Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-01-03 @ 5:53 AM
Study NCT ID:
NCT02807857
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2016-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREFER
Brief 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..
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-000473-20 | EUDRACT_NUMBER | None | View |