Evaluation of a Non-Invasive Electrocardiogram-Assisted Blood Pressure Monitor

Terminated

• Conditions: Hypertension; Obesity; Heart Failure; Atherosclerosis; Atrial Fibrillation

• Registration Number: NCT02053623
• Lead Sponsor: Health Parametrics Inc.

Brief 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). 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-02-01
• Study First Posted: 2014-02-03
• Study Start: 2015-04-02
• Primary Completion: 2015-05-21
• Study Completion: 2015-07-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accurate and Consistent Blood Pressure Measurement	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.

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada