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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: A dual chamber pacing system (BackBeat Medical)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • The Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: BackBeat Medical Inc
• Investigators: Principal Investigator: Bing Yang, MD, The Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: March 5, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Hypertension Resistant to Conventional Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: Acute FIM Study - China