Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.
NCT ID: NCT02970669
Last Updated: 2021-10-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
140 participants
INTERVENTIONAL
2016-12-16
2018-03-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
LCZ696 Compared to Valsartan in Patients With Chronic Heart Failure and Preserved Left-ventricular Ejection Fraction
NCT00887588
Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction
NCT02884206
Differential Vascular and Endocrine Effects of Valsartan/Sacubitril in Heart Failure With Reduced Ejection Fraction
NCT03168568
Sodium Excretion of LCZ696 in Patients With Hypertension; Heart Failure and Healthy Volunteers
NCT01353508
Efficacy and Safety of Valsartan Versus Placebo on Exercise Tolerance in Patients With Heart Failure
NCT00171106
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Enalapril
Double blind treatment epoch: Patients randomized to this arm received 1 tablet of enalapril and 1 tablet of matching placebo sacubitril/valsartan twice daily for 8 weeks. All Patients began the study on Dose Level 1 (i.e. 2.5 mg enalapril BID). Patients may have been sequentially up-titrated to achieve desired dose of Dose Level 3 (i.e. 10 mg enalapril BID). Patients not tolerating dose escalation could have been titrated down to next lower dose level.
Open-label treatment epoch: All patients entering this epoch (8 weeks) were given sacubitril/valsartan 49/51 mg BID (Dose Level 2) unless they completed the double-blind treatment epoch on enalapril Dose Level 1. Instead, these patients entered open-label epoch on Dose Level 1 of sacubitril/valsartan. Patients may have been sequentially up-titrated to achieve desired dose of Dose Level 3 of sacubitril/valsartan. Patients not tolerating dose escalation could have been titrated down to next lower dose level.
sacubitril/valsartan (LCZ696)
sacubitril/valsartan tablet taken orally.
enalapril
Enalapril tablet taken orally.
matching placebo sacubitril/valsartan (LCZ696)
matching placebo sacubitril/valsartan tablet taken orally
Sacubitril/Valsartan
Double blind treatment epoch: Patients randomized to this arm received 1 tablet of sacubitril/valsartan and 1 tablet of matching placebo enalapril twice daily for 8 weeks. All Patients began the study on Dose Level 1 (i.e. 24/26 mg sacubitril/valsartan BID). Patients may have sequentially been up-titrated to achieve desired dose of Dose Level 3 (i.e. 97/103 mg sacubitril/valsartan BID). Patients not tolerating dose escalation could have been titrated down to next lower dose level.
Open-label treatment epoch: All patients entering this epoch (8 weeks) were given sacubitril/valsartan 49/51 mg BID (Dose Level 2) unless they completed the double-blind treatment epoch on Dose Level 1. Instead, these patients entered open-label epoch on Dose Level 1. Patients may sequentially have been up-titrated to achieve desired dose of Dose Level 3. Patients not tolerating dose escalation could have been titrated down to next lower dose level.
sacubitril/valsartan (LCZ696)
sacubitril/valsartan tablet taken orally.
matching placebo enalapril
matching placebo enalapril tablet taken orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sacubitril/valsartan (LCZ696)
sacubitril/valsartan tablet taken orally.
enalapril
Enalapril tablet taken orally.
matching placebo sacubitril/valsartan (LCZ696)
matching placebo sacubitril/valsartan tablet taken orally
matching placebo enalapril
matching placebo enalapril tablet taken orally
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Men and women between 18 and 80 years of age
* Subjects diagnosed with NYHA class II or III heart failure and with reduced ejection (HFrEF).
(Reduced ejection is defined as left ventricular EF ≤ 40%. LVEF ≤40% may be determined via any local measurement within the past 6 months prior to signing consent, using echocardiography, multi gated acquisition scan (MUGA), CT scanning, MRI or ventricular angiography provided no subsequent study documenting an EF of \>40%. If the EF measurement is expressed as a value range, the average of the range endpoint values should be used as the EF).
* Subjects must be a candidate for treatment with sacubitril/valsartan as per USPI.
* Subjects must be living in a traditional residence, apartment, or non-communal adult home where they can move about freely and frequently and are primarily responsible for scheduling their sleep and daily activities.
Exclusion Criteria
* Subjects with a history of angioedema drug related or otherwise
* Subjects with symptomatic hypotension or systolic blood pressure \<100 mmHg at screening or \<95 mmHg at randomization
* Subjects with any conditions in skin or upper extremities which would limit the ability to tolerate a wrist-worn actigraphy device on the non-dominant arm for 24 hours/day for the duration of the study.
* Subjects who are non-ambulatory or use mobility assistive devices such as motorized devices, wheelchairs, or walkers. The use of canes for stability while ambulating is acceptable.
* Subjects with physical activity impairment primarily due to conditions other than heart failure such as:
* Exertional angina inflammatory or degenerative joint disease -gout
* peripheral vascular disease
* neurologic disease affecting activity or mobility
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Fort Payne, Alabama, United States
Novartis Investigative Site
Beverly Hills, California, United States
Novartis Investigative Site
Stockton, California, United States
Novartis Investigative Site
West Hills, California, United States
Novartis Investigative Site
Doral, Florida, United States
Novartis Investigative Site
Inverness, Florida, United States
Novartis Investigative Site
Ormond Beach, Florida, United States
Novartis Investigative Site
Port Orange, Florida, United States
Novartis Investigative Site
Lutherville, Maryland, United States
Novartis Investigative Site
East Brunswick, New Jersey, United States
Novartis Investigative Site
Ridgewood, New Jersey, United States
Novartis Investigative Site
Columbia, South Carolina, United States
Novartis Investigative Site
Greenville, South Carolina, United States
Novartis Investigative Site
Lancaster, South Carolina, United States
Novartis Investigative Site
Allen, Texas, United States
Novartis Investigative Site
McKinney, Texas, United States
Novartis Investigative Site
New Braunfels, Texas, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
San Marcos, Texas, United States
Novartis Investigative Site
Sherman, Texas, United States
Novartis Investigative Site
Tomball, Texas, United States
Novartis Investigative Site
Midlothian, Virginia, United States
Novartis Investigative Site
Tacoma, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Khandwalla RM, Grant D, Birkeland K, Heywood JT, Fombu E, Owens RL, Steinhubl SR; AWAKE-H. F. Study Investigators. The AWAKE-HF Study: Sacubitril/Valsartan Impact on Daily Physical Activity and Sleep in Heart Failure. Am J Cardiovasc Drugs. 2021 Mar;21(2):241-254. doi: 10.1007/s40256-020-00440-y. Epub 2020 Sep 26.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
A Plain Language Trial Summary is available on novartisclinicaltrials.com
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLCZ696BUS14
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.