BACKBEAT Trial
Research type
Research Study
Full title
BradycArdia paCemaKer with AV interval modulation for Blood prEssure treAtmenT (BACKBEAT Trial)
IRAS ID
337061
Contact name
Christopher Aldo Rinaldi
Contact email
Sponsor organisation
Orchestra BioMed
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 28 days
Research summary
This is a multi-national, randomized, double-blinded study to evaluate the safety and effectiveness of AVIM therapy in patients with uncontrolled hypertension with a previously implanted Medtronic Astra/Azure pacemaker. Over 500 participants will be recruited across 100 sites in UK, Europe and US. AVIM is an investigational therapy that can be added to a pacemaker to allow for specific settings that may help with the treatment of hypertension. The study will be performed in three phases, Screening/Run-In, Randomised double-blind and Randomised unblinded. Patients within 90 days of a pacemaker implant will be approached to participate in the study. Participants who have provided written informed consent and meet the eligibility criteria will be observed and tested for 4 weeks to ensure they are in a stable condition and to provide baseline observations known as Run-In phase. At the end of the Run-In phase, participants will be assessed for eligibility for randomisation (Randomisation phase). Participants who meet the criteria for randomisation will have the AVIM therapy downloaded to their implanted pacemaker. AVIM therapy will be activated, and settings varied until optimal settings are identified to reduce blood pressure. If the optimal settings are identified, the pacemaker will be programmed to the randomisation group the participant is assigned to. Participants will have a 50/50 chance of getting the AVIM therapy (Treatment group) or not (Control group). The participants and research study team will be blinded to the group the participant is randomised to, except for two unblinded site personnel. Participants will be followed up to 12 months during the Randomised double-blind phase. At the end of the blinded phase, all participants will be unblinded and given the option to remain in their assigned randomised group or cross over. Participants will be followed up yearly up to 36 months during the Randomised unblinded phase.
REC name
London - Stanmore Research Ethics Committee
REC reference
24/LO/0115
Date of REC Opinion
1 Mar 2024
REC opinion
Further Information Favourable Opinion