HypertensionNCT02382484
Impact of Pacing Site and AV Delay on Blood Pressure in Hypertensive Patients
A study testing A dual chamber pacing system (BackBeat Medical) in people with Hypertension, run by BackBeat Medical Inc at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- A dual chamber pacing system (BackBeat Medical)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University
Nanjing
About this study
Official 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
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.
- Conditions
- Hypertension
- Being tested
- A dual chamber pacing system (BackBeat Medical)
- Keywords
- Hypertension Resistant to Conventional Therapy
- Medical subject headings
- Hypertension, Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: A dual chamber pacing system (BackBeat Medical) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of blood pressure upon initiation of pacing with AV delays of 2 ms
Measured: 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
Measured: 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
Measured: 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
Measured: Approx. 5 minutes after initiating pacing with the respective AV delay
Assessment of any adverse effects
Measured: Over a 24 hour period following the acute tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- BackBeat Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bing Yang, MD, Principal investigator, The Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382484
- Sponsor's protocol ID
- Acute FIM Study - China
- Status last verified
- Mar 2015
- First submitted
- 18 Feb 2015
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02382484
- Acronym / sponsor ID
- Acute FIM Study - China
- Conditions
- Hypertension
- Keywords
- Hypertension Resistant to Conventional Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- BackBeat Medical IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treatment |
Primary outcome
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
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
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
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
Assessment of any adverse effects
Time frame: Over a 24 hour period following the acute tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bing Yang, MD principal investigator
The Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A dual chamber pacing system (BackBeat Medical) in people with Hypertension, run by BackBeat Medical Inc at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.