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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00391846

Recruitment Status : Completed

First Posted : October 25, 2006

Results First Posted : June 18, 2012

Last Update Posted : June 25, 2012

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Description

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

Condition or disease	Intervention/treatment	Phase
Heart Failure Ventricular Dysfunction, Left	Drug: 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 Procedure: Blood samples Procedure: The Kansas City Cardiomyopathy Questionnaire (KCCQ)	Phase 4

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	252 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
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 Start Date :	October 2006
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Guided by NT-proBNP Treatment guided by clinical symptoms and signs + NTproBNP	Drug: Captopril Drug: Enalapril Drug: Lisinopril Drug: Ramipril Drug: Trandolapril Drug: Bisoprolol Drug: Carvedilol Drug: Metoprolol succinate Drug: Candesartan Other Name: Atacand Drug: Valsartan Drug: Eplerenone Drug: Spironolactone Drug: Diuretics Drug: HF treatment according to Swedish guidelines Procedure: Blood samples Procedure: The Kansas City Cardiomyopathy Questionnaire (KCCQ)
Not Guided by NT-proBNP Treatment guided by clinical symptoms and signs	Drug: Captopril Drug: Enalapril Drug: Lisinopril Drug: Ramipril Drug: Trandolapril Drug: Bisoprolol Drug: Carvedilol Drug: Metoprolol succinate Drug: Candesartan Other Name: Atacand Drug: Valsartan Drug: Eplerenone Drug: Spironolactone Drug: Diuretics Drug: HF treatment according to Swedish guidelines Procedure: Blood samples Procedure: The Kansas City Cardiomyopathy Questionnaire (KCCQ)

Outcome Measures

Primary Outcome Measures :

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) [ Time Frame: 9 months ]
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

Secondary Outcome Measures :

Number of CV Deaths [ Time Frame: 9 months ]
Number of deaths
Number of Days in Hospital for CV Reason [ Time Frame: 9 months ]
Each overnight stay is counted as one day. The lower the better
Changes in Heart Failure Symptoms [ Time Frame: 9 months and baseline ]
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.
Changes in NT-proBNP Values Over Time in All Patients [ Time Frame: 9 months and baseline ]
The 95% confidential interval (CI) is given as measure of dispersion
Changes in Health-related Quality of Life [ Time Frame: 9 months and baseline ]
Change range -100 to 100. The higher the better.
Total Number of Titration Steps in Prescribed Heart Failure Treatment [ Time Frame: 9 months ]
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.
Discontinuations [ Time Frame: 9 months ]
Number of patients discontinued due to adverse events'

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391846

Locations

Layout table for location information

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, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Layout table for investigator information

Study Director:	AstraZeneca Sweden Medical Director, MD	AstraZeneca
Principal Investigator:	Hans Persson, MD, PhD	Danderyd Hospital, Sweden
Study Director:	Bjorn Eriksson, MD	AstraZeneca

More Information

Layout table for additonal information

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00391846
Other Study ID Numbers:	D2452L00010 EUDRACT No. 2006-001259-36 SIGNAL HF
First Posted:	October 25, 2006 Key Record Dates
Results First Posted:	June 18, 2012
Last Update Posted:	June 25, 2012
Last Verified:	June 2012

Keywords provided by AstraZeneca:


Heart Failure Ventricular Dysfunction NTproBNP

Additional relevant MeSH terms:

Layout table for MeSH terms

Heart Failure Ventricular Dysfunction Ventricular Dysfunction, Left Heart Diseases Cardiovascular Diseases Metoprolol Valsartan Carvedilol Candesartan Ramipril Enalapril Lisinopril Eplerenone Bisoprolol Captopril	Trandolapril Spironolactone Diuretics Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists

To Top