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

ABSTRACT: 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.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.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.Clinicaltrials.gov NCT01258829.

SUBMITTER: Whinnett ZI

PROVIDER: S-EPMC3992145 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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

Whinnett Zachary I ZI Sohaib S M Afzal SM Jones Siana S Kyriacou Andreas A March Katherine K Coady Emma E Mayet Jamil J Hughes Alun D AD Frenneaux Michael M Francis Darrel P DP

BMC cardiovascular disorders 20140403

<h4>Background</h4>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.<h4 ...[more]

PMID: 24693953

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Project description:ObjectivesBRAVO (British Randomized Controlled Trial of AV and VV Optimization) is a multicenter, randomized, crossover, noninferiority trial comparing echocardiographic optimization of atrioventricular (AV) and interventricular delay with a noninvasive blood pressure method.BackgroundCardiac resynchronization therapy including AV delay optimization confers clinical benefit, but the optimization requires time and expertise to perform.MethodsThis study randomized patients to echocardiographic optimization or hemodynamic optimization using multiple-replicate beat-by-beat noninvasive blood pressure at baseline; after 6 months, participants were crossed over to the other optimization arm of the trial. The primary outcome was exercise capacity, quantified as peak exercise oxygen uptake. Secondary outcome measures were echocardiographic left ventricular (LV) remodeling, quality-of-life scores, and N-terminal pro-B-type natriuretic peptide.ResultsA total of 401 patients were enrolled, the median age was 69 years, 78% of patients were men, and the New York Heart Association functional class was II in 84% and III in 16%. The primary endpoint, peak oxygen uptake, met the criterion for noninferiority (pnoninferiority = 0.0001), with no significant difference between the hemodynamically optimized arm and echocardiographically optimized arm of the trial (mean difference 0.1 ml/kg/min). Secondary endpoints for noninferiority were also met for symptoms (mean difference in Minnesota score 1; pnoninferiority = 0.002) and hormonal changes (mean change in N-terminal pro-B-type natriuretic peptide -10 pg/ml; pnoninferiority = 0.002). There was no significant difference in LV size (mean change in LV systolic dimension 1 mm; pnoninferiority < 0.001; LV diastolic dimension 0 mm; pnoninferiority <0.001). In 30% of patients the AV delay identified as optimal was more than 20 ms from the nominal setting of 120 ms.ConclusionsOptimization of cardiac resynchronization therapy devices by using noninvasive blood pressure is noninferior to echocardiographic optimization. Therefore, noninvasive hemodynamic optimization is an acceptable alternative that has the potential to be automated and thus more easily implemented. (British Randomized Controlled Trial of AV and VV Optimization [BRAVO]; NCT01258829).

Project description:IntroductionGlobally, diabetic retinopathy (DR) is a major cause of blindness. Sub-Saharan Africa is projected to see the largest proportionate increase in the number of people living with diabetes over the next two decades. Screening for DR is recommended to prevent sight loss; however, in many low and middle-income countries, because of a lack of specialist eye care staff, current screening services for DR are not optimal. The use of artificial intelligence (AI) for DR screening, which automates the grading of retinal photographs and provides a point-of-screening result, offers an innovative potential solution to improve DR screening in Tanzania.Methods and analysisWe will test the hypothesis that AI-supported DR screening increases the proportion of persons with true referable DR who attend the central ophthalmology clinic following referral after screening in a single-masked, parallel group, individually randomised controlled trial. Participants (2364) will be randomised (1:1 ratio) to either AI-supported or the standard of care DR screening pathway. Participants allocated to the AI-supported screening pathway will receive their result followed by point-of-screening counselling immediately after retinal image capture. Participants in the standard of care arm will receive their result and counselling by phone once the retinal images have been graded in the usual way (typically after 2-4 weeks). The primary outcome is the proportion of persons with true referable DR attending the central ophthalmology clinic within 8 weeks of screening. Secondary outcomes, by trial arm, include the proportion of persons attending the central ophthalmology clinic out of all those referred, sensitivity and specificity, number of false positive referrals, acceptability and fidelity of AI-supported screening.Ethics and disseminationThe London School of Hygiene & Tropical Medicine, Kilimanjaro Christian Medical Centre and Tanzanian National Institute of Medical Research ethics committees have approved the trial. The results will be submitted to peer-reviewed journals for publication.Trial registration numberISRCTN18317152.

Project description:IntroductionIn non-elderly adults, aortic valve replacement (AVR) with conventional prostheses yield poor long-term outcomes. Recent publications suggest a benefit of the Ross procedure over conventional AVR and highlight the need for high-quality randomised controlled trial (RCTs) on the optimal AVR. We have initiated a pilot trial assess two feasibility criteria and one assumption: (1) evaluate the capacity to enrol six patients per centre per year in at least five international centre, (2) validate greater than 90% compliance with allocation and (3) to validate the proportion of mechanical (≥65%) vs biological (≤35%) valves in the conventional arm.Methods and analysisRoss for Valve replacement In AduLts (REVIVAL) is a multinational, expertise-based RCT in adults aged 18-60 years undergoing AVR, comparing the Ross procedure versus one of the alternative approaches (mechanical vs stented or stentless bioprosthesis). The feasibility objectives will be assessed after randomising 60 patients; we will then make a decision regarding whether to expand the trial with the current protocol. We will ultimately examine the impact of the Ross procedure as compared with conventional AVR in non-elderly adults on survival free of valve-related life-threatening complications (major bleeding, systemic thromboembolism, valve thrombosis and valve reoperation) over the duration of follow-up. The objectives of the pilot trial will be analysed using descriptive statistics. In the full trial, the intention-to-treat principle will guide all primary analyses. A time-to-event analysis will be performed and Kaplan-Meier survival curves with comparison between groups using a log rank test will be presented.Ethics and disseminationREVIVAL will answer whether non-elderly adults benefit from the Ross procedure over conventional valve replacement. The final results at major meetings, journals, regional seminars, hospital rounds and via the Reducing Global Perioperative Risk Multimedia Resource Centre.Trial registration numberClinicalTrials.gov Identifier: NCT03798782 PROTOCOL VERSION: January 29, 2019 (Final Version 1.0).

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

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

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