Recruiting

Health AI

Sponsor:

Aventyn, Inc.

Code:

NCT07403669

Conditions

Acute MI

Heart Failure

Diabetes Mellitus

Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CHAPERONE AI

CKMiq AI

Quality of Life

Study Details

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.

Conditions

Acute MI

Heart Failure

Diabetes Mellitus

Kidney Disease

Study ID

NCT07403669

Start date

Oct 22, 2025

Status verified date

Feb, 2026

Completion date

Apr 22, 2027

Anticipated

Primary completion date

Oct 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Intervention

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

no intervention: Control

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

Interventions

CHAPERONE AI

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 AI

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 Life

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

Primary outcome measure

  • CHAPERONE AI Treatment [ Time Frame: 30 days, 90 days and 180 days in patients CKM ]

Central Contacts and Locations

Central contacts

Navin Govind Steering Committtee, MS

2317942328info@aventyn.com

Aditya Vijay, MS

2317942328

Locations

Gilbert Cardiology

Recruiting

Gilbert, Arizona, United States, 85297

Arizona Heart Foundation

Recruiting

Phoenix, Arizona, United States, 85014

More Information

Sponsor

Aventyn, Inc.

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Aventyn, Inc. on 2026-02-12.