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Digital Hypertension Management System
Digital Hypertension Management for High Blood Pressure (HrtEx Trial)
N/A
Recruiting
Led By Paul J Wang, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≤ 2 current anti-HTN meds
Age 30-90 yrs.
Must not have
Heart failure with reduced ejection fraction (EF < 40%)
Prior solid organ transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 (baseline), visit-3 (6 month follow up)
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two treatments to see which is more effective. Results are analyzed from two groups of people.
Who is the study for?
This trial is for adults aged 30-90 with high blood pressure who own a smartphone and are currently on no more than two blood pressure medications. They must be able to increase the dosage or add at least two types of certain blood pressure drugs, and speak English or Spanish. People can't join if they're pregnant, have specific heart or kidney conditions, recently had a heart attack or stroke, were hospitalized for severe hypertension, or had an organ transplant.
What is being tested?
The study compares a digital system that helps manage high blood pressure against the usual care methods. Participants will be randomly assigned to one of these two groups in this parallel-design trial to see which is more effective at controlling their condition.
What are the potential side effects?
Since this trial involves standard hypertension treatments compared with digital management tools rather than new medications, side effects may not apply as typically seen in drug trials but could include issues related to medication adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am taking 2 or fewer medications for high blood pressure.
Select...
I am between 30 and 90 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My heart's pumping ability is significantly reduced.
Select...
I have had a solid organ transplant.
Select...
I am on dialysis.
Select...
My kidneys are failing (GFR <15).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit-1 (baseline), visit-3 (6 month follow up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit-1 (baseline), visit-3 (6 month follow up)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Defined Daily Dose (DDD)
Secondary study objectives
Antihypertensive Drugs
Clinician inertia
Diastolic blood pressure (DBP)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mobile Health TechnologyExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,469 Previous Clinical Trials
17,501,547 Total Patients Enrolled
Santa Clara Valley Medical CenterOTHER
16 Previous Clinical Trials
2,190 Total Patients Enrolled
The Cooper Health SystemOTHER
80 Previous Clinical Trials
35,327 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking 2 or fewer medications for high blood pressure.I have not had a heart attack or stroke in the last 6 months.My heart's pumping ability is significantly reduced.I have had a solid organ transplant.I am between 30 and 90 years old.I am on dialysis.I speak English or Spanish.My kidneys are failing (GFR <15).I was hospitalized for a severe hypertension crisis in the last 6 months.I can start or increase the dose of at least 2 types of heart medications.Your blood pressure at the doctor's office is 140 mm Hg or higher.You own a smartphone.
Research Study Groups:
This trial has the following groups:- Group 1: Mobile Health Technology
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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