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

Last updated: October 19, 2023
Sponsor: Newel Health SRL
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stress

Circulation Disorders

Williams Syndrome

Treatment

Usual Care

Digital Placebo

Amicomed®

Clinical Study ID

NCT06091176
NWL-AMD-CS-001
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female with age ≥ 18 years
  • Diagnosed with essential hypertension and exhibiting a mean home-based SBP ≥ 140and/or DBP > 90mm Hg, i.e., Grade I Hypertension .
  • Disease duration: 12 (+/-) 3 months
  • Unmedicated, or currently treated by a stable regimen for hypertension withsub-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 monthsfrom Visit 1.
  • Willing and able to return for all clinic visits and to complete all study-requiredprocedures
  • Able to use the app, [self-report compliance over 80%]. Compliance is defined as thecapacity to provide at least 6 BP measurements per week during the beginning, middleand end week of the 24 weeks program.

Exclusion

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 Design

Total Participants: 316
Treatment Group(s): 3
Primary Treatment: Usual Care
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
October 31, 2025

Study 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.