| CTRI Number |
CTRI/2024/05/068130 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Investigating how well an echo test measuring the right hearts filling can predict how far someone with severe high blood pressure in the lungs can walk in 6 minutes |
|
Scientific Title of Study
|
Correlation of Right Ventricular diastolic function assessment by echo with six minute walk distance in patients with significant pulmonary artery hypertension |
| 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 Utukuru Nithin Kumar Reddy |
| Designation |
Cardiology DM Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Cardiology,3rd floor, Kasturba Medical College and Hospital,Manipal, Udupi, karnataka
Udupi KARNATAKA 576104 India |
| Phone |
9666517307 |
| Fax |
|
| Email |
nithinreddy.u@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Padmakumar R |
| Designation |
Professor and Head of Department of Cardiology, |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Cardiology,3rd floor, Kasturba Medical College and Hospital,Manipal, Udupi, karnataka
Udupi KARNATAKA 576104 India |
| Phone |
9900921428 |
| Fax |
|
| Email |
padmakumar69@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Padmakumar R |
| Designation |
Professor and Head of Department of Cardiology, |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Cardiology,3rd floor, Kasturba Medical College and Hospital,Manipal, Udupi, karnataka
Udupi KARNATAKA 576104 India |
| Phone |
9900921428 |
| Fax |
|
| Email |
padmakumar69@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical college, Manipal, Manipal Academy of Higher Education, Manipal, Udupu, Karnataka, India, Pincode 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical college, Manipal, Manipal Academy of Higher Education, Manipal |
| Address |
Kasturba Medical College and Hospital,Tiger circle, Madhava nagar, Manipal, Udupi, karnataka, 576104 |
| 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 Utukuru Nithin Kumar Reddy |
Kasturba hospital, Manipal |
Department of Cardiology,Room no.37,3rd floor, Kasturba Medical College and Hospital,Manipal, Udupi, karnataka Udupi KARNATAKA |
9666517307
nithinreddy.u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I272||Other secondary pulmonary hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between age group of 18 – 65 years with echo suggestive of significant pulmonary
hypertension (TR velocity ≥ 3.4m/s) without pulmonary stenosis.
2.Patients with Type 1, 4, and 5 Pulmonary Artery Hypertension. |
|
| ExclusionCriteria |
| Details |
Patients with locomotion disorder.
Patients with Anemia [Hb less than 10.0 g/dl ].
Pregnant patients.
Doppler echo showing e and a fusion.
Not willing to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome measured in this study will be the distance covered in six minutes and its correlation with echo parameters of right ventricular diastolic function in patient with significant pulmonary artery hypertension |
Primary outcome measured in this study will be the distance covered in six minutes and its correlation with echo parameters of right ventricular diastolic function in patient with significant pulmonary artery hypertension at the time of visit to the hospital. There will be no need for additional visits or follow ups in this study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Distance covered in six minutes & its correlation with echo parameters of right ventricular systolic function in patient with significant pulmonary artery hypertension |
Distance covered in six minutes & its correlation with echo parameters of right ventricular systolic function in patient with significant pulmonary artery hypertension at the time of visit to the hospital. There will be no need for additional visits or follow ups in this study. |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
11/06/2024 |
| 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="4" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
At the outset, we will obtain necessary approvals, including IRC (Institutional Review Committee), IEC (Institutional Ethics Committee) approval, and registration with CTRI (Clinical Trials Registry - India). Our study will focus on patients aged between 18 and 65 years, with echo suggestive of Significant pulmonary artery hypertension (TR velocity > 3.4m/s) in Kasturba Hospital, Manipal. Before the study, we will approach these patients and provide a detailed explanation of the research. Upon their understanding and agreement, informed consent will be obtained. Demographic details, clinical, laboratory valves and treatment receiving will be collected using proforma. Standard echocardiographic parameters which are required for the study will be recorded. They are advised to undergo six minute walk distance as per the ATS guidelines, under the supervision of certified cardiac rehabilitation physiotherapist and Cardilogy DM resident. Following this, Correlation of 6 minute walk distance with various 2d echo parameters of RV function will be analysed. There will be no need for additional visits or follow-up in this study. When standard protocols are followed, complications are rare. As noted previously, the self-paced character of the test limits their occurrence. The most common adverse event reported in the literature is oxygen desaturation below 80% resulting in termination of the test. Other complications include fatigue and mild shortness of breath, however patient will be doing six minute walk at his own pace. if such complications occur, he or she will be asked to stop the walk, as the six minute distance was under the supervision of certified cardiac rehabilitation physiotherapist and Cardilogy DM resident. The six minute walk test is routinely done in OPD settings to know functional capacity of patient.
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