Impact of Pacing Site and AV Delay on Blood Pressure in Hypertensive Patients

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Pacing Site and AV Delay on Blood Pressure in Hypertensive Patients: An Acute Study in Patients Undergoing an Electrophysiology Study or Pacemaker Implant

Conditions
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Hypertension

Intervention / Treatment
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* Device: A dual chamber pacing system (BackBeat Medical)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has hypertension with systolic blood pressure >140 mmHg despite at least one antihypertensive medication. 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. Patient is willing and able to provide informed consent Exclusion Criteria: Patient is in atrial fibrillation at the time of the study Patient has an ejection fraction less than 45% Patient has a history of symptomatic heart failure, regardless of EF Patient is undergoing an ablation procedure for a bypass track (WPW) Patient has a history of resuscitation from ventricular fibrillation or sustained ventricular tachycardia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The study was a single arm, unblinded, treatment only study. Each patient served as his or her own control. Treatment delivered by a dual chamber pacing system (BackBeat Medical) which was able to generate stimulating patterns with characteristics that are different than the common pacemaker. The study was limited to hypertensive patients who were also already scheduled to undergo an invasive electrophysiology procedure. | Device: A dual chamber pacing system (BackBeat Medical)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension Resistant to Conventional Therapy