Clinical trial NCT06091176: Assessment of Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension
Official title: A Multicenter, Randomized, Parallel-Group, Single-Blind Study to Compare the Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Essential Hypertension
Primary Hypertension
Lead sponsor: Newel Health SRL
Sponsor class: INDUSTRY
First posted: 2023-10-19
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Home Blood Pressure Monitoring - Systolic Blood Pressure
timeFrame: Baseline to Week 12
measure: Change in Home Blood Pressure Monitoring - Dyastolic Blood Pressure
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: The change from baseline to Week 24 in trough Home BP Systolic Blood Pressure
timeFrame: Baseline to Week 24
measure: The change from baseline to Week 24 in trough Home BP Diastolic Blood Pressure
timeFrame: Baseline to Week 24
measure: Percentage of responders at Week 12 Home BP SBP <140 mm Hg and/or reduction of ≥5 mm Hg from baseline.
timeFrame: Baseline to Week 12
measure: Percentage of responders at Week 24 Home BP SBP <140 mm Hg and/or reduction of ≥5 mm Hg from baseline.
timeFrame: Baseline to Week 24
measure: Percentage of responders at Week 12 Home BP DBP <90 mm Hg and/or reduction of ≥5 mm Hg from baseline.
timeFrame: Baseline to Week 12
measure: Percentage of responders at Week 24 Home BP DBP <90 mm Hg and/or reduction of ≥5 mm Hg from baseline.
timeFrame: Baseline to Week 24
measure: Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg.
timeFrame: Baseline to Week 12
measure: Percentage of subjects achieving target blood pressure Home BP DBP <90 mm Hg.
timeFrame: Baseline to Week 12
measure: Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg and DBP <90 mm Hg.
timeFrame: Baseline to Week 12
measure: Percentage of subjects achieving target blood pressure Home BP DBP <80 mm Hg.
timeFrame: Baseline to Week 12
measure: Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg.
timeFrame: Baseline to Week 12
measure: Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg and DBP <80 mm Hg.
timeFrame: Baseline to Week 12
measure: Mean changes in weight
timeFrame: Baseline to Week 12; Baseline to Week 24
measure: Mean changes in BMI
timeFrame: Baseline to Week 12; Baseline to Week 24
measure: Mean changes in waist circumference
timeFrame: Baseline to Week 12; Baseline to Week 24
measure: Mean change in points obtained by salt intake check sheet.
timeFrame: Baseline to Week 12; Baseline to Week 24
measure: Amicomed(R) app usage rate
timeFrame: Baseline to Week 12; Baseline to Week 24
measure: Amicomed(R) progress of app educational programs
timeFrame: Baseline to Week 12; Baseline to Week 24
measure: Rate of home BP measurements
timeFrame: Baseline to Week 12; Baseline to Week 24
measure: Malfunctions of the investigational medical device
timeFrame: Baseline to Week 12; Baseline to Week 24
measure: Percentage of subjects on medication for Hypertension
timeFrame: Baseline to Week 12; Baseline to Week 24
Other outcomes:
measure: Any adverse events including device-related adverse events.
timeFrame: Baseline to Week 12; Baseline to Week 24
Locations:
Study officials:
affiliation: Newel Health SRL
name: Domenico Cianflone, MD, PhD
role: STUDY_CHAIR
References: