Cardiovascular Kidney and Metabolic Health Assessment and Patient Empowerment (CHAPERONE-CKM)

Aventyn

Status: Enrolling

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

Treatments: Device: CKMiq AI; Other: Quality of Life; Other: CHAPERONE AI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07403669

AVDH 008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

Intervention

Placebo Comparator group

Description:

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

Treatment:

Other: CHAPERONE AI

Other: Quality of Life

Device: CKMiq AI

Control

No Intervention group

Description:

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