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

Newel Health

Status: Not yet enrolling

Conditions: Essential Hypertension; Primary Hypertension

Treatments: Other: Usual Care; Device: Digital Placebo; Device: Amicomed®

Study type: Interventional

Funder types: Industry

Identifiers

NCT06091176

NWL-AMD-CS-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 316 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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316 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Subjects assigned to ID1 treatment arm will receive Amicomed® for 90 days, together with Usual Care (UC) procedures.

Treatment:

Other: Usual Care

Device: Amicomed®

Arm 2

Placebo Comparator group

Description:

Subjects assigned to ID2 treatment arm, will receive a digital Placebo, together with UC for 90 days.

Treatment:

Other: Usual Care

Device: Digital Placebo