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Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure (PROVIDE-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03387163
Recruitment Status : Completed
First Posted : December 29, 2017
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment
Heart Failure, Systolic Drug: Sacubitril/Valsartan

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.

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Study Type : Observational
Actual Enrollment : 402 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: PROVIDE-HF: Patient Reported Outcomes inVestigation Following Initiation of Drug Therapy With Entresto (Sacubitril/Valsartan) in Heart Failure
Actual Study Start Date : February 9, 2018
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : June 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Sacubitril/Valsartan
Chronic systolic heart failure patients newly prescribed in mg. twice daily.
Drug: Sacubitril/Valsartan
commercially available Sacubitril/Valsartan: 24/26; 49/51 ; 97/103

ACEi/ARB
Chronic systolic heart failure patients receiving ACEi/ARB and no s/v



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Responder analysis for a 5-point improvement in KCCQ to week 12 [ Time Frame: Baseline to week 12 ]
    Binary response for a 5-point improvement in KCCQ to week 12



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria

  • 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

Exclusion criteria:

  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387163


Locations
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United States, New York
Novartis Investigative Site
New York, New York, United States, 10029
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03387163    
Other Study ID Numbers: CLCZ696BUS17
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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)
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Valsartan
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action