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CTRI Number  CTRI/2025/09/094404 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding Heart Disability and Its Effect on People’s Health and Lifestyle 
Scientific Title of Study   Cardiac Disability and its demographic and socioeconomic Correlate in tertiary care centre: A Qualitative and Quantitative Analysis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DEEPAK MAHESHWARI 
Designation  Professor Cardiology and Principal 
Affiliation  SMS Medical College and Hospital 
Address  SMS Medical College, Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004

Jaipur
RAJASTHAN
302004
India 
Phone  9829010252  
Fax    
Email  aishvyas95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aishwarya Vyas 
Designation  SR 
Affiliation  SMS Medical College, Jaipur 
Address  SMS Medical College, Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004

Jaipur
RAJASTHAN
302004
India 
Phone  9461916302  
Fax    
Email  aishvyas95@gmail.com  
 
Details of Contact Person
Public Query  
Name  Aishwarya Vyas 
Designation  SR 
Affiliation  SMS Medical College, Jaipur 
Address  SMS Medical College, Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004

Jaipur
RAJASTHAN
302004
India 
Phone  9461916302  
Fax    
Email  aishvyas95@gmail.com  
 
Source of Monetary or Material Support  
SMS Medical College, Jawahar Lal Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004 
 
Primary Sponsor  
Name  SMS Medical College and Hospital 
Address  Jawahar Lal Nehru (JLN) Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan - 302004 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aishwarya Vyas  SMS Medical College and Hospital  SMS Medical College, Jawahar Lal Nehru (JLN) Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan - 302004, India
Jaipur
RAJASTHAN 		 9461916302

aishvyas95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of ethics committee, SMS Medical College and attached hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I11||Hypertensive heart disease, (2) ICD-10 Condition: I20-I25||Ischemic heart diseases, (3) ICD-10 Condition: I30-I52||Other forms of heart disease, (4) ICD-10 Condition: I089||Rheumatic multiple valve disease,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Participants diagnosed with cardiac disability as per CDS-HDC classification categories A, B, or C (Mishra et al) will be included.
Group A: Heart diseases with mild or no hemodynamic abnormalities and low risk of progression such as small patent foramen ovale, small atrial septal defect, small patent ductus arteriosus, mild pulmonary stenosis, bicuspid aortic valve with mild regurgitation, Ebstein anomaly grade I or II, or repaired congenital heart disease without residual dysfunction. Heart diseases improved by palliative procedures such as mild hypertrophic cardiomyopathy, viral myocarditis, rheumatic heart disease, Kawasaki disease, or mild stenotic lesions are also included. Controlled systemic or pulmonary hypertension and mild arrhythmias such as Wolff-Parkinson-White syndrome are eligible.
Group B: Heart diseases with significant hemodynamic effects and moderate risk of progression such as pre- or post-tricuspid shunts, coronary arteriovenous fistula, Ebstein anomaly with moderate tricuspid regurgitation, congenital or degenerative valvular diseases, hypertrophic or dilated cardiomyopathy, coronary artery disease, and Marfan syndrome. Patients with residual lesions after corrective surgery such as repaired tetralogy of Fallot, transposition of great arteries, coarctation of aorta, or valvar disease are included. Heart diseases partially improved by palliation such as systemic to pulmonary artery shunt, pulmonary artery banding, or Senning or arterial switch palliation are also eligible. Moderate systemic or pulmonary hypertension and significant arrhythmias such as complete heart block, long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic ventricular tachycardia are included.
Group C: Heart diseases with severe hemodynamic abnormalities or those requiring intervention such as large shunts, Eisenmenger syndrome, severe obstructive or regurgitant lesions, complex cyanotic congenital heart diseases, advanced cardiomyopathies, severe valvular diseases, or significant coronary artery disease. Patients with persistent dysfunction, desaturation, arrhythmia, or hypertension after corrective surgery are included. Palliated heart diseases with ongoing dysfunction such as Fontan or total cavopulmonary connection complications, persistent cyanosis, or severe pulmonary hypertension are also included. Severe systemic or pulmonary hypertension with end-organ dysfunction and life-threatening arrhythmias such as ICD-dependent arrhythmias, arrhythmogenic right ventricular dysplasia, or intractable tachyarrhythmias are also eligible. 
 
ExclusionCriteria 
Details  Patients will be excluded if they have primary non-cardiac disabilities affecting daily functioning such as neurological, orthopedic, respiratory, or systemic causes unrelated to heart disease. Patients unwilling or unable to provide informed consent will be excluded. Patients unable to understand or respond reliably to the questionnaire, including those with severe cognitive impairment, language barriers, or illiteracy without caregiver support, will not be included. Patients who have undergone major cardiac surgery or intervention such as bypass grafting, valve replacement, device closure, or stenting within the last twelve months will be excluded. Patients with unstable hemodynamics, acute cardiac decompensation, or ongoing emergency cardiac procedures at the time of screening will not be eligible. Patients with severe psychiatric illness interfering with study participation or those currently enrolled in another interventional clinical trial will also be excluded. The principal investigator may exclude any participant considered unsuitable for safe and reliable participation. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quantify the occurrence of cardiac disability using the Global Disability Scale in a large tertiary care center in India.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the socioeconomic & demographic correlates of different levels of cardiac disability  4 weeks 
 
Target Sample Size   Total Sample Size="702"
Sample Size from India="702" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study aims to estimate the occurrence of cardiac disability among patients attending a tertiary care hospital and to evaluate its relationship with demographic and socioeconomic factors. Cardiac disability is defined as limitations in physical and functional capacity caused by heart diseases. The study will use the Cardiac Disability Score based on Heart Disease Categories to classify patients into mild, moderate, and severe disability groups. A mixed methods design will be used, combining quantitative and qualitative approaches. Quantitative data will include clinical assessments, echocardiographic findings, disability scoring, and structured questionnaires. Qualitative data will include in depth interviews and focus group discussions to explore the personal, social, and financial impact of living with cardiac disability. The findings are expected to provide insights into the burden of cardiac disability, its socioeconomic impact, and the gaps in healthcare access and social support. Results will help guide future healthcare planning and policy development for individuals living with cardiac disability. 
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