Heart Failure, Reduced Ejection FractionPhase 4AWAKE-HFNCT02970669
Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.
A Phase 4 study testing sacubitril/valsartan (LCZ696) and enalapril in people with Heart Failure, Reduced Ejection Fraction, run by Novartis Pharmaceuticals at 23 sites in United States.
Trial summary
The purpose of this study was to investigate the effects of initiation of sacubitril/valsartan vs enalapril treatment on objective measures of both waking activity and sleep in subjects with heart failure with reduced ejection fraction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Reduced Ejection Fraction
- What is being tested?
- sacubitril/valsartan (LCZ696) and enalapril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 23 sitesUnited States
- Study dates
- 16 Dec 2016to 19 Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed.
- 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.
Who cannot join
- Subjects with a history of hypersensitivity to any of the study drugs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
- 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:
Show all 9Show fewer
- Exertional angina inflammatory or degenerative joint disease -gout
- peripheral vascular disease
- neurologic disease affecting activity or mobility
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Novartis Investigative Site
Allen, Texas, 75002-3688
Novartis Investigative Site
Beverly Hills, California, 90211
Novartis Investigative Site
Columbia, South Carolina, 29203
Novartis Investigative Site
Doral, Florida, 33126
Novartis Investigative Site
East Brunswick, New Jersey, 08816
Novartis Investigative Site
Fort Payne, Alabama, 35967
Novartis Investigative Site
Greenville, South Carolina, 29615
Novartis Investigative Site
Inverness, Florida, 34452
Novartis Investigative Site
Lancaster, South Carolina, 29720
Novartis Investigative Site
Lutherville, Maryland, 21093
Novartis Investigative Site
McKinney, Texas, 75013
Novartis Investigative Site
Midlothian, Virginia, 23114
Novartis Investigative Site
New Braunfels, Texas, 78130
Novartis Investigative Site
Ormond Beach, Florida, 32174
Novartis Investigative Site
Port Orange, Florida, 32127
Novartis Investigative Site
Ridgewood, New Jersey, 07450
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
San Marcos, Texas, 78666
Novartis Investigative Site
Sherman, Texas, 75092
Novartis Investigative Site
Stockton, California, 95204
Novartis Investigative Site
Tacoma, Washington, 98405
Novartis Investigative Site
Tomball, Texas, 77375
Novartis Investigative Site
West Hills, California, 91307
About this study
Official title: Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled 8-week Study and 8-week Open Label Extension to Evaluate the Effect of Initiation of Sacubitril/Valsartan on Objective Measures of Waking Activity and Sleep, as Health-related Quality of Life Functions in Subjects With Heart Failure and Reduced Ejection Fraction (AWAKE-HF).
The purpose of this study was to investigate the effects of initiation of sacubitril/valsartan vs enalapril treatment on objective measures of both waking activity and sleep in subjects with heart failure with reduced ejection fraction.
- Conditions
- Heart Failure, Reduced Ejection Fraction
- Being tested
- sacubitril/valsartan (LCZ696), enalapril, matching placebo sacubitril/valsartan (LCZ696), matching placebo enalapril
- Keywords
- Heart failure with reduced left ventricular ejection fraction (LVEF), Cardiac dysfunction, Heart muscle dysfunction, Left ventricular (LV) dilation, Left ventricular hypertrophy, HF, AHF, CHF, acute heart failure, chronic heart failure, congestive heart failure, congestive cardiac failure, Heart failure, HReEF, Physical Activity, Actigraphy, Home sleep test, wake
- Medical subject headings
- Heart Failure, Systolic, Dilatation, Pathologic, Hypertrophy, Left Ventricular, Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacubitril/valsartan (LCZ696)Drug
sacubitril/valsartan tablet taken orally.
enalaprilDrug
Enalapril tablet taken orally.
matching placebo sacubitril/valsartan (LCZ696)Drug
matching placebo sacubitril/valsartan tablet taken orally
matching placebo enalaprilDrug
matching placebo enalapril tablet taken orally
| Study group | Role | What they receive |
|---|---|---|
| Enalapril | Active comparator | 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. Receives: Drug: sacubitril/valsartan (LCZ696); Drug: enalapril; Drug: matching placebo sacubitril/valsartan (LCZ696) |
| Sacubitril/Valsartan | Experimental | 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. Receives: Drug: sacubitril/valsartan (LCZ696); Drug: matching placebo enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Mean Activity Counts Collected During the Most Active 30 Minutes of the Subject's Day Between Week 8 and Baseline
The primary endpoint is the ratio in mean activity counts collected during the most active 30 minutes of the subject's day between the final randomized treatment phase measurement (mean of endpoint data collected each day during week 8) and baseline phase (mean of endpoint data collected each day during week -1), as measured by wrist-worn accelerometer collected actigraphy (total counts per 30 min period collected during the most active 30 minutes of each day). A ratio > 1 indicates an increase in mean activity counts from baseline to week 8.
Measured: Baseline, week 8
Secondary outcomes (5)
Change in Mean Activity Counts During Most Active 30 Minutes of Day From Baseline to Week 1
Change in mean activity counts during most active 30 minutes of day from baseline phase (mean of data collected during week -1) to week 1 (mean of data collected during week 1), as measured by actigraphy (total counts per 30 min period collected during the most active 30 minutes of each day).
