| CTRI Number |
CTRI/2026/04/107286 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Heart Changes in COPD Patients Using ECG and Echocardiography at a Secondary Care Hospital in Ranchi |
|
Scientific Title of Study
|
Study of cardiac changes with help of ECG and 2D echocardiography in patients suffering from Chronic Obstructive Pulmonary Disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ganesh Sapkal |
| Designation |
DNB Medicine Resident, Department of General Medicine |
| Affiliation |
Gandhinagar Central Hospital, Ranchi |
| Address |
DNB Cell,Department of General Medicine
Gandhinagar Central Hospital, Gandhinagar Kanke Road Ranchi Jharkhand -834008
Ranchi
JHARKHAND
834008
India |
| Phone |
9156644900 |
| Fax |
|
| Email |
sapkal.ganeshmanohar80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjeet Kumar Singh |
| Designation |
Head of Department,Department of General Medicine |
| Affiliation |
Department of General Medicine,Gandhinagar Central Hospital, Ranchi |
| Address |
Department of General Medicine
Gandhinagar Central Hospital, Gandhinagar Kanke Road Ranchi Jharkhand -834008
Ranchi
JHARKHAND
834008
India |
| Phone |
9470367462 |
| Fax |
|
| Email |
dr9ranjeet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Sapkal |
| Designation |
DNB Medicine Resident, Department of General Medicine |
| Affiliation |
Department of General Medicine,Gandhinagar Central Hospital, Ranchi |
| Address |
Department of General Medicine
Gandhinagar Central Hospital, Gandhinagar Kanke Road Ranchi Jharkhand -834008
Ranchi
JHARKHAND
834008
India |
| Phone |
9156644900 |
| Fax |
|
| Email |
sapkal.ganeshmanohar80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional academic research Postgraduate thesis |
|
|
Primary Sponsor
|
| Name |
Gandhinagar Central Hospital, Ranchi, Jharkhand |
| Address |
Gandhinagar Central Hospital, Central Coalfields Limited, Kanke Road, Ranchi, Jharkhand 834008 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ranjeet Kumar Singh |
Gandhinagar Central Hospital |
Department of General Medicine
Kanke Road,Ranchi,Jharkhand- 834008,India
Ranchi
JHARKHAND |
9470367462
dr9ranjeet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MANIPAL HOSPITALS EASTERN INDIA PRIVATE LIMITED ETHICS COMMITTEE(FORMERLY BMMSH CREC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years or more with spirometry confirmed Chronic Obstructive Pulmonary Disease willing to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with valvular heart disease, congenital heart disease, ischemic heart disease, pericardial disease, cardiomyopathy, connective tissue disorders, hypertension, diabetes mellitus, renal failure, hypothyroidism, dyslipidemia, substance abuse affecting cardiac function, bronchiectasis, bronchiolitis obliterans, cystic fibrosis, ECG evidence of ischemia, or echocardiographic regional wall motion abnormality. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of cardiac changes involving right and left heart chambers in patients with Chronic Obstructive Pulmonary Disease assessed by ECG and two dimensional echocardiography with Doppler. |
Prevalence of cardiac changes involving right and left heart chambers in patients with Chronic Obstructive Pulmonary Disease assessed by ECG and two dimensional echocardiography with Doppler. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Demographic and clinical profile of patients with Chronic Obstructive Pulmonary Disease |
At enrollment |
| Severity and pattern of Chronic Obstructive Pulmonary Disease using chest X ray and spirometry |
At enrollment |
| Correlation of ECG and echocardiographic findings with severity of Chronic Obstructive Pulmonary Disease |
At the time of cardiac evaluation during the study visit |
| Comparison of cardiac findings between COPD patients and matched non COPD controls |
During study assessment after enrollment |
|
|
Target Sample Size
|
Total Sample Size="768"
Sample Size from India="768"
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)
|
08/04/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Chronic Obstructive Pulmonary Disease is associated with important cardiac complications including pulmonary hypertension, right ventricular dysfunction and cor pulmonale. This prospective observational study aims to assess cardiac changes in patients with Chronic Obstructive Pulmonary Disease using electrocardiography and two dimensional echocardiography with Doppler and to correlate these findings with disease severity. The study will also compare findings with matched non Chronic Obstructive Pulmonary Disease controls. |