NCT02382484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

February 18, 2015

Last Update Submit

March 5, 2015

Conditions

Hypertension

Keywords

Hypertension Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (1)

Treatment

EXPERIMENTAL

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)

Interventions

A dual chamber pacing system (BackBeat Medical)DEVICE

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.

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, China

Location

MeSH Terms

Conditions

HypertensionHypertension Resistant to Conventional Therapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Bing Yang, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2015

First Posted

March 6, 2015

Study Start

March 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

CN(1)