Acute MICHAPERONE-CKMNCT07403669
Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment
A study testing CHAPERONE AI, CKMiq AI and Quality of Life in people with Acute MI and Heart Failure, run by Aventyn, Inc. at 5 sites in 2 countries.
Trial summary
The primary objective of CHAPERONE solution is to evaluate the efficacy of engaging, assessing, and enabling long term treatment strategy with Health Artificial Intelligence (AI) Chatbot, Copilot, Large Language Model (LLM) and vital sign monitoring device in reducing CKM disease burden using an algorithm obtained… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute MI, Heart Failure, Diabetes Mellitus
- What is being tested?
- CHAPERONE AI, CKMiq AI and Quality of Life
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 22 Oct 2025to 22 Apr 2027
- Phase
- Interventional
- 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
Who may be able to join
- Men and women over 18 years of age are included
- Eligible subjects must have one of the risk factor/ disease component of CKM:
- Diabetes with A1C of 7.5 or higher;
- or Heart disease with stent placement;
- or Coronary Artery Bypass Graft (CABG) in the last 12 months;
- or Chronic Kidney Disease (CKD) stage 2- 4
- and, in those with Heart failure, a recent hospitalization within one week of enrollment is required
Who cannot join
- Those subjects who are not willing to sign an informed consent
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Aditya Vijay, MS contact
5 sites in 2 countries
United States4 sites, 2 recruiting
- Completed
Fountains Family Care
Chandler, Arizona, 85248
- Recruiting
Gilbert Cardiology
Gilbert, Arizona, 85297
Sharolyn McClurg Coordinator, MSN, CNP
- Recruiting
Arizona Heart Foundation
Phoenix, Arizona, 85014
Eileen Spengler, RCS, FASE
Eileen Spengler, RCS, FASE
- Completed
East Valley Diabetes
San Tan Valley, Arizona, 85143
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinska University Hospital
Stockholm
Marcus Stahlberg, MD
Marcus Stahlberg, MD
About this study
Official title: Cardiovascular Kidney and Metaboolic (CKM) Health Assessment and Patient Empowerment in chROnic Disease Using a Health Coach INtervention ModEl: A Randomized Clinical Trial
The primary objective of CHAPERONE solution is to evaluate the efficacy of engaging, assessing, and enabling long term treatment strategy with Health Artificial Intelligence (AI) Chatbot, Copilot, Large Language Model (LLM) and vital sign monitoring device in reducing CKM disease burden using an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment.
Read the detailed description
The interconnectedness between Diabetes, Heart disease and Kidney disease (Cardio Kidney Metabolic) has never been more important to recognize than the present day as the current data on the prevalence of this trifecta suggests an exponential increase in comorbidity, death, poor quality of life and a colossal economic burden on the society. Risk factors such as hypertension, high cholesterol, smoking, prediabetes states, obesity, unhealthy eating habits, lack of exercise, micro particle air pollution, high inflammatory markers, life stressors and genetics play a significant role in triggering the onset of these diseases and their complications. Half a Billion people in the world are expected to be having diabetes by 2023; another 150 million with prediabetes and one billion with hypertension ( Already 130Million in the US have Hypertension now )
Problem of Kidney Disease:
More than 37 million Americans have kidney disease and millions more are at risk. According to the Centers for Disease Control and Prevention (CDC), 9 out of 10 people with early kidney disease don't know they have it because it usually has no symptoms until the late stages. Simple blood and urine tests can tell how well the kidneys are working. Diabetes and high blood pressure are the two leading causes of kidney disease. Kidney disease can lead to heart attack, stroke, kidney failure and death. With recent advances in research, Kidney disease can be treated if caught and treated early and it is often possible to slow or stop the progress of kidney disease with diet, exercise, lifestyle modifications and a few newer medications. Besides diabetes and high blood pressure, other common risks for kidney disease include having a family history of kidney disease, Black heritage, Hispanic, Asian American, or Native American. Black Americans are 3.4 times more likely than whites to develop kidney failure if over 60 years of age, and Hispanics are 1.5 times more likely than non- Hispanics to develop kidney failure. There are more than 785,000 people with kidney failure in the United States-an increase of more than 100% since 2000.
- Conditions
- Acute MI, Heart Failure, Diabetes Mellitus, Kidney Disease
- Being tested
- CHAPERONE AI, CKMiq AI, Quality of Life
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHAPERONE AIOther
The primary objective of this study is to evaluate the efficacy of treatment strategy on the impact of an intervention that is AI, Machine Learning (ML) based using Chatbot and Copilot with algorithm based intervention in CKM subjects in reducing progression of CKM diseases. This will be based on an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment. Improvement of patient outcomes will be measured by reduction of composite of Kidney failure/progression of kidney disease, Heart failure, acute myocardial infarction (AMI) events and diabetes complications and hospitalization as well as all-cause mortality through 30 days, 90 days and 180 days in CKM patients
CKMiq AIDevice
To evaluate the effect of treatment in: reducing readmission's from cardiovascular causes using an algorithm-based intervention of LIFE ESSENTIAL 8 biomarkers obtained from info graphic resources provided by American Heart Association. Improving subject self-assessed risk score overall well-being as measured by self-assessed Copilot Likert scale at 30 days, 90 days and 180 days from hospitalization. Increasing the number of days alive and outside the hospital from hospitalization through day 30, 90 and Day 180. Reducing the composite of cardiovascular re-hospitalization and cardiovascular mortality from hospitalization through 30, 90 and 180 days. New York Heart Association (NYHA) Class and Kansas City Cardiomyopathy Questionnaire (KCCQ) will be captured.
Quality of LifeOther
Also called CKM QOL
Secondary and tertiary objectives of this study are to evaluate the effect of CHAPERONE intervention in: Improving LIFE ESSENTIAL-8 Score and Health Related Quality of Life (HRQOL) measured with the 12-item Short Form (SF-12) survey, which reflects general health status and leads to 2 scores
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Placebo comparator | All qualified cardio kidney metabolic (CKM) patients including Congestive Heart Failure (CHF) subjects in Intervention Arm Receives: Other: CHAPERONE AI; Device: CKMiq AI; Other: Quality of Life |
| Control | No intervention | All qualified cardio kidney metabolic patients including CHF subjects in control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHAPERONE AI Treatment
Improvement of patient outcomes will be measured by reduction of composite of Kidney failure/progression of kidney disease, Heart failure, Acute Mi events and diabetes complications and hospitalization as well as all-cause mortality through 30 days, 90 days and 180 days in patients CKM
Measured: 30 days, 90 days and 180 days in patients CKM
Secondary outcomes (1)
CHAPERONE AI Reduced Readmissions
educing readmissions from cardiovascular causes using an algorithm-based intervention of LIFE ESSENTIAL 8 biomarkers obtained from infographic resources provided by American Heart Association , improving subject self-assessed risk score overall well-being as measured by self-assessed Copilot Likert scale at 30 days, 90 days and 180 days from hospitalization Increasing the number of days alive and outside the hospital from hospitalization through day 30, 90 and Day 180. Reducing the composite of cardiovascular re-hospitalization and Cardiovascular mortality from hospitalization through 30, 90 and 180 days. NYHA class and KCCQ will be captured
Measured: 30, 90 and 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start22 Oct 2025
- Primary completion22 Oct 2026 (estimated)
- Study completion22 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute MIStudies 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aventyn, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dignity Health, Arizona Heart Foundation, Arizona State University, University of Arizona, University of Phoenix College of Nursing, Creighton School of Medicine, Phoenix Arizona, Karolinska University Hospital, Partnership for Economic Innovation Arizona, Kanasu Labs, Intel Corporation
- Responsible party
- Sponsor
- Investigators
- Kris Vijay Study Chair, MD, Study chair, Aventyn, Inc.Zaki Lababidi PI, MD, Principal investigator, Gilbert Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403669
- Sponsor's protocol ID
- AVDH 008
- Acronym
- CHAPERONE-CKM
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Kidney and Metaboolic (CKM) Health Assessment and Patient Empowerment in chROnic Disease Using a Health Coach INtervention ModEl: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07403669
- Acronym / sponsor ID
- CHAPERONE-CKM / AVDH 008
- Conditions
- Acute MI, Heart Failure, Diabetes Mellitus, Kidney Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aventyn, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dignity Health, Arizona Heart Foundation, Arizona State University, University of Arizona, University of Phoenix College of Nursing, Creighton School of Medicine, Phoenix Arizona, Karolinska University Hospital, Partnership for Economic Innovation Arizona, Kanasu Labs, Intel Corporation
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 22 Oct 2026 (estimated)
- Study completion
- 22 Apr 2027 (estimated)
- First posted
- 11 Feb 2026 (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 primary objective of CHAPERONE solution is to evaluate the efficacy of engaging, assessing, and enabling long term treatment strategy with Health Artificial Intelligence (AI) Chatbot, Copilot, Large Language Model (LLM) and vital sign monitoring device in reducing CKM disease burden using an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment.
Detailed description
The interconnectedness between Diabetes, Heart disease and Kidney disease (Cardio Kidney Metabolic) has never been more important to recognize than the present day as the current data on the prevalence of this trifecta suggests an exponential increase in comorbidity, death, poor quality of life and a colossal economic burden on the society. Risk factors such as hypertension, high cholesterol, smoking, prediabetes states, obesity, unhealthy eating habits, lack of exercise, micro particle air pollution, high inflammatory markers, life stressors and genetics play a significant role in triggering the onset of these diseases and their complications. Half a Billion people in the world are expected to be having diabetes by 2023; another 150 million with prediabetes and one billion with hypertension ( Already 130Million in the US have Hypertension now )
Problem of Kidney Disease:
More than 37 million Americans have kidney disease and millions more are at risk. According to the Centers for Disease Control and Prevention (CDC), 9 out of 10 people with early kidney disease don't know they have it because it usually has no symptoms until the late stages. Simple blood and urine tests can tell how well the kidneys are working. Diabetes and high blood pressure are the two leading causes of kidney disease. Kidney disease can lead to heart attack, stroke, kidney failure and death. With recent advances in research, Kidney disease can be treated if caught and treated early and it is often possible to slow or stop the progress of kidney disease with diet, exercise, lifestyle modifications and a few newer medications. Besides diabetes and high blood pressure, other common risks for kidney disease include having a family history of kidney disease, Black heritage, Hispanic, Asian American, or Native American. Black Americans are 3.4 times more likely than whites to develop kidney failure if over 60 years of age, and Hispanics are 1.5 times more likely than non- Hispanics to develop kidney failure. There are more than 785,000 people with kidney failure in the United States-an increase of more than 100% since 2000.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Placebo comparator | Other: CHAPERONE AI, Device: CKMiq AI, Other: Quality of LifeAll qualified cardio kidney metabolic (CKM) patients including Congestive Heart Failure (CHF) subjects in Intervention Arm |
| Control | No intervention | –All qualified cardio kidney metabolic patients including CHF subjects in control arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women over 18 years of age are included
- Eligible subjects must have one of the risk factor/ disease component of CKM:
- Diabetes with A1C of 7.5 or higher;
- or Heart disease with stent placement;
- or Coronary Artery Bypass Graft (CABG) in the last 12 months;
Key exclusion criteria (1 listed)
- Those subjects who are not willing to sign an informed consent
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 |
|---|---|---|
| CHAPERONE AIThe primary objective of this study is to evaluate the efficacy of treatment strategy on the impact of an intervention that is AI, Machine Learning (ML) based using Chatbot and Copilot with algorithm based intervention in CKM subjects in reducing progression of CKM diseases. This will be based on an algorithm obtained from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment. Improvement of patient outcomes will be measured by reduction of composite of Kidney failure/progression of kidney disease, Heart failure, acute myocardial infarction (AMI) events and diabetes complications and hospitalization as well as all-cause mortality through 30 days, 90 days and 180 days in CKM patients | Other | Intervention |
| CKMiq AITo evaluate the effect of treatment in: reducing readmission's from cardiovascular causes using an algorithm-based intervention of LIFE ESSENTIAL 8 biomarkers obtained from info graphic resources provided by American Heart Association. Improving subject self-assessed risk score overall well-being as measured by self-assessed Copilot Likert scale at 30 days, 90 days and 180 days from hospitalization. Increasing the number of days alive and outside the hospital from hospitalization through day 30, 90 and Day 180. Reducing the composite of cardiovascular re-hospitalization and cardiovascular mortality from hospitalization through 30, 90 and 180 days. New York Heart Association (NYHA) Class and Kansas City Cardiomyopathy Questionnaire (KCCQ) will be captured. | Device | Intervention |
| Quality of LifeAlso: CKM QOLSecondary and tertiary objectives of this study are to evaluate the effect of CHAPERONE intervention in: Improving LIFE ESSENTIAL-8 Score and Health Related Quality of Life (HRQOL) measured with the 12-item Short Form (SF-12) survey, which reflects general health status and leads to 2 scores | Other | Intervention |
Primary outcome
CHAPERONE AI Treatment
Time frame: 30 days, 90 days and 180 days in patients CKM
Improvement of patient outcomes will be measured by reduction of composite of Kidney failure/progression of kidney disease, Heart failure, Acute Mi events and diabetes complications and hospitalization as well as all-cause mortality through 30 days, 90 days and 180 days in patients CKM
1 secondary outcome
CHAPERONE AI Reduced Readmissions
Time frame: 30, 90 and 180 days.
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 12 Feb 2026.
- 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.
Aditya Vijay, MS contact
Kris Vijay Study Chair, MD study chair
Aventyn, Inc.
Zaki Lababidi PI, MD principal investigator
Gilbert Cardiology
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHAPERONE AI, CKMiq AI and Quality of Life in people with Acute MI and Heart Failure, run by Aventyn, Inc. at 5 sites in 2 countries.
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 1 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Sweden. 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. 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?
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 Navin Govind Steering Committtee, MS (2317942328, info@aventyn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHAPERONE AI Treatment (time frame: 30 days, 90 days and 180 days in patients CKM). 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 12 Feb 2026.