An observational study in Cardiovascular Kidney Metabolic Syndrome, sponsored by Centre for Chronic Disease Control, India. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Centre for Chronic Disease Control, India · Observational
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:
Participants will:
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.
Cardiovascular-Kidney-Metabolic Syndrome (CKMS) framework proposed by the American Heart Association to recognize the interconnected relationship between metabolic disorders, chronic kidney disease, and cardiovascular disease. Rather than considering these conditions independently, the CKMS framework emphasizes their shared pathophysiology and progressive nature, highlighting the need for integrated risk assessment and management across the disease spectrum.
India is experiencing a rapid rise in obesity, hypertension, type 2 diabetes mellitus, dyslipidaemia, chronic kidney disease, and cardiovascular disease. These conditions frequently coexist and contribute substantially to morbidity, mortality, and healthcare expenditure. Despite this growing burden, existing surveillance systems and disease registries primarily focus on individual diseases, resulting in fragmented information that limits understanding of how cardiovascular, kidney, and metabolic disorders interact and progress over time.
The absence of comprehensive real-world data on CKMS represents an important evidence gap in India. Understanding the distribution of CKMS stages, associated clinical characteristics, healthcare utilization, treatment practices, and longitudinal changes in disease status is essential for informing clinical practice, strengthening preventive strategies, and supporting healthcare policy. A multicentre registry provides an opportunity to systematically collect standardized clinical information from routine care settings and evaluate CKMS within the Indian healthcare context. Prospective observational registry of adults receiving routine clinical care to assess CKMS staging, progression, management, and outcomes without assignment of study interventions.
This registry has been established to generate prospective, real-world evidence on CKMS across tertiary care hospitals in India. Information collected through the registry will facilitate characterization of the CKMS spectrum, including demographic and clinical profiles, anthropometric measures, cardiometabolic risk factors, renal function, cardiovascular status, laboratory parameters, medication use, and patient-reported quality of life. Longitudinal follow-up will enable assessment of changes in disease stage and clinical characteristics during routine clinical care.
The registry is designed to reflect routine clinical practice without influencing treatment decisions. All diagnostic investigations, treatment decisions, and follow-up care will be performed according to the treating physician's clinical judgment and local standard of care. Participation in the registry will not require any experimental intervention or modification of routine medical management.
Data will be collected using standardized electronic case report forms within a secure REDCap database to ensure consistency across participating centres. Standardized operating procedures, investigator training, built-in data validation rules, centralized data monitoring, and routine quality assurance processes will be implemented to promote data completeness, accuracy, and consistency. Participant confidentiality will be maintained through coded study identifiers, restricted database access, secure storage systems, and compliance with applicable ethical, regulatory, and institutional data protection requirements.
The findings from this registry are expected to establish one of the first comprehensive multicentre datasets describing CKMS in the Indian population. The resulting evidence will improve understanding of the epidemiology and clinical profile of CKMS, support identification of high-risk populations, describe contemporary management practices, and provide a foundation for future observational studies, implementation research, clinical trials, and evidence-based strategies aimed at reducing the burden of cardiovascular, kidney, and metabolic diseases in India.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 2,250 is above the median of 506 across 1,572 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Centre for Chronic Disease Control, India is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presenting with signs and/or symptoms of CKMS :
2.1. Adiposity i.e., > 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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Stage-wise proportion of participants with Cardiovascular-Kidney-Metabolic Syndrome (CKMS) at Baseline
Time frame: 6 months
Stage-wise proportion of participants with CKMS at six-months and 12-months.
Time frame: 12 months
Change in CKMS staging among participants at six-months and 12-months.
Time frame: 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.
Time frame: 12 months
Quality-of-life assessment using the EQ-5D-5L questionnaire at baseline, six-months, and 12-months.
Time frame: 12 months
To capture prescription practices for CKMS.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No — Individual participant data (IPD) will not be shared because the registry contains confidential participant-level health information. De-identified, aggregated study results will be reported through scientific publications and presentations in accordance with applicable ethical, regulatory, sponsor, and institutional policies.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Centre for Chronic Disease Control, India