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

Study Overview
=================
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.

Official Title
-----------------
British Randomised Controlled Trial of AV and VV Optimisation (BRAVO): Randomised Clinical Trial of the Effects of Non-invasive Haemodynamic Optimisation of Cardiac Resynchronisation Devices on Exercise Capacity

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Non-invasive haemodynamic optimisation
* Other: ECHO optimisation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-invasive haemodynamic optimisation<br>Optimization of pressure production by the heart, as measured by systolic blood pressure in the systemic circulation | Other: Non-invasive haemodynamic optimisation<br>* Comparing the method of non-invasive haemodynamic<br>|
| Active Comparator: ECHO optimisation<br>Optimization of AV/VV delay using the guideline recommendations | Other: ECHO optimisation<br>* Standard ECHO optimisation method<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure Cardiac Resynchronisation Therapy