Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Cardiovascular, Kidney, and Metabolic Health Assessment with Patient Empowerment

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

Run by Aventyn, Inc. · NCT07403669 · Data updated 2026-11-12

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.

More Heart Failure trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorAventyn, Inc.
Industry-sponsored
Locations5 sites (Chandler, Arizona and 4 other locations)
StatusRecruiting
StartedOctober 22, 2025
Main results expectedOctober 22, 2026
Study endsApril 22, 2027
Registry record updatedFebruary 12, 2026
Trial IDNCT07403669 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Gilbert Cardiology
    Gilbert, Arizona, United States
    Recruiting
  • Arizona Heart Foundation
    Phoenix, Arizona, United States
    Recruiting
  • Fountains Family Care
    Chandler, Arizona, United States
    Completed
  • 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
  • Email: info@aventyn.com
  • Phone: 2317942328

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.