DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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); The Kansas City Cardiomyopathy Questionnaire (KCCQ) (Procedure)

Phase: Phase 4

Status: Completed

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

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

Clinical Details

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

Primary outcome: 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)

Secondary outcome:

Number of CV Deaths

Number of Days in Hospital for CV Reason

Changes in Heart Failure Symptoms

Changes in NT-proBNP Values Over Time in All Patients

Changes in Health-related Quality of Life

Total Number of Titration Steps in Prescribed Heart Failure Treatment

Discontinuations

Eligibility

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.

- 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

Locations and Contacts

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

Additional Information

Starting date: October 2006
Last updated: June 18, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017