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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Essential Hypertension; Primary Hypertension
• Intervention / Treatment: Device: Amicomed®; Other: Usual Care; Device: Digital Placebo

Detailed Description

Amicomed is a Digital therapeutics service and program for BP management and reduction. The key features of Amicomed include:

1. an automatic, expert system based, finite-machine AI algorithm for assessing the evolution of blood pressure levels,
2. 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.
3. 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.

• Study Type: Interventional
• Enrollment (Estimated): 316
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giovanni Gentile, MSc; Phone Number: +393282438545; Email: giovanni.gentile@newel.health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Subjects assigned to ID1 treatment arm will receive Amicomed® for 90 days, together with Usual Care (UC) procedures.	Device: Amicomed®; 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.; Other: Usual Care; Usual Care (UC): Subjects assigned to control group will receive care as usual care, including self-monitoring indications.
Placebo Comparator: Arm 2; Subjects assigned to ID2 treatment arm, will receive a digital Placebo, together with UC for 90 days.	Other: Usual Care; Usual Care (UC): Subjects assigned to control group will receive care as usual care, including self-monitoring indications.; Device: Digital Placebo; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any adverse events including device-related adverse events.	Any adverse events including device-related adverse events.	Baseline to Week 12; Baseline to Week 24

Collaborators and Investigators

• Sponsor: Newel Health SRL
• Investigators: Study Chair: Domenico Cianflone, MD, PhD, Newel Health SRL

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: NWL-AMD-CS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No