Cardiovascular-Kidney-Metabolic Syndrome Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre for Chronic Disease Control, India
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥18 years visiting select tertiary care hospitals AND
Willing and able to provide informed consent.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,250 Participants
are grouped into 1 trial groupGroup A: Adults with Cardiovascular-Kidney-Metabolic Syndrome (CKMS)
Trial outcomes
Primary outcomes
1
Stage-wise proportion of participants with Cardiovascular-Kidney-Metabolic Syndrome (CKMS) at Baseline
Time frame
6 monthsSecondary outcomes
1
Stage-wise proportion of participants with CKMS at six-months and 12-months.
Time frame
12 months2
Change in CKMS staging among participants at six-months and 12-months.
Time frame
12 months3
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 months4
Quality-of-life assessment using the EQ-5D-5L questionnaire at baseline, six-months, and 12-months.
Time frame
12 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre for Chronic Disease Control, India
Lead sponsor
Sun Pharmaceutical Industries Limited
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: