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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Aventyn, Inc. Industry-sponsored |
| Locations | 5 sites (Chandler, Arizona and 4 other locations) |
| Status | Recruiting |
| Started | October 22, 2025 |
| Main results expected | October 22, 2026 |
| Study ends | April 22, 2027 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT07403669 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.