| CTRI Number |
CTRI/2020/08/027139 [Registered on: 14/08/2020] Trial Registered Prospectively |
| Last Modified On: |
29/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
LEFT VENTRICULAR FAILURE IN PATIENTS OF ACUTE EXACERBATION OF COPD |
|
Scientific Title of Study
|
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION IN PATIENTS OF ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Bagarhatta |
| Designation |
Post graduate doctor |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg , New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8130143634 |
| Fax |
|
| Email |
bagarhattaprachi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mradul Kumar Daga |
| Designation |
Director Professor |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg , New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604273 |
| Fax |
|
| Email |
drmraduldaga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prachi Bagarhatta |
| Designation |
Post graduate doctor |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg , New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8130143634 |
| Fax |
|
| Email |
bagarhattaprachi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Associated Lok Nayak Hospital , Bahadur Shah Zafar Marg, New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Bahadur Shah Zafar Marg, New Delhi , INDIA 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mradul Kumar Daga |
Maulana Azad Medical College and associated Lok Nayak Hospital , Bahadur Shah Zafar Marg , New delhi INDIA 110002 |
| Dr P Lali |
Maulana Azad Medical College and associated Lok Nayak Hospital , Bahadur Shah Zafar Marg , New delhi INDIA 110002 |
| Dr S Anuradha |
Maulana Azad Medical College and associated Lok Nayak Hospital , Bahadur Shah Zafar Marg , New delhi INDIA 110002 |
| Dr Vimal Mehta |
GB Pant Hospital , New Delhi 110002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prachi Bagarhatta |
Lok Nayak Hospital |
Department of General Medicine Lok Nayak Hospital Bahadur Shah Zafar Marg New Delhi
New Delhi
DELHI |
8130143634
bagarhattaprachi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maulana Azad Medical College and Associated Lok Nayak , Govind Ballabh Pant Hospital , Guru Nanak Eye Centre, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age 18 years or more with acute exacerbation of chronic obstructive pulmonary disease and ability to undergo echocardiography |
|
| ExclusionCriteria |
| Details |
Pulmonary embolism
Pneumonia
Pneumothorax
Renal Dysfunction
Acute coronary event
Valvular Heart Disease
Hepatic Dysfunction
Known case of Dilated Cardiomyopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the prevalence of ventricular systolic dysfunction in patients of acute exacerbation of chronic obstructive pulmonary disease |
Less than or equal to one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the correlation between NTproBNP levels and Left ventricular systolic dysfunction in acute exacerbation of COPD |
Less than or equal to one year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
29/08/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Purpose of trial - To evaluate prevalence of left ventricular systolic dysfunction in patients with acute exacerbation of COPD
Objectives -
Primary Objective-To evaluate the prevalence of left ventricular systolic dysfunction in patients with acute exacerbation of COPD
Secondary Objective - To determine correlation between NTpro BNP levels and left ventricular systolic dysfunction in patients with acute exacerbation of COPD
Some Major findings and references-
In a research study conducted by Winther et al. evaluating the diagnostic and prognostic significance of NT pro BNP in acute exacerbation of COPD and heart failure it was found to be a good marker to separate dyspnoea due to acute heart failure and not due to heart failure.
A study by Chang et al. analysed cardiac biomarkers in predicting mortality in acute exacerbation of COPD
In a study by Abroug et al. showed 31 % patients admitted in ICU for severe AE COPD had associated left heart dysfunction. NT pro BNP levels performed better to rule out than to rule in AECOPD with left dysfunction.An NT proBNp level of 1000pg/ml or less was the optimal cutoff to rule out an association of LV dysfunction with sensitivity of 94 % negative predictive value 94% and negative likelihood ratio of 0.08.
|