Evaluation of Heart Failure Treatment Guided by NTproBNP vs Clinical Symptoms and Signs Alone

Condition(s) targeted: Heart Failure; Ventricular Dysfunction, Left

Intervention: Captopril (Drug); Enalapril (Drug); Lisinopril (Drug); Ramipril (Drug); Trandolapril (Drug); Bisoprolol (Drug); Carvedilol (Drug); Metoprolol succinate (Drug); Candesartan (Drug); Valsartan (Drug); Eplerenone (Drug); Spironolactone (Drug); Diuretics (Drug); HF treatment according to Swedish guidelines (Drug); Blood samples (Procedure); KCCQ Questionnaire (Procedure)

Phase: Phase 4

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Sweden Medical Director, MD, Study Director, Affiliation: AstraZeneca
Hans Persson, MD, PhD, Principal Investigator, Affiliation: Danderyd Hospital, Sweden
Bjorn Eriksson, MD, Study Director, Affiliation: AstraZeneca

Overall contact:
AstraZeneca Sweden Clinical Study Information, Phone: +46 8 55326000

The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with HF and left ventricular systolic dysfunction

Official title: A Randomised, Single Blind, Multicentre, 9-Month, Phase IV Study, Comparing Treatment Guided by Clinical Symptoms and Signs and NT-proBNP vs Treatment Guided by Clinical Symptoms and Signs Alone, in Patients With HF and Left Ventricular Systolic Dysfunction

Study design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary variable is a composite endpoint of days alive, days out of hospital and symptoms

Secondary outcome:

Number of deaths

Changes in NTproBNP over time amd related to NYHA class

Changes in KCCQ (overall, symptom score subset, related to NTproBNP)

Changes in HFstatus and vital signs

Number of SAEs

Number of DAEs

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Female/male, over 18 years with previously verified HF with left ventricular systolic

dysfunction.

- NYHA class II-IV,

- NTproBNP males>800 ng/L, females >1000 ng/L

Exclusion Criteria:

- Planned CV hospitalisation, stroke or acute MI last 3 months,

- Mitral/aortic stenosis,

- Patients already receiving optimal HF treatment,

- Severe reduction of kidney function

AstraZeneca Sweden Clinical Study Information, Phone: +46 8 55326000

Research Site, UMEA, Sweden; Recruiting

Research Site, UPPSALA, Sweden; Recruiting

Research Site, VASTERAS, Sweden; Recruiting

Research Site, ALVESTA, Sweden; Recruiting

Research Site, ARVIKA, Sweden; Not yet recruiting

Research Site, BJUV, Sweden; Recruiting

Research Site, BORENSBERG, Sweden; Recruiting

Research Site, BROMMA, Sweden; Recruiting

Research Site, DALBY, Sweden; Recruiting

Research Site, ESKILSTUNA, Sweden; Recruiting

Research Site, GAGNEF, Sweden; Recruiting

Research Site, G�TEBORG, Sweden; Recruiting

Research Site, HISINGS K�RRA, Sweden; Recruiting

Research Site, HUDDINGE, Sweden; Recruiting

Research Site, HUSKVARNA, Sweden; Recruiting

Research Site, J�NK�PING, Sweden; Recruiting

Research Site, KALMAR, Sweden; Recruiting

Research Site, KUNG�LV, Sweden; Recruiting

Research Site, LERUM, Sweden; Recruiting

Research Site, LESSEBO, Sweden; Recruiting

Research Site, LIDK�PING, Sweden; Recruiting

Research Site, LILLA EDET, Sweden; Recruiting

Research Site, LINK�PING, Sweden; Recruiting

Research Site, LUDVIKA, Sweden; Recruiting

Research Site, LYCKEBY, Sweden; Not yet recruiting

Research Site, MALM�, Sweden; Recruiting

Research Site, MOHEDA, Sweden; Recruiting

Research Site, MOTALA, Sweden; Recruiting

Research Site, �REBRO, Sweden; Recruiting

Research Site, �STERSUND, Sweden; Recruiting

Research Site, SKAN�R, Sweden; Recruiting

Research Site, S�DER�KRA, Sweden; Recruiting

Research Site, STENUNGSUND, Sweden; Recruiting

Research Site, STOCKSUND, Sweden; Recruiting

Research Site, TIMR�, Sweden; Recruiting

Research Site, UDDEVALLA, Sweden; Recruiting

Research Site, ULRICEHAMN, Sweden; Recruiting

Research Site, V�STER�S, Sweden; Recruiting

Research Site, V�STERVIK, Sweden; Recruiting

Research Site, V�XJ�, Sweden; Recruiting

Starting date: October 2006
Ending date: February 2009
Last updated: February 2, 2008