Assessment of Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension

Study Overview
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Brief Summary
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This is a multicenter, randomized, single-blind, parallel-group study to evaluate the efficacy and safety of Amicomed® compared with Usual Care (UC) over a 24-week treatment period in subjects with essential hypertension (mean, home based systolic blood pressure (SBP) ≥ 140 and/or diastolic blood pressure DBP ≥ 90 mm Hg on Day 1).

Detailed Description
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Amicomed is a Digital therapeutics service and program for BP management and reduction. The key features of Amicomed include: an automatic, expert system based, finite-machine AI algorithm for assessing the evolution of blood pressure levels, an automatic, expert system based, finite-machine AI algorithm for generating and delivering a detailed lifestyle program (dietary and physical activity) starting from the general lifestyle suggestions of the hypertension and cardiovascular prevention guidelines and producing a truly personalized program. a behavioral strategy embedded into the app to increase adherence and persistence into the program. The Amicomed Digital Therapeutics Service and App for hypertension management and intervention has been shown to significantly improve BP levels in case-control studies .These initial results demonstrated a 5mmHg systolic BP reduction across all Amicomed subscribers and 7.9 mmHg systolic BP reduction in subject with >= stage 1 hypertension. Comparable reduction of diastolic BP was also achieved. The aim of this study is to investigate the long-term efficacy of the Amicomed® Digital Therapeutics Program, compared to Usual Care, in reducing Systolic and Diastolic Blood Pressure in subjects with primary hypertension.

Official Title
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A Multicenter, Randomized, Parallel-Group, Single-Blind Study to Compare the Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension

Conditions
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Essential Hypertension, Primary Hypertension

