Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391846
• Other study ID #: D2452L00010
• Secondary ID: EUDRACT No. 2006
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2006
• Last updated: June 18, 2012
• Start date: October 2006
• Est. completion date: January 2009

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Signs and Symptoms
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Drug:
• Captopril

• Enalapril

• Lisinopril

• Ramipril

• Trandolapril

• Bisoprolol

• Carvedilol

• Metoprolol succinate

• Candesartan

• Valsartan

• Eplerenone

• Spironolactone

• Diuretics

• HF treatment according to Swedish guidelines

Procedure:
• Blood samples

• The Kansas City Cardiomyopathy Questionnaire (KCCQ)

Locations

Country	Name	City	State
Sweden	Research Site	Alvesta
Sweden	Research Site	Arvika
Sweden	Research Site	Bjuv
Sweden	Research Site	Borensberg
Sweden	Research Site	Bromma
Sweden	Research Site	Dalby
Sweden	Research Site	Eskilstuna
Sweden	Research Site	Gagnef
Sweden	Research Site	Goeteborg
Sweden	Research Site	Hisings Karra
Sweden	Research Site	Huddinge
Sweden	Research Site	Huskvarna
Sweden	Research Site	Joenkoeping
Sweden	Research Site	Kalmar
Sweden	Research Site	Kungalv
Sweden	Research Site	Lerum
Sweden	Research Site	Lessebo
Sweden	Research Site	Lidkoping
Sweden	Research Site	Lilla Edet
Sweden	Research Site	Linkoeping
Sweden	Research Site	Ludvika
Sweden	Research Site	Lyckeby
Sweden	Research Site	Malmo
Sweden	Research Site	Moheda
Sweden	Research Site	Motala
Sweden	Research Site	Orebro
Sweden	Research Site	Ostersund
Sweden	Research Site	Skanor
Sweden	Research Site	Soderakra
Sweden	Research Site	Stenungsund
Sweden	Research Site	Stocksund
Sweden	Research Site	Timra
Sweden	Research Site	Uddevalla
Sweden	Research Site	Ulricehamn
Sweden	Research Site	Umea
Sweden	Research Site	Uppsala
Sweden	Research Site	Vasteras
Sweden	Research Site	Vastervik
Sweden	Research Site	Vaxjo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	The non-parametric scale is constructed from 3 variables, modified after Cleland. Each patient receives a rank score from 1 to 246 (246-number of patients in the study). The lowest score receive patients who die (due to CV event), next patients still alive at end-of-study with the worst composite score, the best alive patients with 0 days in hospital and the largest improvement in the KCCQ (self-administered by patient symptom score, where the higher score reflect better health status). Scores will be summarized using non-parametric calculations. The mean of non-parametric scores is presented	9 months	No
Secondary	Number of CV Deaths	Number of deaths	9 months	No
Secondary	Number of Days in Hospital for CV Reason	Each overnight stay is counted as one day. The lower the better	9 months	No
Secondary	Changes in Heart Failure Symptoms	Changes from baseline in the symptom score subset (question 3, 5, 7 and 9) of KCCQ (swelling, fatigue, shortness of breath, shortness of breath night time). KCCQ is a self-administered by patient symptom score, where higher score reflect better health status. Scale scores are transformed to a 0 to 100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. This mean that the KCCQ scale is from 0 to 100 with the higher value showing a better health status.	9 months and baseline	No
Secondary	Changes in NT-proBNP Values Over Time in All Patients	The 95% confidential interval (CI) is given as measure of dispersion	9 months and baseline	No
Secondary	Changes in Health-related Quality of Life	Change range -100 to 100. The higher the better.	9 months and baseline	No
Secondary	Total Number of Titration Steps in Prescribed Heart Failure Treatment	Each titration step in prescribed medication is counted as one step, either up or down. One step up indicates an increase of dose in prescribed medication and one step down indicates a decrease of dose in prescribed medication. The sum of steps is given as a score. Score is given for each arm as a total number of titration steps for all patients in arm.	9 months	No
Secondary	Discontinuations	Number of patients discontinued due to adverse events'	9 months	Yes