faringdon, Oxfordshire, United Kingdom, SN7 7YU
      • Novartis Investigative Site
  • Tyne And Wear
    • Gateshead, Tyne And Wear, United Kingdom, NE9 6SX
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LCZ696 (Sacubitril/Valsartan); 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.	Drug: LCZ696 (Sacubitril/Valsartan); LCZ696 (sacubitril/valsartan) was available in 24 mg/26 mg, 49 mg/51 and 97 mg/103 mg mg film-coated tablets; Other Names: LCZ696; Drug: Placebo of Enalapril; Placebo of Enalapril was available to match 2.5 mg, 5 mg and 10 mg film-coated tablets; Other Names: Placebo
Active Comparator: Enalapril; 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	Drug: Placebo of LCZ696 (Sacubitril/Valsartan); 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; Other Names: Placebo; Drug: Enalapril; Enalapril was available in 2.5 mg, 5 mg and 10 mg film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 12
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).	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 12
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.	Baseline, Week 12
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.	Baseline, Week 12
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	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.	Baseline, Week 12
Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked 100-450 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 from 100 to 450 meters.	Baseline, Week 12
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	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 from 100 to 450 meters.	Baseline, Week 12
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.	Baseline, Week 4 and Week 8
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)	Baseline, 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.	Week 4, Week 8, Week 12
Number and Percentage of Participants With Improved Symptoms of Heart Failure as Assessed by Patient Global Assessment (PGA)	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. Patients with improved symptoms were categorized as: Improvement, Is unchanged, Gets worse or Missing.	Week 4, Week 8, Week 12
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.	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
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.	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
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.	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
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.	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
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.	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
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.	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
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.	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
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.	Baseline, Week 2, Week 4, Week 6, Week 8 and Week 12

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2016
• Primary Completion (Actual): April 11, 2018
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; randomized controlled trial; sleep; heart failure; enalapril; actigraphy; sacubitril/valsartan; reduced ejection fraction; accelerometry
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Valsartan; Enalaprilat; Enalapril; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: CLCZ696B3301; 2016-003085-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD 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