Measured: Baseline, Week 1
Change in Mean Activity Counts During Most Active 30 Minutes of Day From Baseline to Week 9 and 16
Change in mean activity counts during most active 30 minutes of day from baseline phase (mean of data collected during week -1 for Sacubitril/Valsartan and mean of data collected during week 8 for Enalapril) to week 9 and 16 (mean of data collected during weeks 9 and 16), as measured by actigraphy (total counts per 30 min period collected during the most active 30 minutes of each day).
Measured: Baseline (Sacubitril/Valsartan: week -1/ Enalapril: week 8), week 9 and 16
Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 8
Change in mean activity (counts per minute) during sleep from baseline phase (mean of data collected during week -1) to the final randomized treatment phase measurement (mean of data collected during week 8), as measured by actigraphy (activity counts per minute during daily sleep period, wrist-worn accelerometer).
Measured: Baseline, Week 8
Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 1
Change in mean activity (counts per minute) during sleep from baseline phase (mean of data collected during week -1) to week 1 (mean of data collected during week 1), as measured by actigraphy (activity counts per minute during daily sleep period, wrist-worn accelerometer).
Measured: Baseline, Week 1
Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 9 and 16
Change in mean activity (counts per minute) during sleep from baseline phase (mean of data collected during week -1 for Sacubitril/Valsartan and mean of data collected during week 8 for Enalapril) to week 9 and 16 (mean of data collected during week 9 and 16), as measured by actigraphy (activity counts per minute during daily sleep period, wrist-worn accelerometer).
Measured: Baseline (Sacubitril/Valsartan: week -1 / Enalapril: week 8), week 9 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start16 Dec 2016
- Primary completion19 Mar 2018
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970669
- Sponsor's protocol ID
- CLCZ696BUS14
- Acronym
- AWAKE-HF
- Status last verified
- Oct 2021
- First submitted
- 17 Nov 2016
- Last updated
- 7 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Expanded access
- Available
Publications
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.
PubMed 32978755
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled 8-week Study and 8-week Open Label Extension to Evaluate the Effect of Initiation of Sacubitril/Valsartan on Objective Measures of Waking Activity and Sleep, as Health-related Quality of Life Functions in Subjects With Heart Failure and Reduced Ejection Fraction (AWAKE-HF).
- ClinicalTrials.gov ID
- NCT02970669
- Acronym / sponsor ID
- AWAKE-HF / CLCZ696BUS14
- Conditions
- Heart Failure, Reduced Ejection Fraction
- Keywords
- Heart failure with reduced left ventricular ejection fraction (LVEF), Cardiac dysfunction, Heart muscle dysfunction, Left ventricular (LV) dilation, Left ventricular hypertrophy, HF, AHF, CHF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Posted 8 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate the effects of initiation of sacubitril/valsartan vs enalapril treatment on objective measures of both waking activity and sleep in subjects with heart failure with reduced ejection fraction.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enalapril | Active comparator | Drug: sacubitril/valsartan (LCZ696), Drug: enalapril, Drug: matching placebo sacubitril/valsartan (LCZ696)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 | Experimental | Drug: sacubitril/valsartan (LCZ696), Drug: matching placebo enalaprilDouble 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent must be obtained before any assessment is performed.
- 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.
Key exclusion criteria (9 listed)
- Subjects with a history of hypersensitivity to any of the study drugs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacubitril/valsartan (LCZ696)sacubitril/valsartan tablet taken orally. | Drug | Enalapril, Sacubitril/Valsartan |
| enalaprilEnalapril tablet taken orally. | Drug | Enalapril |
| matching placebo sacubitril/valsartan (LCZ696)matching placebo sacubitril/valsartan tablet taken orally | Drug | Enalapril |
| matching placebo enalaprilmatching placebo enalapril tablet taken orally | Drug | Sacubitril/Valsartan |
Primary outcome
Ratio of Mean Activity Counts Collected During the Most Active 30 Minutes of the Subject's Day Between Week 8 and Baseline
Time frame: Baseline, week 8
The primary endpoint is the ratio in mean activity counts collected during the most active 30 minutes of the subject's day between the final randomized treatment phase measurement (mean of endpoint data collected each day during week 8) and baseline phase (mean of endpoint data collected each day during week -1), as measured by wrist-worn accelerometer collected actigraphy (total counts per 30 min period collected during the most active 30 minutes of each day). A ratio > 1 indicates an increase in mean activity counts from baseline to week 8.
5 secondary outcomes
Change in Mean Activity Counts During Most Active 30 Minutes of Day From Baseline to Week 1
Time frame: Baseline, Week 1
Change in Mean Activity Counts During Most Active 30 Minutes of Day From Baseline to Week 9 and 16
Time frame: Baseline (Sacubitril/Valsartan: week -1/ Enalapril: week 8), week 9 and 16
Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 8
Time frame: Baseline, Week 8
Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 1
Time frame: Baseline, Week 1
Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 9 and 16
Time frame: Baseline (Sacubitril/Valsartan: week -1 / Enalapril: week 8), week 9 and 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32978755Khandwalla 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.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sacubitril/valsartan (LCZ696) and enalapril in people with Heart Failure, Reduced Ejection Fraction, run by Novartis Pharmaceuticals at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of Mean Activity Counts Collected During the Most Active 30 Minutes of the Subject's Day Between Week 8 and Baseline (time frame: Baseline, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.