NCT07403669

Brief 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 from biomarkers and diagnostics utilizing remote sensor driven technology tools, care coordination and patient empowerment.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Oct 2025

Geographic Reach
2 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Oct 2025Apr 2027

Study Start

First participant enrolled

October 22, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 4, 2026

Last Update Submit

February 10, 2026

Conditions

Acute MIHeart FailureDiabetes MellitusKidney Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    30 days, 90 days and 180 days in patients CKM

Secondary Outcomes (1)

  • CHAPERONE AI Reduced Readmissions

    30, 90 and 180 days.

Study Arms (2)

Intervention

PLACEBO COMPARATOR

All qualified cardio kidney metabolic (CKM) patients including Congestive Heart Failure (CHF) subjects in Intervention Arm

Other: CHAPERONE AIDevice: CKMiq AIOther: Quality of Life

Control

NO INTERVENTION

All qualified cardio kidney metabolic patients including CHF subjects in control arm

Interventions

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

Intervention
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.

Intervention
Quality of LifeOTHER

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

Also known as: CKM QOL
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Those subjects who are not willing to sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fountains Family Care

Chandler, Arizona, 85248, United States

COMPLETED

Gilbert Cardiology

Gilbert, Arizona, 85297, United States

RECRUITING

Arizona Heart Foundation

Phoenix, Arizona, 85014, United States

RECRUITING

East Valley Diabetes

San Tan Valley, Arizona, 85143, United States

COMPLETED

Karolinska University Hospital

Stockholm, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Heart FailureDiabetes MellitusKidney Diseases

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Kris Vijay Study Chair, MD

    Aventyn, Inc.

    STUDY CHAIR

  • Zaki Lababidi PI, MD

    Gilbert Cardiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Navin Govind Steering Committtee, MS

CONTACT

2317942328info@aventyn.com

Aditya Vijay, MS

CONTACT

2317942328

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

October 22, 2025

Primary Completion (Estimated)

October 22, 2026

Study Completion (Estimated)

April 22, 2027

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)SE(1)