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

Zachary I Whinnett, S M Afzal Sohaib, Siana Jones, Andreas Kyriacou, Katherine March, Emma Coady, Jamil Mayet, Alun D Hughes, Michael Frenneaux, Darrel P Francis, BRAVO Investigators

Research output: Contribution to journalArticle

3 Citations (Scopus)
3 Downloads (Pure)

Abstract

BACKGROUND: Echocardiographic optimization of pacemaker settings is the current standard of care for patients treated with cardiac resynchronization therapy. However, the process requires considerable time of expert staff. The BRAVO study is a non-inferiority trial comparing echocardiographic optimization of atrioventricular (AV) and interventricular (VV) delay with an alternative method using non-invasive blood pressure monitoring that can be automated to consume less staff resources.

METHODS/DESIGN: BRAVO is a multi-centre, randomized, cross-over, non-inferiority trial of 400 patients with a previously implanted cardiac resynchronization device. Patients are randomly allocated to six months in each arm. In the echocardiographic arm, AV delay is optimized using the iterative method and VV delay by maximizing LVOT VTI. In the haemodynamic arm AV and VV delay are optimized using non-invasive blood pressure measured using finger photoplethysmography. At the end of each six month arm, patients undergo the primary outcome measure of objective exercise capacity, quantified as peak oxygen uptake (VO2) on a cardiopulmonary exercise test. Secondary outcome measures are echocardiographic measurement of left ventricular remodelling, quality of life score and N-terminal pro B-type Natriuretic Peptide (NT-pro BNP). The study is scheduled to complete recruitment in December 2013 and to complete follow up in December 2014.

DISCUSSION: If exercise capacity is non-inferior with haemodynamic optimization compared with echocardiographic optimization, it would be proof of concept that haemodynamic optimization is an acceptable alternative which has the potential to be more easily implemented.

TRIAL REGISTRATION: Clinicaltrials.gov NCT01258829.

Original languageEnglish
Article number42
JournalBMC Cardiovascular Disorders
Volume14
DOIs
Publication statusPublished - 3 Apr 2014

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Arm
Randomized Controlled Trials
Cardiac Resynchronization Therapy
Hemodynamics
Outcome Assessment (Health Care)
Photoplethysmography
Exercise
Blood Pressure
Ventricular Remodeling
Brain Natriuretic Peptide
Standard of Care
Exercise Test
Fingers
Quality of Life
Oxygen
Equipment and Supplies

Keywords

  • Biological Markers
  • Blood Pressure Determination
  • Cardiac Resynchronization Therapy
  • Cardiac Resynchronization Therapy Devices
  • Clinical Protocols
  • Cross-Over Studies
  • Echocardiography, Doppler
  • Exercise Test
  • Exercise Tolerance
  • Great Britain
  • Heart Failure
  • Hemodynamics
  • Humans
  • Natriuretic Peptide, Brain
  • Peptide Fragments
  • Photoplethysmography
  • Predictive Value of Tests
  • Quality of Life
  • Questionnaires
  • Recovery of Function
  • Research Design
  • Time Factors
  • Treatment Outcome
  • Ventricular Function, Left
  • Ventricular Remodeling
  • Optimization

Cite this

Whinnett, Z. I., Sohaib, S. M. A., Jones, S., Kyriacou, A., March, K., Coady, E., ... BRAVO Investigators (2014). British randomised controlled trial of AV and VV optimization ("BRAVO") study: rationale, design, and endpoints. BMC Cardiovascular Disorders, 14, [42]. https://doi.org/10.1186/1471-2261-14-42

British randomised controlled trial of AV and VV optimization ("BRAVO") study : rationale, design, and endpoints. / Whinnett, Zachary I; Sohaib, S M Afzal; Jones, Siana; Kyriacou, Andreas; March, Katherine; Coady, Emma; Mayet, Jamil; Hughes, Alun D; Frenneaux, Michael; Francis, Darrel P; BRAVO Investigators.

In: BMC Cardiovascular Disorders, Vol. 14, 42, 03.04.2014.

