Cardiovascular-Kidney-Metabolic Syndrome Registry

NCT07718789 | Not Yet Recruiting

• 1 other identifier: CCDC_RID_2025_09
• Study Type: observational
• Target: 2,250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational registry study is to learn about cardiovascular-kidney-metabolic syndrome, also called CKMS, among adults receiving care at tertiary care hospitals in India. CKMS describes the close relationship between excess body weight, metabolic conditions such as high blood pressure and diabetes, kidney disease, and cardiovascular disease. The main questions this study aims to answer are:

• What proportion of participants are in each stage of CKMS when they enter the study?
• How do participants' CKMS stage and related health factors change over 12 months?
• How does participants' quality of life change over time?
• What are the prescription practices for CKMS? Participants will:
• Provide information about their general health, medical history, lifestyle, current medicines, family history, and quality of life.
• Have measurements taken, including height, weight, waist circumference, and blood pressure.
• Provide blood and urine samples for tests related to blood sugar, cholesterol, kidney function, inflammation, and heart health.
• Undergo an electrocardiogram, also called an ECG, and a coronary artery calcium scan according to the study schedule.
• Return for follow-up visits at 6 months and 12 months after joining the study. Participants will continue to receive their usual medical care as decided by their treating doctor. No experimental medicine or treatment will be provided as part of this study. This multi-centre registry will include approximately 2250 adults from five tertiary care hospitals in India. The information collected will help researchers understand the burden, progression, risk factors, quality of life, and treatment patterns of CKMS in India.

Conditions

Cardiovascular Kidney Metabolic Syndrome

Keywords

Cardiovascular-Kidney-Metabolic Syndrome (CKMS); Cardiovascular Disease; Cardiometabolic Health; Chronic Kidney Disease; Type 2 Diabetes Mellitus; Hypertension; Hyperglyceridaemia; Obesity; CKMS Staging; Registry

Outcome Measures

Primary Outcomes (1)

• Stage-wise proportion of participants with Cardiovascular-Kidney-Metabolic Syndrome (CKMS) at Baseline

  6 months

Secondary Outcomes (5)

• Stage-wise proportion of participants with CKMS at six-months and 12-months.

  12 months

• Change in CKMS staging among participants at six-months and 12-months.

  12 months

• Mean change in key clinical parameters (BMI, anthropometric measurements, BP, HbA1c, lipid profile, cardiac markers, eGFR, and ECG) at six-months and 12-months.

  12 months

• Quality-of-life assessment using the EQ-5D-5L questionnaire at baseline, six-months, and 12-months.

  12 months

• To capture prescription practices for CKMS.

  12 months

Study Arms (1)

Adults with Cardiovascular-Kidney-Metabolic Syndrome (CKMS)

Adults aged 18 years or older with Cardiovascular-Kidney-Metabolic Syndrome (CKMS) or CKMS-related risk factors who meet the study eligibility criteria and provide informed consent. Participants will receive routine clinical care and will be prospectively observed to assess CKMS staging, clinical characteristics, risk factors, prescription practices, quality of life, and disease progression over time. No study-specific intervention will be assigned.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults receiving care at the outpatient departments of Cardiology and Internal Medicine at participating tertiary care hospitals in India who have Cardiovascular-Kidney-Metabolic Syndrome (CKMS) or CKMS-related risk factors and are managed under routine clinical practice. Eligible participants will be consecutively enrolled after providing written informed consent.

You may qualify if:

• Adults ≥18 years visiting select tertiary care hospitals AND
• Presenting with signs and/or symptoms of CKMS :
• Adiposity i.e., Body Mass Index \> 23, and/or large waist circumference \[women: ≥ 80 cm; men: ≥ 90 cm\] AND/OR 2.2. Metabolic syndrome i.e., new or a known case of hypertension, type-2 diabetes, dyslipidaemia, chronic kidney disease, and/or PCOS.
• AND/OR 2.3. Presenting with signs of subclinical CVD and/or with a history of clinical CVD with metabolic syndrome AND
• Willing and able to provide informed consent.

You may not qualify if:

• Stage 0 CKMS i.e., a healthy state characterized by normal body weight, absence of metabolic risk factors such as hypertension, type-2 diabetes, dyslipidemias, preserved kidney function with no evidence of CKD, and no subclinical or clinical manifestations of CVDs.
• Neuro-cognitive, psychiatric, or any surgical conditions which prevents in obtaining reliable clinical data.
• Any surgical and/or medical condition that is likely to prevent the participant from complying with the requirements of the study or completing the study.
• Participants already taking part in another clinical trial.
• Pregnant and/or lactating women.

Sponsors & Collaborators

• Centre for Chronic Disease Control, India: lead
• Sun Pharmaceutical Industries Limited: collaborator

MeSH Terms

Conditions

Cardiovascular Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2; Hypertension; Hypertriglyceridemia; Obesity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 22, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share