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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: A dual chamber pacing system (BackBeat Medical)

• Registration Number: NCT02382484
• Lead Sponsor: BackBeat Medical Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2015-02-18
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-05
• Last Update Submitted: 2015-03-05
• Study First Posted: 2015-03-06
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	A dual chamber pacing system (BackBeat Medical)	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.

Primary Outcome Measures

Name	Time	Method
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 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
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 2 ms	Approx. 5 minutes after initiating pacing with the respective AV delay

Trial Locations

Locations (1)

The Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, China