Cardiovascular, Kidney, and Metabolic Health Assessment with Patient Empowerment

Cardiovascular Kidney and Metaboolic (CKM) Health Assessment and Patient Empowerment in chROnic Disease Using a Health Coach INtervention ModEl: A Randomized Clinical Trial

This program will test whether an AI chatbot, large language model Copilot, and remote vital‑sign monitoring can help adults with diabetes, heart disease, or chronic kidney disease reduce their combined cardio‑kidney‑metabolic disease burden.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aventyn, Inc. (Industry-sponsored)
• Locations: 5 sites (Chandler, Arizona and 4 other locations)
• Trial ID: NCT07403669 on ClinicalTrials.gov

What this trial studies

This interventional project combines CHAPERONE AI, CKMiq AI, a Copilot LLM, and remote vital‑sign monitoring devices with biomarker‑driven algorithms to support care coordination and patient self‑management. Participants are adults with diabetes (A1c ≥7.5), recent coronary stent placement or CABG within 12 months, CKD stage 2–4, or recent heart‑failure hospitalization, enrolled at sites in Chandler, Gilbert, and Phoenix, Arizona. The program integrates digital coaching, automated risk scores from diagnostics, and sensor data to personalize treatment strategies and prompt clinical follow‑up. Primary outcomes target reduction in CKM disease burden and improvements in quality of life and healthcare utilization.

Who should consider this trial

Good fit: Adults 18 or older with one of the CKM components—diabetes with A1c ≥7.5, recent coronary stent or CABG within 12 months, or CKD stage 2–4—and for heart‑failure patients a recent hospitalization within one week of enrollment are the intended participants.

Not a fit: People unwilling to sign informed consent, those without the listed CKM risk factors, or individuals with more advanced kidney failure (for example dialysis or CKD stage 5) are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could help patients detect problems earlier, improve self‑management, and reduce complications and hospital visits related to combined heart, kidney, and metabolic disease.

How similar studies have performed: Remote monitoring and digital coaching programs have shown benefits in chronic disease management, but fully integrated LLM‑driven interventions for combined cardio‑kidney‑metabolic care are relatively novel and have limited direct validation so far.

Eligibility criteria

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

Where this trial is running

Chandler, Arizona and 4 other locations

• Fountains Family Care — Chandler, Arizona, United States (Completed)
• Gilbert Cardiology — Gilbert, Arizona, United States (Recruiting)
• Arizona Heart Foundation — Phoenix, Arizona, United States (Recruiting)
• East Valley Diabetes — San Tan Valley, Arizona, United States (Completed)
• Karolinska University Hospital — Stockholm, Sweden (Not_yet_recruiting)

Study contacts

• Principal investigator: Zaki Lababidi PI, MD — Gilbert Cardiology
• Study coordinator: Navin Govind Steering Committtee, MS

Conditions Acute MI; Heart Failure; Diabetes Mellitus; Kidney Disease