- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07718789
Cardiovascular-Kidney-Metabolic Syndrome Registry (CKMS Registry)
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Stage-wise proportion of participants with Cardiovascular-Kidney-Metabolic Syndrome (CKMS) at Baseline
Délai: 6 months
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Stage-wise proportion of participants with CKMS at six-months and 12-months.
Délai: 12 months
|
12 months
|
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Change in CKMS staging among participants at six-months and 12-months.
Délai: 12 months
|
12 months
|
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Mean change in key clinical parameters (BMI, anthropometric measurements, BP, HbA1c, lipid profile, cardiac markers, eGFR, and ECG) at six-months and 12-months.
Délai: 12 months
|
12 months
|
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Quality-of-life assessment using the EQ-5D-5L questionnaire at baseline, six-months, and 12-months.
Délai: 12 months
|
12 months
|
|
To capture prescription practices for CKMS.
Délai: 12 months
|
12 months
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies du système endocrinien
- Maladies vasculaires
- Processus pathologiques
- Troubles nutritionnels
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladie chronique
- Attributs de la maladie
- Maladies métaboliques
- Suralimentation
- Poids
- Troubles du métabolisme du glucose
- Diabète sucré
- Insuffisance rénale
- En surpoids
- Hyperlipidémies
- Dyslipidémies
- Troubles du métabolisme lipidique
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Obésité
- Hypertension
- Diabète sucré, Type 2
- Maladies cardiovasculaires
- Insuffisance rénale chronique
- Hypertriglycéridémie
Autres numéros d'identification d'étude
- CCDC_RID_2025_09
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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