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THE MAXIMISE STUDY

Effectiveness of a specialist nurse supervised titration clinic on titration of beta blocker therapy in patients with chronic heart failure (CHF)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000383561
Enrollment
100
Registered
2006-08-30
Start date
2006-03-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

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.

Sponsors

In-house (Austin Hospital Medical Research Foundation) research funds of A/Prof David L. Hare
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026