A prospective evaluation of natriuretic peptide based referral of CHF patients in primary care - PREFER

ovartis Pharma services AG0 sites1,415 target enrollmentDecember 15, 2016

Overview

No summary available.

Registry

who.int

Start Date

December 15, 2016

End Date

March 23, 2018

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•\- Willing and able to provide written informed consent and accept study procedures and time schedule.
•\- Age \= 18 years.
•\- Patients suffering from chronic heart failure whose diagnosis has been made or confirmed by a cardiologist and/or hospital physician.
•\- Patients with reduced ejection fraction (LVEF \= 40%).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 1600
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 2400

•\- Use of investigational drugs within 5 half\-lives of enrollment, or within 30 days /until the expected pharmacodynamic effect has returned to baseline.
•\- Major surgery in the last 3 months or planned/foreseeable major surgery or cardiac intervention during the study.
•\- Cancer or other significant co\-morbidities implying that the patient’s condition is unstable.
•\- Comorbidities that can be associated with elevated natriuretic peptide (NP) levels, recent (less than 3 months) cerebral trauma or recent (less than 3 months) cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the last 3 months.
•\- Patients who are primarily managed and regularly followed\-up by a cardiologist for their HF.
•\- Highly frail patients whose estimated lifespan due to comorbidities is less than 6 months.