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Unattended vs Attended Blood Pressure for High Blood Pressure

N/A
Waitlist Available
Led By Paul Muntner, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mean screening systolic blood pressure of 110 to < 160 mm Hg at most recent visit
Mean screening diastolic blood pressure of 70 to <100 mm Hg at most recent visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights

Study Summary

This trial will test two methods of measuring blood pressure outside of a clinical setting. One is an automated machine in a clinic and the other is a novel home device. The goal is to see if either of these reduce the need for ambulatory monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute difference between unattended and attended blood pressure
Accuracy of measuring asleep blood pressure using a home blood pressure monitor as compared to using an ambulatory blood pressure monitor
Tolerability of wearing a home blood pressure monitor versus an ambulatory blood pressure monitor: questionnaires
Secondary outcome measures
Correlation between different blood pressure measurements and ACR
Correlation between different blood pressure measurements and LVMI

Trial Design

2Treatment groups
Experimental Treatment
Group I: Unattended vs Attended Blood PressureExperimental Treatment2 Interventions
Participants blood pressure will be measured three times attended and three times unattended using the Microlife WatchBP Office AFIB device. Whether investigators measure blood pressure attended first and then unattended or unattended first and then attended will be assigned using a random number generator. At visit 2, clinic blood pressure will be measured three times attended and three times unattended using the Microlife WatchBP Office AFIB device, as at visit 1, but in the reverse order.
Group II: ABPM vs HBPMExperimental Treatment2 Interventions
Participants will be fitted with either the Microlife WatchBP O3 ambulatory blood pressure monitoring device or instructed on how to use the Microlife WatchBP Home N home blood pressure device, depending on which they are assigned to complete first. The order in which participants undergo ambulatory or home blood pressure monitoring will be assigned through a random number generator.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,279,393 Total Patients Enrolled
Columbia UniversityOTHER
1,431 Previous Clinical Trials
2,460,182 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,309,984 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial extend beyond those aged 35 and younger?

"The demographic requirements for enrolment in this trial range from 19 to 87 years old. Additionally, there are separate trials available for those under 18 and over 65 respectively; 5 studies and 82 studies respectively."

Answered by AI

How many participants are being admitted to this experiment?

"Affirmative. Information on clinicaltrials.gov reflects that this research, which was initially posted July 2nd 2019, is actively searching for participants. Approximately 630 people are sought from two different medical centres."

Answered by AI

Are there still vacancies in this clinical experiment for volunteers?

"Affirmative. According to information present on clinicaltrials.gov, this medical experiment remains in the process of enrollment and was first uploaded on July 2nd 2019. The study necessitates 630 participants from two separate sites for completion."

Answered by AI

Am I eligible for participation in this trial?

"This clinical trial is searching for 630 participants, who must possess a normal blood pressure and be between 19 and 87 years old."

Answered by AI
~113 spots leftby Apr 2025