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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  
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 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  
Status 
Not Applicable 
 
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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