Clinical trial NCT00391846: Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone
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 Heart Failure (HF) and Left Ventricular Systolic Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Ventricular Dysfunction, Left
Keywords: Heart Failure
Ventricular Dysfunction
NTproBNP
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-25
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Female/male, over 18 years with previously verified HF with left ventricular systolic dysfunction.
* New York Heart Association(NYHA) class II-IV,
* NTproBNP males\>800 ng/L, females \>1000 ng/L

Exclusion Criteria:

* Planned CV hospitalisation, stroke or acute myocardial infarction (MI) last 3 months,
* Mitral/aortic stenosis,
* Patients already receiving optimal HF treatment,
* Severe reduction of kidney function

Primary outcomes:
measure: Composite Value of 3 Variables After 9 Months: Cardiovascular Death (Days Alive), Cardiovascular Hospitalization (Days Out of Hospital), Heart Failure Symptoms (Symptom Score Subset of the Kansas City Cardiomyopathy Questionnaire - Questions 3,5,7,9)
timeFrame: 9 months
Secondary outcomes:
measure: Number of CV Deaths
timeFrame: 9 months
measure: Number of Days in Hospital for CV Reason
timeFrame: 9 months
measure: Changes in Heart Failure Symptoms
timeFrame: 9 months and baseline
measure: Changes in NT-proBNP Values Over Time in All Patients
timeFrame: 9 months and baseline
measure: Changes in Health-related Quality of Life
timeFrame: 9 months and baseline
measure: Total Number of Titration Steps in Prescribed Heart Failure Treatment
timeFrame: 9 months
measure: Discontinuations
timeFrame: 9 months
Other outcomes:
Locations:
city: Alvesta
country: Sweden
facility: Research Site
city: Arvika
country: Sweden
facility: Research Site
city: Bjuv
country: Sweden
facility: Research Site
city: Borensberg
country: Sweden
facility: Research Site
city: Bromma
country: Sweden
facility: Research Site
city: Dalby
country: Sweden
facility: Research Site
city: Eskilstuna
country: Sweden
facility: Research Site
city: Gagnef
country: Sweden
facility: Research Site
city: Goeteborg
country: Sweden
facility: Research Site
city: Hisings Karra
country: Sweden
facility: Research Site
city: Huddinge
country: Sweden
facility: Research Site
city: Huskvarna
country: Sweden
facility: Research Site
city: Joenkoeping
country: Sweden
facility: Research Site
city: Kalmar
country: Sweden
facility: Research Site
city: Kungalv
country: Sweden
facility: Research Site
city: Lerum
country: Sweden
facility: Research Site
city: Lessebo
country: Sweden
facility: Research Site
city: Lidkoping
country: Sweden
facility: Research Site
city: Lilla Edet
country: Sweden
facility: Research Site
city: Linkoeping
country: Sweden
facility: Research Site
city: Ludvika
country: Sweden
facility: Research Site
city: Lyckeby
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Moheda
country: Sweden
facility: Research Site
city: Motala
country: Sweden
facility: Research Site
city: Orebro
country: Sweden
facility: Research Site
city: Ostersund
country: Sweden
facility: Research Site
city: Skanor
country: Sweden
facility: Research Site
city: Soderakra
country: Sweden
facility: Research Site
city: Stenungsund
country: Sweden
facility: Research Site
city: Stocksund
country: Sweden
facility: Research Site
city: Timra
country: Sweden
facility: Research Site
city: Uddevalla
country: Sweden
facility: Research Site
city: Ulricehamn
country: Sweden
facility: Research Site
city: Umea
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Vasteras
country: Sweden
facility: Research Site
city: Vastervik
country: Sweden
facility: Research Site
city: Vaxjo
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Sweden Medical Director, MD
role: STUDY_DIRECTOR
affiliation: Danderyd Hospital, Sweden
name: Hans Persson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Bjorn Eriksson, MD
role: STUDY_DIRECTOR
References: