Atherosclerotic Cardiovascular Disease (ASCVD)TELE-CVRMNCT07208331
Evaluation of an Integrated, Digital, Nurse-led, Remote Monitoring Care Pathway for Cardiovascular Risk Management
An observational study of Atherosclerotic Cardiovascular Disease (ASCVD) and Hypertension, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The goal of this observational study is to evaluate the implementation of a structured, digital, nurse-led, remote monitoring care pathway for cardiovascular risk management (CVRM). Participants will receive this care as part of routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease (ASCVD), Hypertension, Dyslipidemia
- How many people
- 750 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Mar 2026to 30 Mar 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients enrolled in the digital CVRM program will be invited to participate in this registry.
Who may be able to join
- Age ≥18 years
- All patients enrolled in the program (high-risk and very high-risk patients)
Who cannot join
- Not able to provide informed consent
- No access to smartphone and/or tablet
- Inability to use digital tools required for the program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Cardiology Centers of the Netherlands (CCN)
Amsterdam, North Holland
Youri Schut, MSC, +31205668051, y.schut@cardiologiecentra.nl
About this study
The goal of this observational study is to evaluate the implementation of a structured, digital, nurse-led, remote monitoring care pathway for cardiovascular risk management (CVRM). Participants will receive this care as part of routine clinical practice. In addition to standard follow-up, participants will complete questionnaires on quality of life, medication adherence, system usability, and patient satisfaction.
Read the detailed description
CVRM is essential for patients at increased risk of cardiovascular disease (CVD) as well as for those with established atherosclerotic cardiovascular disease (ASCVD). Monitoring blood pressure and lipid profiles is crucial to achieving guideline-recommended targets. However, many patients fail to reach these targets despite the availability of effective therapies, resulting in an increased risk of recurrent events. Meanwhile, the burden of CVD continues to rise, creating significant pressure on healthcare systems.
A digital care pathway may improve therapy adherence and outcomes by enabling personalized, data-driven care. This study evaluates the effectiveness of a nurse-led, telemonitoring pathway for CVRM in routine practice, where patients measure their blood pressure and LDL-c levels at home. The study aims to improve risk stratification, support earlier intervention, and optimize lipid and blood pressure control, ultimately leading to better patient outcomes.
- Keywords
- Telemonitoring, Lipids, eHealth, Screening, Telemedicine, Risk factor management, Blood pressure
- Medical subject headings
- Atherosclerosis, Hypertension, Dyslipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients on-target for LDL-c
Proportion of patients achieving guideline-recommended LDL-c targets
Measured: Baseline and 1 year
Secondary outcomes (11)
Mean LDL-c
The mean of LDL-c values in mmol/L, measured at-home
Measured: Baseline and 1 year follow-up
Number of patients achieving blood pressure control
Proportion of patients achieving guideline-recommended blood pressure targets
Measured: Baseline and 1 year
Change in home-measured blood pressure values
Change in blood pressure values measured at home with telemonitoring in mmHg
Measured: Baseline and 1 year
Number of medication changes
Changes in lipid-lowering and antihypertensive medications, defined as change in dose and change in medication type
Measured: 1 year
5-item Medication Adherence Report Scale (MARS-5)
5 questions about medication adherence, with higher scores indicating better adherence
Measured: Baseline and 1 year
Visual Analog Scale (VAS) for medication adherence
The scale ranges from 0% to 100%, with higher scores indicating better medication adherence
Measured: Baseline and 1 year
Quality of life (QoL)
Using the EuroQoL-5D questionnaire
Measured: Baseline and 1 year
Telehealth Usability Questionnaire (TUQ)
18 questions on patient satisfaction and usability, with higher scores indicating better satisfaction
Measured: Baseline and 1 year
Hospitalization
Unplanned cardiovascular (re)hospitalization
Measured: 12 and 24 months
MACE
Cardiovascular death, myocardial infarction, any documented stroke (ischemic or hemorrhagic), ischemia-driven revascularization
Measured: 12 and 24 months
All-cause mortality
Total number of deaths from any cause
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start30 Mar 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular Disease (ASCVD)Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiology Centres of the Netherlands
- Responsible party
- Principal investigator, M.M. Winter, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208331
- Sponsor's protocol ID
- 2025.0543
- Acronym
- TELE-CVRM
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Integrated, Digital, Nurse-led, Remote Monitoring Care Pathway for Cardiovascular Risk Management
- ClinicalTrials.gov ID
- NCT07208331
- Acronym / sponsor ID
- TELE-CVRM / 2025.0543
- Keywords
- Telemonitoring, Lipids, eHealth, Screening, Telemedicine, Risk factor management, Blood pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Cardiology Centres of the Netherlands
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 6 Oct 2025 (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.
The goal of this observational study is to evaluate the implementation of a structured, digital, nurse-led, remote monitoring care pathway for cardiovascular risk management (CVRM). Participants will receive this care as part of routine clinical practice. In addition to standard follow-up, participants will complete questionnaires on quality of life, medication adherence, system usability, and patient satisfaction.
Detailed description
CVRM is essential for patients at increased risk of cardiovascular disease (CVD) as well as for those with established atherosclerotic cardiovascular disease (ASCVD). Monitoring blood pressure and lipid profiles is crucial to achieving guideline-recommended targets. However, many patients fail to reach these targets despite the availability of effective therapies, resulting in an increased risk of recurrent events. Meanwhile, the burden of CVD continues to rise, creating significant pressure on healthcare systems.
A digital care pathway may improve therapy adherence and outcomes by enabling personalized, data-driven care. This study evaluates the effectiveness of a nurse-led, telemonitoring pathway for CVRM in routine practice, where patients measure their blood pressure and LDL-c levels at home. The study aims to improve risk stratification, support earlier intervention, and optimize lipid and blood pressure control, ultimately leading to better patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients enrolled in the digital CVRM program will be invited to participate in this registry.
Key inclusion criteria (2 listed)
- Age ≥18 years
- All patients enrolled in the program (high-risk and very high-risk patients)
Key exclusion criteria (3 listed)
- Not able to provide informed consent
- No access to smartphone and/or tablet
- Inability to use digital tools required for the program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients on-target for LDL-c
Time frame: Baseline and 1 year
Proportion of patients achieving guideline-recommended LDL-c targets
11 secondary outcomes
Mean LDL-c
Time frame: Baseline and 1 year follow-up
Number of patients achieving blood pressure control
Time frame: Baseline and 1 year
Change in home-measured blood pressure values
Time frame: Baseline and 1 year
Number of medication changes
Time frame: 1 year
5-item Medication Adherence Report Scale (MARS-5)
Time frame: Baseline and 1 year
Visual Analog Scale (VAS) for medication adherence
Time frame: Baseline and 1 year
Quality of life (QoL)
Time frame: Baseline and 1 year
Telehealth Usability Questionnaire (TUQ)
Time frame: Baseline and 1 year
Hospitalization
Time frame: 12 and 24 months
MACE
Time frame: 12 and 24 months
All-cause mortality
Time frame: 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease (ASCVD) and Hypertension, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youri Schut, MSc (+31205668051, y.schut@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients on-target for LDL-c (time frame: Baseline and 1 year). 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 9 Oct 2026.