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Completed

NCT Number: NCT02382484

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Hypertension Resistant to Conventional Therapy Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nanjing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change of blood pressure upon initiation of pacing with AV delays of 2 ms

    Time frame: Approx. 5 minutes after initiating pacing with the respective AV delay

  2. Change of blood pressure upon initiation of pacing with AV delays of 20 ms

    Time frame: Approx. 5 minutes after initiating pacing with the respective AV delay

  3. Change of blood pressure upon initiation of pacing with AV delays of 40 ms

    Time frame: Approx. 5 minutes after initiating pacing with the respective AV delay

  4. Change of blood pressure upon initiation of pacing with AV delays of 80 ms

    Time frame: Approx. 5 minutes after initiating pacing with the respective AV delay

  5. Assessment of any adverse effects

    Time frame: Over a 24 hour period following the acute tests

Sponsors and collaborators

Lead sponsor

BackBeat Medical Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 6, 2015
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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