FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078087 [Registered on: 13/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Prevalence of Pulmonary arterial hypertension and role of plasma NEDD 9 in newly diagnosed Graves disease patients 
Scientific Title of Study   Pulmonary arterial hypertension and plasma NEDD 9 in Graves disease and its alteration after normalization of thyroid hormones with antithyroid drugs 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pradosh Kumar Sahu 
Designation  D.M Resident ,Endocrinology 
Affiliation  MKCG Medical College & Hospital 
Address  Department of Endocrinology, 3rd floor, superspeciality block, MKCG Medical college Berhampur, Ganjam, Odisha

Ganjam
ORISSA
760004
India 
Phone  07846954848  
Fax    
Email  spradoshendo23@outlook.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Ravi Kumar 
Designation  Professor and Head 
Affiliation  MKCG Medical College & Hospital 
Address  3rd floor, Department of Endocrinology ss block, MKCG medical college, Berhampur

Ganjam
ORISSA
760004
India 
Phone  7008356202  
Fax    
Email  padala797@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pradosh Kumar Sahu 
Designation  D.M Resident ,Endocrinology 
Affiliation  MKCG Medical College & Hospital 
Address  Department of Endocrinology,3rd floor, superspeciality block, MKCG Medical college Berhampur, Ganjam, Odisha.

Ganjam
ORISSA
760004
India 
Phone  07846954848  
Fax    
Email  spradoshendo23@outlook.com  
 
Source of Monetary or Material Support  
Department of Endocrinology,M.K.C.G Medical college ,Berhampur,Ganjam,Odisha,760004 
 
Primary Sponsor  
Name  Pradosh Kumar Sahu 
Address  Department of Endocrinology, 3rd floor, superspeciality block M.K.C.G Medical college, Berhampur, Ganjam, Odisha 
Type of Sponsor  Other [self] 
 
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 Pradosh Kumar Sahu  MKCG MEDICAL COLLEGE  Room no:4 Endocrinology Outdoor, Department of endocrinology, superspeciality block, Ground floor
Ganjam
ORISSA 		 07846954848

spradoshendo23@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, M.K.C.G MEDICAL COLLEGE, BRAHMAPUR,GANJAM.(ODISHA)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E050||Thyrotoxicosis with diffuse goiter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Tab Carbimazole  Tab Carbimazole (5mg) was given to newly diagnosed Graves disease patients according to their serum free T3 and free T4 level to achieve euthyroidism. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Newly detected Graves’ disease patients
2.Age ≥ 18 years
 
 
ExclusionCriteria 
Details  1.Preexisting cardiovascular disease (significant valvular heart disease, coronary artery disease, dilated or hypertrophic cardiomyopathy, congestive heart failure, and arrhythmias)
2.History of pulmonary thromboembolism or significant pulmonary disease
3.Autoimmune connective tissue disease (Systemic sclerosis, Antiphospholipid antibody syndrome, Vasculitis, Rheumatoid arthritis)
4.Use of anorectic agents (aminorex, fenfluramine, and dexfenfluramine)
5. Known malignancies that can affect plasma NEDD 9 level (carcinoma of the breast, melanoma, T-cell leukemia, glioblastoma, colorectal carcinoma, Acute myeloid leukemia, chronic myeloid leukemia, Adenocarcinoma of lungs, carcinoma of oropharynx)
6. Non-malignant conditions known to affect plasma NEDD 9 like CVA, Polycystic kidney disease.
7. Infections that can produce secondary pulmonary arterial hypertension like HIV, HCV Infection
8. Pregnancy
9. Current smoker
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To estimate the prevalence of Pulmonary arterial hypertension in Grave’s disease patients and its reversibility with treatment with antithyroid drugs (Thionamides).
2.To compare the plasma NEDD 9 level in newly diagnosed Grave’s disease patients with pulmonary arterial hypertension and without PAH at baseline.
3.To compare the plasma NEDD 9 level in newly diagnosed Grave’s disease patients with pulmonary arterial hypertension before and after treatment. 		 1 YEAR 
 
Secondary Outcome  
Outcome  TimePoints 
1.To look for a correlation of TSH receptor antibody and anti-TPO antibody with pulmonary arterial hypertension in newly diagnosed Grave’s disease patients.  1 YEAR 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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   Phase 4 
Date of First Enrollment (India)   25/12/2024 
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="0"
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  

The prevalence of pulmonary arterial hypertension will be assessed by 2D-Echocardiography (mPAP >20mm of Hg) in newly detected Grave’s disease patients presenting to OPD of the Department of Endocrinology, MKCG Medical College & Hospital, Berhampur. They will be treated as per protocol and the normalization of pulmonary arterial pressure will be reassessed after achieving an euthyroid state. The novelty of our study is we will also assess the plasma level of NEDD 9 in newly detected Grave’s disease patients with pulmonary arterial hypertension (PAH) in comparison to the non-PAH group. We will also assess for change in Plasma NEDD 9 level after normalization of pulmonary arterial hypertension to know whether NEDD9 plays any role in pathogenesis in the development of PAH. There is a role of thyroid autoimmunity in the development of pulmonary arterial hypertension. We will look for a correlation between the TSH receptor antibody and the anti-TPO antibody and the development of pulmonary arterial hypertension in newly detected Grave’s disease patients.

 
Close