Hypertension
Conditions
Keywords
Hypertension Resistant to Conventional Therapy
Brief summary
The purpose of this study is to test whether the A-V sequential pacing strategy shown to effectively reduce blood pressure in a dog model of hypertension also reduces blood pressure acutely in patients with hypertension (systolic blood pressure greater than 140 mmHg) despite medical treatments.
Interventions
DEVICEA dual chamber pacing system (BackBeat Medical)
For each patient, one pacing electrode was placed in the right atrium and the second electrode was placed in the right ventricle. With a dual chamber pacing system (BackBeat Medical) it was possible to pace the heart with a wide variety of pacing settings.
Sponsors
BackBeat Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has hypertension with systolic blood pressure \>140 mmHg despite at least one antihypertensive medication. 2. Patient has a clinical indication for a pacemaker or an electrophysiology study involving introduction of transvenous electrophysiology catheters to the right atrium and/or right ventricle. 3. Patient is willing and able to provide informed consent
Exclusion criteria
1. Patient is in atrial fibrillation at the time of the study 2. Patient has an ejection fraction less than 45% 3. Patient has a history of symptomatic heart failure, regardless of EF 4. Patient is undergoing an ablation procedure for a bypass track (WPW) 5. Patient has a history of resuscitation from ventricular fibrillation or sustained ventricular tachycardia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of blood pressure upon initiation of pacing with AV delays of 2 ms | Approx. 5 minutes after initiating pacing with the respective AV delay |
| Change of blood pressure upon initiation of pacing with AV delays of 20 ms | Approx. 5 minutes after initiating pacing with the respective AV delay |
| Change of blood pressure upon initiation of pacing with AV delays of 40 ms | Approx. 5 minutes after initiating pacing with the respective AV delay |
| Change of blood pressure upon initiation of pacing with AV delays of 80 ms | Approx. 5 minutes after initiating pacing with the respective AV delay |
| Assessment of any adverse effects | Over a 24 hour period following the acute tests |
Countries
China
Outcome results
None listed