Heart Failure, SystolicPROVIDE-HFNCT03387163
Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
An observational study of Heart Failure, Systolic, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
Real-world evidence of the clinical course of patient symptoms following initiation of sacubitril/valsartan via PROs with a patient-centered study design will provide important evidence of potentially beneficial outcomes associated with the use of this therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Sacubitril/Valsartan
- How many people
- 402 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2018to 21 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 400 adult patients with chronic systolic HF in PCORnet. We will focus on chronic systolic HF patients initiated on sacubitril/valsartan and a comparator group not initiated on sacubitril/valsartan sacubitril (but with background ACE/ARB therapy and recent titration of these medications).
Who may be able to join
- Diagnosis of chronic systolic HF
- Active care by a provider in a healthcare system connected to a PCORnet data partner
- Ability to speak and read English (given the use of the English ePRO technology)
- Newly initiating sacubitril/valsartan (observational sacubitril/valsartan treatment group only - within 1 week of first dose)
- At least a 25% change ACE/ARB dose (including increase and decrease; or initiation or medication switching to another ACEI/ARB) in the last 6 months (comparator group only)
- Reliable access to the internet
Who cannot join
- Inability to provide informed consent
- Life expectancy < 6 months
- For comparator group patients: Physician documentation of planned initiation of sacubitril/valsartan within 12 weeks
- Other protocol inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
New York, New York, 10029
About this study
Official title: PROVIDE-HF: Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
Real-world evidence of the clinical course of patient symptoms following initiation of sacubitril/valsartan via PROs with a patient-centered study design will provide important evidence of potentially beneficial outcomes associated with the use of this therapy.
Read the detailed description
This is a prospective cohort study of 400 chronic HF patients that will also examine and describe retrospective electronic health record data. We will use the PCORnet (Patient Centered Outcomes Research Network, see "data sources" below) infrastructure to (1) identify a cohort of chronic systolic HF patients initiated on sacubitril/valsartan (N=200) as well as a comparator group of similar HF patients not initiated on sacubitril/valsartan (N=200) but with background ACE/ARB therapy and (2) evaluate baseline and follow-up PROs via an electronic patient reported outcomes (ePRO) form in the eCOS database for 12 weeks.
- Conditions
- Heart Failure, Systolic
- Being tested
- Sacubitril/Valsartan
- Keywords
- Heart failure, Reduced left ventricular ejection fraction, Chronic Systolic Heart failure, Sacubitril /Valsartan, Patient reported outcomes (PRO), Kansas City Cardiomyopathy Questionnaire (KCCQ), Patient Centered Outcomes Research Network (PCORNeT), Common Data Model (CDM)
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril/ValsartanDrug
commercially available Sacubitril/Valsartan: 24/26; 49/51 ; 97/103
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril/Valsartan | Chronic systolic heart failure patients newly prescribed in mg. twice daily. Receives: Drug: Sacubitril/Valsartan | |
| ACEi/ARB | Chronic systolic heart failure patients receiving ACEi/ARB and no s/v |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 12 weeks in the KCCQ
Kansas City Cardiomyopathy Questionnaire (KCCQ) - self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life in patients with heart failure.
Measured: Baseline to weeks 2, 4, 8 and 12
Secondary outcomes (1)
Responder analysis for a 5-point improvement in KCCQ to week 12
Binary response for a 5-point improvement in KCCQ to week 12
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start9 Feb 2018
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, SystolicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 402 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
- NCT03387163
- Sponsor's protocol ID
- CLCZ696BUS17
- Acronym
- PROVIDE-HF
- Status last verified
- Dec 2019
- First submitted
- 21 Dec 2017
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Publications
Mentz RJ, Xu H, O'Brien EC, Thomas L, Alexy T, Gupta B, Vilaro J, Lala A, DeVore AD, Dhingra R, Briasoulis A, Simon MA, Stehlik J, Rodgers JE, Dunlay SM, Abshire M, Wells QS, Barringhaus KG, Eckman PM, Lowes BD, Espinoza J, Blanco R, Shen X, Duffy CI, Hernandez AF. PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure. Am Heart J. 2020 Dec;230:35-43. doi: 10.1016/j.ahj.2020.09.012. Epub 2020 Sep 24.
