British Randomised Controlled Trial of Atrioventricular (AV) and Interventricular (VV) Optimisation (BRAVO)

Conditions

Heart Failure

Keywords

Heart Failure Cardiac Resynchronisation Therapy

Brief summary

Many patients who have cardiac resynchronisation therapy (a type of pacemaker) implanted for heart failure do not have the settings of their device optimised. The most widely available method for optimisation uses flow measured using cardiac ultrasound (echocardiography) to determine the optimal settings. However, this is not frequently performed because it is time consuming and requires two skilled operators. In this study the investigators will test a new non-invasive method for optimisation, which utilises pressure measurements (non-invasive blood pressure measured from the finger). Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation.

Whinnett ZI, Sohaib SMA, Mason M, Duncan E, Tanner M, Lefroy D, Al-Obaidi M, Ellery S, Leyva-Leon F, Betts T, Dayer M, Foley P, Swinburn J, Thomas M, Khiani R, Wong T, Yousef Z, Rogers D, Kalra PR, Dhileepan V, March K, Howard J, Kyriacou A, Mayet J, Kanagaratnam P, Frenneaux M, Hughes AD, Francis DP.

2018-05-1622 citations

10.1016/j.jcmg.2018.02.014

Cardiac resynchronization therapy: mechanisms of action and scope for further improvement in cardiac function

Siana Jones, Joost Lumens, S.M. Afzal Sohaib, Judith A. Finegold, Prapa Kanagaratnam et al. (14 authors)

EP Europace2016-07-1360 citations

10.1093/europace/euw136

British randomised controlled trial of AV and VV optimization ("BRAVO") study: rationale, design, and endpoints.

Whinnett ZI, Sohaib SM, Jones S, Kyriacou A, March K, Coady E, Mayet J, Hughes AD, Frenneaux M, Francis DP, BRAVO Investigators.

2014-04-035 citations

10.1186/1471-2261-14-42

Interventions

OTHERNon-invasive haemodynamic optimisation

Comparing the method of non-invasive haemodynamic

OTHERECHO optimisation

Standard ECHO optimisation method

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Chronic heart failure due to systolic dysfunction * Biventricular pacemaker implanted * Give written informed consent

Exclusion criteria

* Lung disease or any condition that would preclude them from walking on a treadmill

Design outcomes

Primary

Measure	Time frame
Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation	6 months following the last follow-up of the last patient

Secondary

Measure	Time frame
To determine whether pressure optimisation is at least equivalent to echo optimisation of flow: in terms resulting size of the heart in terms of quality of life scores in terms of blood marker of heart failure severity	6 months following the last follow-up of the last patient

Countries

United Kingdom

Outcome results

None listed