TrialPath
← Back to searchRecruiting

Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment

NCT07403669 · Aventyn, Inc.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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
About this study
The interconnectedness between Diabetes, Heart disease and Kidney disease (Cardio Kidney Metabolic) has never been more important to recognize than the present day as the current data on the prevalence of this trifecta suggests an exponential increase in comorbidity, death, poor quality of life and a colossal economic burden on the society. Risk factors such as hypertension, high cholesterol, smoking, prediabetes states, obesity, unhealthy eating habits, lack of exercise, micro particle air pollution, high inflammatory markers, life stressors and genetics play a significant role in triggering the onset of these diseases and their complications. Half a Billion people in the world are expected to be having diabetes by 2023; another 150 million with prediabetes and one billion with hypertension ( Already 130Million in the US have Hypertension now ) Problem of Kidney Disease: More than 37 million Americans have kidney disease and millions more are at risk. According to the Centers for Disease Control and Prevention (CDC), 9 out of 10 people with early kidney disease don't know they have it because it usually has no symptoms until the late stages. Simple blood and urine tests can tell how well the kidneys are working. Diabetes and high blood pressure are the two leading causes of kidney disease. Kidney disease can lead to heart attack, stroke, kidney failure and death. With recent advances in research, Kidney disease can be treated if caught and treated early and it is often possible to slow or stop the progress of kidney disease with diet, exercise, lifestyle modifications and a few newer medications. Besides diabetes and high blood pressure, other common risks for kidney disease include having a family history of kidney disease, Black heritage, Hispanic, Asian American, or Native American. Black Americans are 3.4 times more likely than whites to develop kidney failure if over 60 years of age, and Hispanics are 1.5 times more likely than non- Hispanics to develop kidney failure. There are more than 785,000 people with kidney failure in the United States-an increase of more than 100% since 2000.
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
Study design
Enrollment target: 300 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-22
Estimated completion: 2027-04-22
Last updated: 2026-02-12
Interventions
Other: CHAPERONE AIDevice: CKMiq AIOther: Quality of Life
Primary outcomes
  • CHAPERONE AI Treatment (30 days, 90 days and 180 days in patients CKM)
Sponsor
Aventyn, Inc. · industry
With: Dignity Health, Arizona Heart Foundation, Arizona State University, University of Arizona, University of Phoenix College of Nursing, Creighton School of Medicine, Phoenix Arizona, Karolinska University Hospital, Partnership for Economic Innovation Arizona, Kanasu Labs, Intel Corporation
Contacts & investigators
ContactNavin Govind Steering Committtee, MS · contact · info@aventyn.com · 2317942328
ContactAditya Vijay, MS · contact · 2317942328
InvestigatorKris Vijay Study Chair, MD · study_chair, Aventyn, Inc.
InvestigatorZaki Lababidi PI, MD · principal_investigator, Gilbert Cardiology
All locations (5)
Fountains Family CareCompleted
Chandler, Arizona, United States
Gilbert CardiologyRecruiting
Gilbert, Arizona, United States
Arizona Heart FoundationRecruiting
Phoenix, Arizona, United States
East Valley DiabetesCompleted
San Tan Valley, Arizona, United States
Karolinska University HospitalNot Yet Recruiting
Stockholm, Sweden