PubMed 32980364
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROVIDE-HF: Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
- ClinicalTrials.gov ID
- NCT03387163
- Acronym / sponsor ID
- PROVIDE-HF / CLCZ696BUS17
- Conditions
- Heart Failure, Systolic
- Keywords
- Heart failure, Reduced left ventricular ejection fraction, Chronic Systolic Heart failure, Sacubitril /Valsartan, Patient reported outcomes (PRO), Kansas City Cardiomyopathy Questionnaire (KCCQ), Patient Centered Outcomes Research Network (PCORNeT), Common Data Model (CDM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Real-world evidence of the clinical course of patient symptoms following initiation of sacubitril/valsartan via PROs with a patient-centered study design will provide important evidence of potentially beneficial outcomes associated with the use of this therapy.
Detailed description
This is a prospective cohort study of 400 chronic HF patients that will also examine and describe retrospective electronic health record data. We will use the PCORnet (Patient Centered Outcomes Research Network, see "data sources" below) infrastructure to (1) identify a cohort of chronic systolic HF patients initiated on sacubitril/valsartan (N=200) as well as a comparator group of similar HF patients not initiated on sacubitril/valsartan (N=200) but with background ACE/ARB therapy and (2) evaluate baseline and follow-up PROs via an electronic patient reported outcomes (ePRO) form in the eCOS database for 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/Valsartan | – | Drug: Sacubitril/ValsartanChronic systolic heart failure patients newly prescribed in mg. twice daily. |
| ACEi/ARB | – | –Chronic systolic heart failure patients receiving ACEi/ARB and no s/v |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 400 adult patients with chronic systolic HF in PCORnet. We will focus on chronic systolic HF patients initiated on sacubitril/valsartan and a comparator group not initiated on sacubitril/valsartan sacubitril (but with background ACE/ARB therapy and recent titration of these medications).
Key inclusion criteria (6 listed)
- Diagnosis of chronic systolic HF
- Active care by a provider in a healthcare system connected to a PCORnet data partner
- Ability to speak and read English (given the use of the English ePRO technology)
- Newly initiating sacubitril/valsartan (observational sacubitril/valsartan treatment group only - within 1 week of first dose)
- At least a 25% change ACE/ARB dose (including increase and decrease; or initiation or medication switching to another ACEI/ARB) in the last 6 months (comparator group only)
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Life expectancy < 6 months
- For comparator group patients: Physician documentation of planned initiation of sacubitril/valsartan within 12 weeks
- Other protocol inclusion/exclusion criteria may apply
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/Valsartancommercially available Sacubitril/Valsartan: 24/26; 49/51 ; 97/103 | Drug | Sacubitril/Valsartan |
Primary outcome
Change from baseline to 12 weeks in the KCCQ
Time frame: Baseline to weeks 2, 4, 8 and 12
Kansas City Cardiomyopathy Questionnaire (KCCQ) - self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life in patients with heart failure.
1 secondary outcome
Responder analysis for a 5-point improvement in KCCQ to week 12
Time frame: Baseline to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Derived from this study: PubMed 32980364Mentz RJ, Xu H, O'Brien EC, Thomas L, Alexy T, Gupta B, Vilaro J, Lala A, DeVore AD, Dhingra R, Briasoulis A, Simon MA, Stehlik J, Rodgers JE, Dunlay SM, Abshire M, Wells QS, Barringhaus KG, Eckman PM, Lowes BD, Espinoza J, Blanco R, Shen X, Duffy CI, Hernandez AF. PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure. Am Heart J. 2020 Dec;230:35-43. doi: 10.1016/j.ahj.2020.09.012. Epub 2020 Sep 24.
- Individual participant dataSharing planned: Undecided. 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
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Systolic, run by Novartis Pharmaceuticals at 1 site 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 4 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 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline to 12 weeks in the KCCQ (time frame: Baseline to weeks 2, 4, 8 and 12). 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 NCT03387163, 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 13 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.