PROVIDE-HF: Patient Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (Sacubitril/Valsartan) in Heart Failure

The PARADIGM-HF trial demonstrated the superiority of sacubitril/valsartan on clinical outcomes compared with the standard of care ACE-inhibitor enalapril in patients with heart failure with reduced ejection fraction (HFrEF). Sacubitril/valsartan also had more favorable effects on the symptoms and physical limitations of heart failure as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) - a self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life in patients with heart failure. Scores on the KCCQ range from 0 to 100, with higher scores indicating fewer symptoms and physical limitations associated with heart failure. 

Evaluation of symptom change by patients is characterized as a Patient-Reported Outcome (PRO). PROs are an important component of assessing whether care provided by clinicians improves patients' health. Due to a growing emphasis on patient-centered care and value-based payment, PROs will play a prominent role in the assessment of the comparative effectiveness of different treatments. There is also an increasing interest in enhancing patient engagement in the development, execution and dissemination of clinical research studies that have a patient-centered and patient-focused perspective.

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 use of this therapy. 

• Primary objective: To investigate the change in patient-reported HF symptoms via the KCCQ following the initiation of sacubitril/valsartan (continuous measure) through 12 weeks.
• Secondary objective: To investigate the change in KCCQ following the initiation of sacubitril/valsartan by a responder analysis (binary response for a 5-point improvement in KCCQ to week 12). 
• Exploratory objectives: 
  • Change in KCCQ during additional relevant timepoints - from baseline to week 2, week 4, and week 8. 
  • Rate of change of KCCQ
  • To examine and describe the patient experience via clinical indicators (hospitalizations, ER visit, clinic visits, diagnostic testing, procedures [for post-baseline assessments]), healthcare resources utilization (HRU), and medication dose for sacubitril/valsartan and comparator patients during the following time periods
    • The 12 months prior to baseline assessment
    • The first 4 weeks post-baseline assesment
    • The 12 weeks pre- and 12 weeks post-baseline assessment

Other Information: 

• Principal Investigator: Bhanu Gupta, MD, MS; University of Kansas Medical Center
• Participating GPC Sites:
  • University of Kansas Medical Center
  • University of Iowa
  • University of Minnesota
  • University of Nebraska Medical Center
  • University of Wisconsin - Madison

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