NCT02807857

A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,415 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.

Detailed description

In the majority of European countries, the primary management of chronic heart failure patients was performed by General Practitioners in collaboration with cardiologists (specialists). Previous studies had shown that many patients suffering from CHF do not receive optimal pharmacological and/or device treatment for their disease. An increase in natriuretic peptides (BNP, NT-proBNP) was associated with increased risk of cardiovascular events in heart failure patients. The purpose of the present study was to assess if a referral of clinical stable chronic heart failure patients with reduced ventricular ejection fraction (EF \< or = 40%) and NT-proBNP level \> or = 600 pg/mL to a specialist (cardiologist) led to treatment optimization, defined as adherence to the treatment recommendations according to the European Society of Cardiology (ESC) guidelines. In addition, data obtained in this study was used to describe demographic, clinical (including NT-proBNP levels) and treatment characteristics of CHF patients who were managed in the primary care setting across Europe..

Conditions

• Chronic Heart Failure (CHF)

Interventions

Type	Name	Description
PROCEDURE	Standard care	Patients will receive the treatment that their primary care physician has decided to prescribe for their disease

Timeline

• Start date: 2016-07-07
• Primary completion: 2018-03-23
• Completion: 2018-03-23
• First posted: 2016-06-21
• Last updated: 2021-02-24
• Results posted: 2021-01-05

Locations

191 sites across 18 countries: Belgium, Croatia, Cyprus, Denmark, Estonia, France, Hungary, Israel, Italy, Latvia, Lithuania, Malta, Norway, Poland, Portugal, Russia, Slovenia, Spain