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

NCT06091176 | Unknown

• 1 other identifier: NWL-AMD-CS-001
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Essential Hypertension; Primary Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (21)

• The change from baseline to Week 24 in trough Home BP Systolic Blood Pressure

  Baseline to Week 24

• The change from baseline to Week 24 in trough Home BP Diastolic Blood Pressure

  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.

  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.

  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.

  Baseline to Week 12

Other Outcomes (1)

• Any adverse events including device-related adverse events.

  Baseline to Week 12; Baseline to Week 24

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Device: Amicomed®; Other: Usual Care

Arm 2

PLACEBO COMPARATOR

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

Device: Digital Placebo; Other: Usual Care

Interventions

Amicomed® DEVICE

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.

Arm 1

Digital Placebo DEVICE

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.

Arm 2

Usual Care OTHER

Usual Care (UC): Subjects assigned to control group will receive care as usual care, including self-monitoring indications.

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Newel Health SRL: lead

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Domenico Cianflone, MD, PhD

  Newel Health SRL

  STUDY CHAIR

Central Study Contacts

Giovanni Gentile, MSc

CONTACT

+393282438545; giovanni.gentile@newel.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: November 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: October 31, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share