Intervention / Treatment
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* Device: Amicomed®
* Device: Digital Placebo
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female with age ≥ 18 years Diagnosed with essential hypertension and exhibiting a mean home-based SBP ≥ 140 and/or DBP > 90mm Hg, i.e., Grade I Hypertension . Disease duration: 12 (+/-) 3 months Unmedicated, or currently treated by a stable regimen for hypertension with sub-optimal response to usual care treatments (Delta SBP < 5 mm Hg; and/or Delta DBP < 5 mm Hg) Not participating in physical exercise or dietary programs during the last 12 months from Visit 1. Willing and able to return for all clinic visits and to complete all study-required procedures Able to use the app, [self-report compliance over 80%]. Compliance is defined as the capacity to provide at least 6 BP measurements per week during the beginning, middle and end week of the 24 weeks program. Exclusion Criteria: Pregnancy or planning to become pregnant during the study period Use of medications that may interfere with the study intervention Severe kidney or liver disease Active cancer treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Subjects assigned to ID1 treatment arm will receive Amicomed® for 90 days, together with Usual Care (UC) procedures. | Device: Amicomed®<br>* This app helps users track their blood pressure readings over time with analysis and history features. It generates graphs and charts to display trends and patterns, and users can set reminders to take blood pressure readings. Additionally, the app offers personalized recommendations for lifestyle, including personalized diet plans, and physical exercise programs based on the user's information. Using cognitive-behavioral techniques and motivational levers, the app helps users overcome barriers to lifestyle changes and provides personalized feedback and coaching. It also includes a database of evidence-based strategies for behavior change, and users can receive notifications, reminders, and rewards to stay motivated.<br>Other: Usual Care<br>* Usual Care (UC): Subjects assigned to control group will receive care as usual care, including self-monitoring indications.<br>|
| Placebo Comparator: Arm 2<br>Subjects assigned to ID2 treatment arm, will receive a digital Placebo, together with UC for 90 days. | Device: Digital Placebo<br>* Subjects will be provided with a white label mobile app, which allows to (1) add blood pressure measurements, (2) access the history of recorded measurements. No notification system will be implemented.<br>Other: Usual Care<br>* Usual Care (UC): Subjects assigned to control group will receive care as usual care, including self-monitoring indications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Home Blood Pressure Monitoring - Systolic Blood Pressure | The primary endpoint is change from baseline to Week 12 in trough (approximately 7 days before the previous visit) Home BP SBP. Home BP is the average of all BP readings performed with a semiautomatic, validated BP monitor, for at least 3 days and preferably for 6-7 consecutive days before each clinic visit, with readings in the morning and the evening, taken in a quiet room after 5 min of rest, with the patient seated with their back and arm supported. Two measurements should be taken at each measurement session, performed 1-2 min apart. The primary endpoints will be collected using dedicated BP monitoring devices. Measurements taken for the purpose of efficacy assessment will not be reported to, nor shared or collected through the Investigational Device ID1. | Baseline to Week 12 | 
| Change in Home Blood Pressure Monitoring - Dyastolic Blood Pressure | The primary endpoint is change from baseline to Week 12 in trough (approximately 7 days before the previous visit) Home BP SBP. Home BP is the average of all BP readings performed with a semiautomatic, validated BP monitor, for at least 3 days and preferably for 6-7 consecutive days before each clinic visit, with readings in the morning and the evening, taken in a quiet room after 5 min of rest, with the patient seated with their back and arm supported. Two measurements should be taken at each measurement session, performed 1-2 min apart. The primary endpoints will be collected using dedicated BP monitoring devices. Measurements taken for the purpose of efficacy assessment will not be reported to, nor shared or collected through the Investigational Device ID1. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline to Week 24 in trough Home BP Systolic Blood Pressure | Change from baseline to Week 24 in trough (approximately 7 days before the previous visit) Home BP SBP. Home BP is the average of all BP readings performed with a semiautomatic, validated BP monitor, for at least 3 days and preferably for 6-7 consecutive days before each clinic visit, with readings in the morning and the evening, taken in a quiet room after 5 min of rest, with the patient seated with their back and arm supported. Two measurements should be taken at each measurement session, performed 1-2 min apart. The endpoints will be collected using dedicated BP monitoring devices. Measurements taken for the purpose of efficacy assessment will not be reported to, nor shared or collected through the Investigational Device ID1. | Baseline to Week 24 | 
| The change from baseline to Week 24 in trough Home BP Diastolic Blood Pressure | Change from baseline to Week 24 in trough (approximately 7 days before the previous visit) Home BP DBP. Home BP is the average of all BP readings performed with a semiautomatic, validated BP monitor, for at least 3 days and preferably for 6-7 consecutive days before each clinic visit, with readings in the morning and the evening, taken in a quiet room after 5 min of rest, with the patient seated with their back and arm supported. Two measurements should be taken at each measurement session, performed 1-2 min apart. The endpoints will be collected using dedicated BP monitoring devices. Measurements taken for the purpose of efficacy assessment will not be reported to, nor shared or collected through the Investigational Device ID1. | Baseline to Week 24 | 
| Percentage of responders at Week 12 Home BP SBP <140 mm Hg and/or reduction of ≥5 mm Hg from baseline. | Percentage of responders who show at Week 12 Home BP SBP <140 mm Hg and/or a reduction of ≥5 mm Hg from baseline. | Baseline to Week 12 | 
| Percentage of responders at Week 24 Home BP SBP <140 mm Hg and/or reduction of ≥5 mm Hg from baseline. | Percentage of responders who show at Week 24 Home BP SBP <140 mm Hg and/or a reduction of ≥5 mm Hg from baseline. | Baseline to Week 24 | 
| Percentage of responders at Week 12 Home BP DBP <90 mm Hg and/or reduction of ≥5 mm Hg from baseline. | Percentage of responders who show at Week 12 Home BP DBP <90 mm Hg and/or a reduction of ≥5 mm Hg from baseline. | Baseline to Week 12 | 
| Percentage of responders at Week 24 Home BP DBP <90 mm Hg and/or reduction of ≥5 mm Hg from baseline. | Percentage of responders who show at Week 24 Home BP DBP <90 mm Hg and/or reduction of ≥5 mm Hg from baseline. | Baseline to Week 24 | 
| Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg. | Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg. | Baseline to Week 12 | 
| Percentage of subjects achieving target blood pressure Home BP DBP <90 mm Hg. | Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg. | Baseline to Week 12 | 
| Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg and DBP <90 mm Hg. | Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg and DBP <90 mm Hg. | Baseline to Week 12 | 
| Percentage of subjects achieving target blood pressure Home BP DBP <80 mm Hg. | Percentage of subjects achieving target blood pressure Home BP DBP <80 mm Hg. | Baseline to Week 12 | 
| Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg. | Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg. | Baseline to Week 12 | 
| Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg and DBP <80 mm Hg. | Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg and DBP <80 mm Hg. | Baseline to Week 12 | 
| Mean changes in weight | Mean changes in weight, expressed in Kilograms (Kg) | Baseline to Week 12; Baseline to Week 24 | 
| Mean changes in BMI | Mean changes in Body Mass Index | Baseline to Week 12; Baseline to Week 24 | 
| Mean changes in waist circumference | Mean changes in waist circumference, expressed in centimeters (cm). | Baseline to Week 12; Baseline to Week 24 | 
| Mean change in points obtained by salt intake check sheet. | Mean change in points obtained by salt intake check sheet. | Baseline to Week 12; Baseline to Week 24 | 
| Amicomed(R) app usage rate | Amicomed(R) app usage rate: Percentage of usage of Amicomed(R) app | Baseline to Week 12; Baseline to Week 24 | 
| Amicomed(R) progress of app educational programs | Amicomed(R) progress of app educational programs | Baseline to Week 12; Baseline to Week 24 | 
| Rate of home BP measurements | Weekly Rate of home BP measurements | Baseline to Week 12; Baseline to Week 24 | 
| Malfunctions of the investigational medical device | Frequency of reported malfunctions of the investigational medical device | Baseline to Week 12; Baseline to Week 24 | 
| Percentage of subjects on medication for Hypertension | Percentage of subjects on medication for Hypertension | Baseline to Week 12; Baseline to Week 24 |