COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

Status Recruiting

Clinical Trial Summary

The COOL-BP study is part of the Remote Hypertension Program and will investigate the data provided by Aktiia Bracelet (a cuffless Blood Pressure monitor at the wrist) when integrated into the Remote Hypertension Program. The COOL BP study aims to compare weekly and monthly Blood Pressure averages measured manually by traditional Home Blood Pressure Monitoring to those measured automatically by the Aktiia bracelet.

Clinical Trial Description

This is a prospective open-label single arm study. The investigational device of this study is the Aktiia Bracelet device. Aktiia Bracelet is a non-invasive blood pressure (BP) monitor intended to track systolic and diastolic Blood Pressure trends. The Aktiia Bracelet can also measure heart rate. Participants who consent to participate in COOL-BP will be shipped an Aktiia device to partipants residence. For 6 months, patient will continue the procedures of the Remote Hypertension Program in parallel to wearing the Aktiia Bracelet. The Remote Hypertension Program is run remotely according to a clinical algorithm, where study navigators contact patient sat regular intervals and monitor symptoms by regular phone calls; laboratory tests are obtained to ensure safety of the protocol's prescribed medications. Any symptoms will be evaluated by the program nurse practitioner or physician and managed per standard of care. During the study, the patient completes several surveys to give opinion on Aktiia product versus Home Blood Pressure Monitoring. Following six months of using the Aktiia.product, the participant's participation in this study will end. Participants continued participation in the Remote Hypertension Program will depend on whether participants have met the blood pressure goals outlined in that program. ;

Study Design

Related Conditions & MeSH terms

Hypertension

Clinical Trial Details

NCT number	NCT05211648
Study type	Interventional
Source	Aktiia SA
Contact	Josep Sola, PhD
Phone	+41797689800
Email	[email protected]
Status	Recruiting
Phase	N/A
Start date	February 10, 2022
Completion date	May 2023

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04591808` - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia	Phase 3
Recruiting	`NCT04515303` - Digital Intervention Participation in DASH
Completed	`NCT03093532` - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Completed	`NCT04082585` - Total Health Improvement Program Research Project
Not yet recruiting	`NCT04922424` - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men	Phase 1
Recruiting	`NCT05087290` - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Recruiting	`NCT05062161` - Sleep Duration and Blood Pressure During Sleep	N/A
Not yet recruiting	`NCT05038774` - Educational Intervention for Hypertension Management	N/A
Active, not recruiting	`NCT03875768` - Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure	N/A
Completed	`NCT04303468` - Intervention With a GABA Supplement in Prediabetics	N/A
Completed	`NCT03632668` - Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072	Phase 1
Recruiting	`NCT02699645` - Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial	Phase 3
Completed	`NCT03170752` - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP)	N/A
Recruiting	`NCT04452331` - Assessing Open Access Audio	N/A
Active, not recruiting	`NCT03660631` - Dissemination of the Cardiovascular Risk Service	N/A
Completed	`NCT03929198` - Translation of Pritikin Program to the Community	N/A
Terminated	`NCT04051957` - Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury	Phase 2
Completed	`NCT00508365` - Evaluation of Potential for Orthostatic Hypotension in Elderly Hypertensives	Phase 1
Completed	`NCT00382564` - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease	N/A