HypertensionNCT02053623
Evaluation of a Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor
An observational study of Hypertension and Atrial Fibrillation, run by Health Parametrics Inc. at 1 site in Canada.
Trial summary
Approximately one billion people suffer from hypertension worldwide. At least 10% of this population, that is, 100 million people, also suffers from associated chronic conditions namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Atrial Fibrillation, Obesity
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 2 Apr 2015to 2 Jul 2015
- Phase
- Observational
- 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
Study population: We will recruit a minimum of 20 qualified adult patients who come to the catheterization lab at the University of Ottawa Heart Institute for an angiography. The patients will have at least one of the following chronic conditions: atrial fibrillation, obesity, atherosclerosis, and heart failure.
Who may be able to join
- Patients undergoing an angiography in the catheterization lab who also suffer from at least one of the following chronic conditions:
- Established diagnosis of AF.
- Obesity characterized by a BMI > 40 (extremely high, Class III).
- Established diagnosis of AS.
- Established diagnosis of HF.
- Age ≥ 18 years.
Who cannot join
- Patients unwilling or unable to comply with study requirements.
- Failure to sign the informed consent form.
- Age < 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Novel Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor Against Invasive Intra-Arterial Pressure Monitoring - A Pilot Study
Approximately one billion people suffer from hypertension worldwide. At least 10% of this population, that is, 100 million people, also suffers from associated chronic conditions namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF). Personal interaction with medical practitioners (doctors) and review of published clinical research confirms that current non-invasive automatic blood pressure (BP) monitors that rely on BP pulse analysis alone cannot provide accurate measurement due to the unpredictable/weak nature of BP pulses in the above-mentioned chronic conditions. Lack of accuracy in BP estimation can lead to wrong diagnoses and hence to complications such as stokes and heart attacks.
The Sponsor is developing a novel non-invasive BP monitor that is similar to existing automatic monitors yet is capable of acquiring and analyzing electrocardiogram (ECG) data in conjunction with BP pulse data to provide better and more accurate measurements in the above chronic conditions.
The objective of this clinical trial is to evaluate the performance of this ECG-assisted BP monitor against invasive BP measurements in a small group of patients who suffer from the above conditions.
- Conditions
- Hypertension, Atrial Fibrillation, Obesity, Heart Failure, Atherosclerosis
- Medical subject headings
- Hypertension, Atrial Fibrillation, Obesity, Heart Failure, Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate and Consistent Blood Pressure Measurement
We expect to demonstrate that our automated non-invasive ECG-assisted BP monitoring technology can provide accurate and consistent diastolic \& systolic pressure measurements in chronic patient conditions (namely AF, obesity, AS, and HF) in which current non-invasive oscillometric technologies tend to be unreliable.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study start2 Apr 2015
- Primary completion21 May 2015
- Study completion2 Jul 2015
Why it stopped: Technical issues \& lack of funds
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Parametrics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053623
- Sponsor's protocol ID
- HPI-219939
- Status last verified
- Feb 2017
- First submitted
- 30 Jan 2014
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor Against Invasive Intra-Arterial Pressure Monitoring - A Pilot Study
- ClinicalTrials.gov ID
- NCT02053623
- Acronym / sponsor ID
- HPI-219939
- Conditions
- Hypertension, Atrial Fibrillation, Obesity, Heart Failure, Atherosclerosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Technical issues \& lack of funds
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Health Parametrics Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Apr 2015 (actual)
- Primary completion
- 21 May 2015 (actual)
- Study completion
- 2 Jul 2015 (actual)
- First posted
- 3 Feb 2014 (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.
Approximately one billion people suffer from hypertension worldwide. At least 10% of this population, that is, 100 million people, also suffers from associated chronic conditions namely, atrial fibrillation (AF), obesity, arterial stiffness (AS), and heart failure (HF). Personal interaction with medical practitioners (doctors) and review of published clinical research confirms that current non-invasive automatic blood pressure (BP) monitors that rely on BP pulse analysis alone cannot provide accurate measurement due to the unpredictable/weak nature of BP pulses in the above-mentioned chronic conditions. Lack of accuracy in BP estimation can lead to wrong diagnoses and hence to complications such as stokes and heart attacks.
The Sponsor is developing a novel non-invasive BP monitor that is similar to existing automatic monitors yet is capable of acquiring and analyzing electrocardiogram (ECG) data in conjunction with BP pulse data to provide better and more accurate measurements in the above chronic conditions.
The objective of this clinical trial is to evaluate the performance of this ECG-assisted BP monitor against invasive BP measurements in a small group of patients who suffer from the above conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit a minimum of 20 qualified adult patients who come to the catheterization lab at the University of Ottawa Heart Institute for an angiography. The patients will have at least one of the following chronic conditions: atrial fibrillation, obesity, atherosclerosis, and heart failure.
Key inclusion criteria (6 listed)
- Patients undergoing an angiography in the catheterization lab who also suffer from at least one of the following chronic conditions:
- Age ≥ 18 years.
Key exclusion criteria (3 listed)
- Patients unwilling or unable to comply with study requirements.
- Failure to sign the informed consent form.
- Age < 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accurate and Consistent Blood Pressure Measurement
Time frame: 12 months
We expect to demonstrate that our automated non-invasive ECG-assisted BP monitoring technology can provide accurate and consistent diastolic \& systolic pressure measurements in chronic patient conditions (namely AF, obesity, AS, and HF) in which current non-invasive oscillometric technologies tend to be unreliable.
Results and safety
The study was stopped early (reason given: Technical issues \& lack of funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Atrial Fibrillation, run by Health Parametrics Inc. at 1 site in Canada.
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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 24 Feb 2017. 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 Canada. 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 was stopped early (reason given: Technical issues \& lack of funds). Results are not available in the source record.
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?
Accurate and Consistent Blood Pressure Measurement (time frame: 12 months). 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 24 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.