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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03387163
Other study ID # CLCZ696BUS17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 9, 2018
Est. completion date June 21, 2019

Study information

Verified date December 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 402
Est. completion date June 21, 2019
Est. primary completion date June 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sacubitril/Valsartan
commercially available Sacubitril/Valsartan: 24/26; 49/51 ; 97/103

Locations

Country Name City State
United States Novartis Investigative Site New York New York

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to weeks 2, 4, 8 and 12
Secondary Responder analysis for a 5-point improvement in KCCQ to week 12 Binary response for a 5-point improvement in KCCQ to week 12 Baseline to week 12
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