Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000383561
Ethics application status
Approved
Date submitted
10/08/2006
Date registered
30/08/2006
Date last updated
2/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
THE MAXIMISE STUDY
Scientific title
Effectiveness of a specialist nurse supervised titration clinic on titration of beta blocker therapy in patients with chronic heart failure (CHF)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic (systolic) heart failure 1349 0
Condition category
Condition code
Cardiovascular 1439 1439 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nurse Supervised Titration Clinic for beta blocker titration. Those randomised to the Nurse Supervised Titration Clinic will attend appointments as needed to achieve maximum tolerated dose of beta blocker as quickly as possible within a 6 month period. At each visit (taking approximately 1 hour) the nurse will assess the patient, determine appropriate medication changes and provide education. All changes to treatment will be approved by medical staff in the Heart Function Clinic. Recommendations for beta blocker up titration will be provided to the GP by HFC medical staff.
Intervention code [1] 1275 0
Other interventions
Comparator / control treatment
Usual Care (GP plus as needed specialist Heart Function Clinic (HFC) attendance) for beta blocker titration. Patients randomised to Usual Care will be seen in the HFC at baseline, 3 months and 6 months.
Control group
Active

Outcomes
Primary outcome [1] 1977 0
Time to maximum dose beta blockers
Timepoint [1] 1977 0
Documented at 6 months
Secondary outcome [1] 3444 0
Maximum dose beta blocker achieved
Timepoint [1] 3444 0
Documented at 6 months
Secondary outcome [2] 3445 0
Mean dose beta blocker at 6 months
Timepoint [2] 3445 0
Documented at 6 months

Eligibility
Key inclusion criteria
1. CHF with beta blocker therapy at less than half target dose requiring up-titration2. Left ventricular (LV) systolic dysfunction as documented by RNVG or echocardiography3. Written informed consent prior to enrolment.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previously failed an up-titration of beta blocker in the previous six months2. Medically inappropriate for up-titration of beta blockers in a nurse supervised heart filaure titration clinic.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated random numbers held in sealed envelopes by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Groups balanced after every six patients using the block method outlined by Peto et al (1976).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1577 0
Charities/Societies/Foundations
Name [1] 1577 0
Austin Hospital Medical Research Foundation: in-house research funds of A/Prof David L.
Country [1] 1577 0
Australia
Funding source category [2] 1578 0
Commercial sector/Industry
Name [2] 1578 0
Roche Products
Country [2] 1578 0
Australia
Primary sponsor type
Individual
Name
In-house (Austin Hospital Medical Research Foundation) research funds of A/Prof David L. Hare
Address
Studley Road
HEIDELBERG, 3084 VICTORIA
Country
Australia
Secondary sponsor category [1] 1385 0
Commercial sector/Industry
Name [1] 1385 0
Roche Products Pty Ltd
Address [1] 1385 0
81-89 Hotham Road
KEW, VICTORIA
Country [1] 1385 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3003 0
Austin Health
Ethics committee address [1] 3003 0
Ethics committee country [1] 3003 0
Australia
Date submitted for ethics approval [1] 3003 0
Approval date [1] 3003 0
06/01/2006
Ethics approval number [1] 3003 0
H2006/02397

Summary
Brief summary
Chronic heart failure (CHF) occurs when the heart is unable to supply enough blood to meet the needs of the body. Common symptoms of CHF include breathlessness, fatigue and swelling of the lower legs. Clinical trials have shown several drug treatments (in particular, beta blockers) to be beneficial in reducing hospital admissions, and improving length and quality of life. In all the major clinical trials beta blocker therapy has been started and gradually increased to a target dose (or the maximum tolerated dose) over the course of several weeks. International and national expert guidelines recommend that patients with CHF be prescribed a beta blocker, however the benefits of beta blocker therapy cannot be assumed to follow when the doses used in the clinical trials have not been reached. For this reason it is important to ensure that patients receive the highest tolerated dosage. Also, there are data from some trials that suggest that the benefits of beta-blockade are detectable within the first few weeks. Thus any delay in the commencement and increase to maximum dose should be minimized. The aim of this study is to determine whether patients attending a specialist Nurse Supervised Titration Clinic reach higher doses of beta blocker sooner than patients receiving Usual Care. Usual Care involves visits to the Heart Function Clinic doctor every 3 months with visits to the GP in between.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35180 0
Address 35180 0
Country 35180 0
Phone 35180 0
Fax 35180 0
Email 35180 0
Contact person for public queries
Name 10464 0
Deidre Toia
Address 10464 0
Research Coordinator
Department of Cardiology HSB Level 5
Austin Health
Studley Rd,
Heidelberg VIC 3084
Country 10464 0
Australia
Phone 10464 0
+61 3 94963652
Fax 10464 0
Email 10464 0
[email protected]
Contact person for scientific queries
Name 1392 0
A/Prof David L. Hare
Address 1392 0
Director of Research
Department of Cardiology HSB Level 5
Austin Health
Studley Rd,
Heidelberg VIC 3084
Country 1392 0
Australia
Phone 1392 0
+61 3 94963815
Fax 1392 0
Email 1392 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.