Status:
COMPLETED
VL-3 Training Study
Lead Sponsor:
Riva Health
Collaborating Sponsors:
Diablo Clinical Research
University of Colorado, Denver
Conditions:
Hypertension
Blood Pressure
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The primary endpoints for this study are mean and standard deviation error measurements for the VLDBPM versus manual auscultation.
Detailed Description
This is a prospective, controlled, single-arm clinical evaluation. Five hundred thirty-two (532) subjects are planned to be evaluated. Each subject's blood pressure will be measured using the VLDBPM a...
Eligibility Criteria
Inclusion
- Male or female ≥18 and ≤ 85 years of age at the Baseline Visit.
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- A minimum of 30% of the data will be derived from male subjects; and a minimum of 30% of the data will be derived from female subjects.
- A minimum of 50 participants will have dark skin types, as defined by the Fitzpatrick Skin Type classification V or VI.
- Also, at least 10 participants should exhibit finger calluses, found typically on individuals who play stringed instruments frequently.
Exclusion
- 1\. Pregnant and/or breastfeeding. 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- 3\. Are unable or unwilling to undergo all assessments associated with the study.
- 4\. Have a history of poor quality or difficulty performing auscultation measurements.
- 5\. Subjects shall be excluded if the Korotkoff sound \[fifth phase (K5)\] is not audible 6. Subjects with vascular implants in the arm of measurement, such as those used for dialysis 7. Subject suffering from a medical condition prohibiting blood flow occlusion in either arms.
- 8\. Pre-existing conditions that may interfere with the accuracy or interpretation of auscultatory readings, such as aortic coarctation, arterial-venous malformation, occlusive arterial disease, or the presence of an antecubital bruit.
- 9\. Subjects who have known allergies to nitroglycerin (for subjects undergoing the nitroglycerin challenge).
- 10\. Subjects who have taken short acting nitroglycerin within 4 hours of the scheduled study. Such studies will be deferred for at least 4 hours.
- 11\. Subjects who have taken long acting nitroglycerin within 8 hours of the scheduled study. Such studies will be deferred for at least 8 hours.
- 12\. Subjects with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, or cardiac output is dependent upon venous return
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2021
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT05356754
Start Date
July 13 2020
End Date
November 8 2021
Last Update
May 2 2022
Active Locations (3)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Diablo Clinical Research
Walnut Creek, California, United States, 94398
3
University of Colorado Hospital
Aurora, Colorado, United States, 80045