Heart FailureBRAVONCT01258829
British Randomised Controlled Trial of Atrioventricular (AV) and Interventricular (VV) Optimisation (BRAVO)
A study testing Non-invasive haemodynamic optimisation and ECHO optimisation in people with Heart Failure, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Non-invasive haemodynamic optimisation and ECHO optimisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2010to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure due to systolic dysfunction
- Biventricular pacemaker implanted
- Give written informed consent
Who cannot join
- Lung disease or any condition that would preclude them from walking on a treadmill
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Heart Failure
- Being tested
- Non-invasive haemodynamic optimisation, ECHO optimisation
- Keywords
- Heart Failure Cardiac Resynchronisation Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive haemodynamic optimisationOther
Comparing the method of non-invasive haemodynamic
ECHO optimisationOther
Standard ECHO optimisation method
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive haemodynamic optimisation | Experimental | Optimization of pressure production by the heart, as measured by systolic blood pressure in the systemic circulation Receives: Other: Non-invasive haemodynamic optimisation |
| ECHO optimisation | Active comparator | Optimization of AV/VV delay using the guideline recommendations Receives: Other: ECHO optimisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is optimising AV and VV delay using non-invasive haemodynamics at least equivalent, in terms of exercise capacity, to conventional echo optimisation
Measured: 6 months following the last follow-up of the last patient
Secondary outcomes (1)
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
Measured: 6 months following the last follow-up of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aberdeen
- Responsible party
- Sponsor
- Investigators
- Dr Darrel Francis, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258829
- Sponsor's protocol ID
- 10/H0803/86
- Acronym
- BRAVO
- Status last verified
- May 2014
- First submitted
- 10 Dec 2010
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. Multicenter Randomized Controlled Crossover Trial Comparing Hemodynamic Optimization Against Echocardiographic Optimization of AV and VV Delay of Cardiac Resynchronization Therapy: The BRAVO Trial. JACC Cardiovasc Imaging. 2019 Aug;12(8 Pt 1):1407-1416. doi: 10.1016/j.jcmg.2018.02.014. Epub 2018 May 16.
PubMed 29778861Jones S, Lumens J, Sohaib SMA, Finegold JA, Kanagaratnam P, Tanner M, Duncan E, Moore P, Leyva F, Frenneaux M, Mason M, Hughes AD, Francis DP, Whinnett ZI; BRAVO Investigators. Cardiac resynchronization therapy: mechanisms of action and scope for further improvement in cardiac function. Europace. 2017 Jul 1;19(7):1178-1186. doi: 10.1093/europace/euw136.
PubMed 27411361Whinnett ZI, Sohaib SM, Jones S, Kyriacou A, March K, Coady E, Mayet J, Hughes AD, Frenneaux M, Francis DP; BRAVO Investigators. British randomised controlled trial of AV and VV optimization ("BRAVO") study: rationale, design, and endpoints. BMC Cardiovasc Disord. 2014 Apr 3;14:42. doi: 10.1186/1471-2261-14-42.
PubMed 24693953Jones S, Shun-Shin MJ, Cole GD, Sau A, March K, Williams S, Kyriacou A, Hughes AD, Mayet J, Frenneaux M, Manisty CH, Whinnett ZI, Francis DP. Applicability of the iterative technique for cardiac resynchronization therapy optimization: full-disclosure, 50-sequential-patient dataset of transmitral Doppler traces, with implications for future research design and guidelines. Europace. 2014 Apr;16(4):541-50. doi: 10.1093/europace/eut257. Epub 2013 Sep 25.
PubMed 24068445
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01258829
- Acronym / sponsor ID
- BRAVO / 10/H0803/86
- Conditions
- Heart Failure
- Keywords
- Heart Failure Cardiac Resynchronisation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Aberdeen
- Study start
- Dec 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive haemodynamic optimisation | Experimental | Other: Non-invasive haemodynamic optimisationOptimization of pressure production by the heart, as measured by systolic blood pressure in the systemic circulation |
| ECHO optimisation | Active comparator | Other: ECHO optimisationOptimization of AV/VV delay using the guideline recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic heart failure due to systolic dysfunction
- Biventricular pacemaker implanted
- Give written informed consent
Key exclusion criteria (1 listed)
- Lung disease or any condition that would preclude them from walking on a treadmill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive haemodynamic optimisationComparing the method of non-invasive haemodynamic | Other | Non-invasive haemodynamic optimisation |
| ECHO optimisationStandard ECHO optimisation method | Other | ECHO optimisation |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
- Derived from this study: PubMed 29778861Whinnett 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. Multicenter Randomized Controlled Crossover Trial Comparing Hemodynamic Optimization Against Echocardiographic Optimization of AV and VV Delay of Cardiac Resynchronization Therapy: The BRAVO Trial. JACC Cardiovasc Imaging. 2019 Aug;12(8 Pt 1):1407-1416. doi: 10.1016/j.jcmg.2018.02.014. Epub 2018 May 16.
- Derived from this study: PubMed 27411361Jones S, Lumens J, Sohaib SMA, Finegold JA, Kanagaratnam P, Tanner M, Duncan E, Moore P, Leyva F, Frenneaux M, Mason M, Hughes AD, Francis DP, Whinnett ZI; BRAVO Investigators. Cardiac resynchronization therapy: mechanisms of action and scope for further improvement in cardiac function. Europace. 2017 Jul 1;19(7):1178-1186. doi: 10.1093/europace/euw136.
- Derived from this study: PubMed 24693953Whinnett ZI, Sohaib SM, Jones S, Kyriacou A, March K, Coady E, Mayet J, Hughes AD, Frenneaux M, Francis DP; BRAVO Investigators. British randomised controlled trial of AV and VV optimization ("BRAVO") study: rationale, design, and endpoints. BMC Cardiovasc Disord. 2014 Apr 3;14:42. doi: 10.1186/1471-2261-14-42.
- Derived from this study: PubMed 24068445Jones S, Shun-Shin MJ, Cole GD, Sau A, March K, Williams S, Kyriacou A, Hughes AD, Mayet J, Frenneaux M, Manisty CH, Whinnett ZI, Francis DP. Applicability of the iterative technique for cardiac resynchronization therapy optimization: full-disclosure, 50-sequential-patient dataset of transmitral Doppler traces, with implications for future research design and guidelines. Europace. 2014 Apr;16(4):541-50. doi: 10.1093/europace/eut257. Epub 2013 Sep 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Darrel Francis principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive haemodynamic optimisation and ECHO optimisation in people with Heart Failure, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01258829, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.