Research output: Contribution to journalArticle

Whinnett, ZI, Sohaib, SMA, Jones, S, Kyriacou, A, March, K, Coady, E, Mayet, J, Hughes, AD, Frenneaux, M, Francis, DP & BRAVO Investigators 2014, 'British randomised controlled trial of AV and VV optimization ("BRAVO") study: rationale, design, and endpoints' BMC Cardiovascular Disorders, vol. 14, 42. https://doi.org/10.1186/1471-2261-14-42
Whinnett, Zachary I ; Sohaib, S M Afzal ; Jones, Siana ; Kyriacou, Andreas ; March, Katherine ; Coady, Emma ; Mayet, Jamil ; Hughes, Alun D ; Frenneaux, Michael ; Francis, Darrel P ; BRAVO Investigators. / British randomised controlled trial of AV and VV optimization ("BRAVO") study : rationale, design, and endpoints. In: BMC Cardiovascular Disorders. 2014 ; Vol. 14.
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T2 - rationale, design, and endpoints

AU - Whinnett, Zachary I

AU - Sohaib, S M Afzal

AU - Jones, Siana

AU - Kyriacou, Andreas

AU - March, Katherine

AU - Coady, Emma

AU - Mayet, Jamil

AU - Hughes, Alun D

AU - Frenneaux, Michael

AU - Francis, Darrel P

AU - BRAVO Investigators

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N2 - BACKGROUND: Echocardiographic optimization of pacemaker settings is the current standard of care for patients treated with cardiac resynchronization therapy. However, the process requires considerable time of expert staff. The BRAVO study is a non-inferiority trial comparing echocardiographic optimization of atrioventricular (AV) and interventricular (VV) delay with an alternative method using non-invasive blood pressure monitoring that can be automated to consume less staff resources.METHODS/DESIGN: BRAVO is a multi-centre, randomized, cross-over, non-inferiority trial of 400 patients with a previously implanted cardiac resynchronization device. Patients are randomly allocated to six months in each arm. In the echocardiographic arm, AV delay is optimized using the iterative method and VV delay by maximizing LVOT VTI. In the haemodynamic arm AV and VV delay are optimized using non-invasive blood pressure measured using finger photoplethysmography. At the end of each six month arm, patients undergo the primary outcome measure of objective exercise capacity, quantified as peak oxygen uptake (VO2) on a cardiopulmonary exercise test. Secondary outcome measures are echocardiographic measurement of left ventricular remodelling, quality of life score and N-terminal pro B-type Natriuretic Peptide (NT-pro BNP). The study is scheduled to complete recruitment in December 2013 and to complete follow up in December 2014.DISCUSSION: If exercise capacity is non-inferior with haemodynamic optimization compared with echocardiographic optimization, it would be proof of concept that haemodynamic optimization is an acceptable alternative which has the potential to be more easily implemented.TRIAL REGISTRATION: Clinicaltrials.gov NCT01258829.

AB - BACKGROUND: Echocardiographic optimization of pacemaker settings is the current standard of care for patients treated with cardiac resynchronization therapy. However, the process requires considerable time of expert staff. The BRAVO study is a non-inferiority trial comparing echocardiographic optimization of atrioventricular (AV) and interventricular (VV) delay with an alternative method using non-invasive blood pressure monitoring that can be automated to consume less staff resources.METHODS/DESIGN: BRAVO is a multi-centre, randomized, cross-over, non-inferiority trial of 400 patients with a previously implanted cardiac resynchronization device. Patients are randomly allocated to six months in each arm. In the echocardiographic arm, AV delay is optimized using the iterative method and VV delay by maximizing LVOT VTI. In the haemodynamic arm AV and VV delay are optimized using non-invasive blood pressure measured using finger photoplethysmography. At the end of each six month arm, patients undergo the primary outcome measure of objective exercise capacity, quantified as peak oxygen uptake (VO2) on a cardiopulmonary exercise test. Secondary outcome measures are echocardiographic measurement of left ventricular remodelling, quality of life score and N-terminal pro B-type Natriuretic Peptide (NT-pro BNP). The study is scheduled to complete recruitment in December 2013 and to complete follow up in December 2014.DISCUSSION: If exercise capacity is non-inferior with haemodynamic optimization compared with echocardiographic optimization, it would be proof of concept that haemodynamic optimization is an acceptable alternative which has the potential to be more easily implemented.TRIAL REGISTRATION: Clinicaltrials.gov NCT01258829.

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KW - Exercise Tolerance

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KW - Heart Failure

KW - Hemodynamics

KW - Humans

KW - Natriuretic Peptide, Brain

KW - Peptide Fragments

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KW - Predictive Value of Tests

KW - Quality of Life

KW - Questionnaires

KW - Recovery of Function

KW - Research Design

KW - Time Factors

KW - Treatment Outcome

KW - Ventricular Function, Left

KW - Ventricular Remodeling

KW - Optimization

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DO - 10.1186/1471-2261-14-42

M3 - Article

VL - 14

JO - BMC Cardiovascular Disorders

JF - BMC Cardiovascular Disorders

SN - 1471-2261

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