British Randomised Controlled Trial of AV and VV Optimisation (BRAVO)
This study is currently recruiting participants.
Verified September 2012 by Imperial College London
Sponsor:
Imperial College London
Collaborator:
University of Aberdeen
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01258829
First received: December 10, 2010
Last updated: September 12, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure |
Other: Non-invasive haemodynamic optimisation Other: ECHO optimisation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Imperial College London:
Primary Outcome Measures:
- Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation [ Time Frame: 6 months following the last follow-up of the last patient ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Time Frame: 6 months following the last follow-up of the last patient ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Non-invasive haemodynamic optimisation
Optimization of pressure production by the heart, as measured by systolic blood pressure in the systemic circulation
|
Other: Non-invasive haemodynamic optimisation
Comparing the method of non-invasive haemodynamic
|
|
Active Comparator: ECHO optimisation
Optimization of AV/VV delay using the guideline recommendations
|
Other: ECHO optimisation
Standard ECHO optimisation method
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258829
Contacts
| Contact: Dr Darrel Francis | +44 (0) 20 7594 1093 | d.francis@imperial.ac.uk |
| Contact: Tina Chan | +44 (0) 20 7594 3443 | t.chan@imperial.ac.uk |
Locations
| United Kingdom | |
| ICCH, Imperial College London | Recruiting |
| London, United Kingdom | |
| Contact: Dr Darrel Francis +44 (0) 20 7594 1093 d.francis@imeprial.ac.uk | |
| Contact: Tina Chan +44 (0) 207 594 3443 t.chan@imeprial.ac.uk | |
Sponsors and Collaborators
Imperial College London
University of Aberdeen
Investigators
| Principal Investigator: | Dr Darrel Francis | Imperial College London |
More Information
No publications provided
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01258829 History of Changes |
| Other Study ID Numbers: | 10/H0803/86 |
| Study First Received: | December 10, 2010 |
| Last Updated: | September 12, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Imperial College London:
|
Heart Failure Cardiac Resynchronisation Therapy |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 13, 2013