Essential HypertensionNCT06091176
Assessment of Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension
A study testing Amicomed® in people with Essential Hypertension and Primary Hypertension, run by Newel Health SRL.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension, Primary Hypertension
- What is being tested?
- Amicomed®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the detailed description
Amicomed is a Digital therapeutics service and program for BP management and reduction. The key features of Amicomed include:
- an automatic, expert system based, finite-machine AI algorithm for assessing the evolution of blood pressure levels,
- 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.
- 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.
- Conditions
- Essential Hypertension, Primary Hypertension
- Being tested
- Amicomed®, Digital Placebo, Usual Care
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Digital PlaceboDevice
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.
Usual CareOther
Usual Care (UC): Subjects assigned to control group will receive care as usual care, including self-monitoring indications.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Subjects assigned to ID1 treatment arm will receive Amicomed® for 90 days, together with Usual Care (UC) procedures. Receives: 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. Receives: Device: Digital Placebo; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 12
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 12
Mean changes in weight
Mean changes in weight, expressed in Kilograms (Kg)
Measured: Baseline to Week 12; Baseline to Week 24
Mean changes in BMI
Mean changes in Body Mass Index
Measured: Baseline to Week 12; Baseline to Week 24
Mean changes in waist circumference
Mean changes in waist circumference, expressed in centimeters (cm).
Measured: 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.
Measured: 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
Measured: Baseline to Week 12; Baseline to Week 24
Amicomed(R) progress of app educational programs
Amicomed(R) progress of app educational programs
Measured: Baseline to Week 12; Baseline to Week 24
Rate of home BP measurements
Weekly Rate of home BP measurements
Measured: Baseline to Week 12; Baseline to Week 24
Malfunctions of the investigational medical device
Frequency of reported malfunctions of the investigational medical device
Measured: Baseline to Week 12; Baseline to Week 24
Percentage of subjects on medication for Hypertension
Percentage of subjects on medication for Hypertension
Measured: Baseline to Week 12; Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Nov 2024 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newel Health SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Domenico Cianflone, MD, PhD, Study chair, Newel Health SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091176
- Sponsor's protocol ID
- NWL-AMD-CS-001
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-Group, Single-Blind Study to Compare the Efficacy and Safety of Amicomed®, for the Management of Essential Hypertension
- ClinicalTrials.gov ID
- NCT06091176
- Acronym / sponsor ID
- NWL-AMD-CS-001
- Conditions
- Essential Hypertension, Primary Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Newel Health SRLIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- an automatic, expert system based, finite-machine AI algorithm for assessing the evolution of blood pressure levels,
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Amicomed®, Other: Usual CareSubjects assigned to ID1 treatment arm will receive Amicomed® for 90 days, together with Usual Care (UC) procedures. |
| Arm 2 | Placebo comparator | Device: Digital Placebo, Other: Usual CareSubjects assigned to ID2 treatment arm, will receive a digital Placebo, together with UC for 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Arm 1 |
| Digital PlaceboSubjects 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. | Device | Arm 2 |
| Usual CareUsual Care (UC): Subjects assigned to control group will receive care as usual care, including self-monitoring indications. | Other | Arm 1, Arm 2 |
Primary outcome
Change in Home Blood Pressure Monitoring - Systolic Blood Pressure
Time frame: Baseline to Week 12
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.
Change in Home Blood Pressure Monitoring - Dyastolic Blood Pressure
Time frame: Baseline to Week 12
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.
21 secondary outcomes
The change from baseline to Week 24 in trough Home BP Systolic Blood Pressure
Time frame: Baseline to Week 24
The change from baseline to Week 24 in trough Home BP Diastolic Blood Pressure
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 24
Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg.
Time frame: Baseline to Week 12
Percentage of subjects achieving target blood pressure Home BP DBP <90 mm Hg.
Time frame: Baseline to Week 12
Percentage of subjects achieving target blood pressure Home BP SBP <140 mm Hg and DBP <90 mm Hg.
Time frame: Baseline to Week 12
Percentage of subjects achieving target blood pressure Home BP DBP <80 mm Hg.
Time frame: Baseline to Week 12
Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg.
Time frame: Baseline to Week 12
Percentage of subjects achieving target blood pressure Home BP SBP <130 mm Hg and DBP <80 mm Hg.
Time frame: Baseline to Week 12
Mean changes in weight
Time frame: Baseline to Week 12; Baseline to Week 24
Mean changes in BMI
Time frame: Baseline to Week 12; Baseline to Week 24
Mean changes in waist circumference
Time frame: Baseline to Week 12; Baseline to Week 24
Mean change in points obtained by salt intake check sheet.
Time frame: Baseline to Week 12; Baseline to Week 24
Amicomed(R) app usage rate
Time frame: Baseline to Week 12; Baseline to Week 24
Amicomed(R) progress of app educational programs
Time frame: Baseline to Week 12; Baseline to Week 24
Rate of home BP measurements
Time frame: Baseline to Week 12; Baseline to Week 24
Malfunctions of the investigational medical device
Time frame: Baseline to Week 12; Baseline to Week 24
Percentage of subjects on medication for Hypertension
Time frame: Baseline to Week 12; Baseline to Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Domenico Cianflone, MD, PhD study chair
Newel Health SRL
Questions about this trial
What is this clinical trial studying?
A study testing Amicomed® in people with Essential Hypertension and Primary Hypertension, run by Newel Health SRL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Gentile, MSc (+393282438545, giovanni.gentile@newel.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Home Blood Pressure Monitoring - Systolic Blood Pressure (time frame: Baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.