Cardiovascular-Kidney-Metabolic Syndrome Registry | NCT07718789

NCT07718789

Overview

NCT ID: NCT07718789
Lead Sponsor: Centre for Chronic Disease Control, IndiaOTHER
Official Title: Cardiovascular-Kidney-Metabolic Syndrome Registry
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Jul 24, 2026Estimated
Primary Completion Date: Dec 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Adults ≥18 years visiting select tertiary care hospitals AND

Presenting with signs and/or symptoms of CKMS :

2.1. 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.

Exclusion Criteria:

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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 2,250Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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