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

NCT01258829 | Completed DMC

• 1 other identifier: 10/H0803/86
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure Cardiac Resynchronisation Therapy

Outcome Measures

Primary Outcomes (1)

• 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 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

  6 months following the last follow-up of the last patient

Study Arms (2)

Non-invasive haemodynamic optimisation

EXPERIMENTAL

Optimization of pressure production by the heart, as measured by systolic blood pressure in the systemic circulation

Other: Non-invasive haemodynamic optimisation

ECHO optimisation

ACTIVE COMPARATOR

Optimization of AV/VV delay using the guideline recommendations

Other: ECHO optimisation

Interventions

Non-invasive haemodynamic optimisation OTHER

Comparing the method of non-invasive haemodynamic

Non-invasive haemodynamic optimisation

ECHO optimisation OTHER

Standard ECHO optimisation method

ECHO optimisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead
• University of Aberdeen: collaborator

Study Sites (1)

ICCH, Imperial College London

London, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 29778861 DERIVED

• Jones 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.

  PMID: 27411361 DERIVED

• Whinnett 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.

  PMID: 24693953 DERIVED

• Jones 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.

  PMID: 24068445 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dr Darrel Francis

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 13, 2010
• Study Start: December 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 30, 2015

Record last verified: 2014-05

Locations

GB (1)