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CTRI Number  CTRI/2020/03/023681 [Registered on: 02/03/2020] Trial Registered Prospectively
Last Modified On: 29/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   The effect on the heart and blood vessels of thyroid hormone dysfunction 
Scientific Title of Study   CARDIOVASCULAR MANIFESTATIONS IN PATIENTS WITH THYROID DYSFUNCTION 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lalit Kummetha 
Designation  Postgraduate Doctor 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg, New Delhi 110002 INDIA

New Delhi
DELHI
110002
India 
Phone  7702488519  
Fax    
Email  lalithkummetha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naresh Kumar 
Designation  Professor 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg, New Delhi 110002 INDIA

New Delhi
DELHI
110002
India 
Phone  8076215220  
Fax    
Email  drnareshmamc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Lalit Kummetha 
Designation  Postgraduate Doctor 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg, New Delhi 110002 INDIA

New Delhi
DELHI
110002
India 
Phone  7702488519  
Fax    
Email  lalithkummetha@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg, New Delhi 110002 INDIA 
 
Primary Sponsor  
Name  MAULANA AZAD MEDICAL COLLEGE 
Address  Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg, New Delhi 110002 INDIA 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Manju Subberwal  Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg, New Delhi 110002 INDIA 
Dr Naresh Kumar  Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg, New Delhi 110002 INDIA 
Dr Sandeep Garg  Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg, New Delhi 110002 INDIA 
Dr Vimal Mehta  Maulana Azad Medical College and associated Lok Nayak Hospital and GIPMER, Bahadur Shah Zafar Marg, New Delhi 110002 INDIA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Lalit Chandra Kummetha  Lok Nayak Hospital  Medicine and endocrinology Department, Lok Nayak and GIPMER Hospital, Delhi, India
New Delhi
DELHI 
7702488519

lalithkummetha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, MAULANA AZAD MEDICAL COLLEGE & ASSOCIATED LOK NAYAK, GOVINDBALLAB PANT HOSPITAL, GURU NANAK EYE CENTRE, NEW DELHI-110002  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E07||Disorders of thyroid gland,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients falling into the categories of hyperthyroidism, subclinical hypothyroidism and hypothyroidism 
 
ExclusionCriteria 
Details  1. Known case of Diabetes Mellitus
2. Known case of Coronary Artery Disease, COPD (Previously diagnosed), Chronic Kidney Disease(Previously diagnosed), and Chronic Liver Disease(Previously diagnosed)
3. Pateints taking drugs which affect thyroid function
4. Pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the prevalence of cardiovascular manifestations in patients of thyroid dysfunction  Less than or equal to One year 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effect of treatment on the metabolic profile in patients with thyroid disorders  Less than or equal to One year 
To study the effect of treatment on NT ProBNP Levels in pateints with thyroid disorders   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)   02/03/2020 
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)?  

Brief Summary  

 

 

Purpose of the trial :- To study various cardiovascular manifestations in patients with thyroid dysfunction.

 

Objectives:

 

PRIMARY OBJECTIVES:

 

•       To study the prevalence of cardiovascular manifestations in patients of thyroid dysfunction

 

•       To study the effect of treatment on the cardiovascular manifestations in these patients

 

SECONDARY OBJECTIVES:

 

•       To study the effect of treatment on metabolic profile in patients with thyroid disorders

 

•       To study the effect of treatment on NT Pro BNP levels in patients with thyroid disorders

 

Some major findings and references:

 

1. In a study conducted by M.Schultz et al,  NT-pro-BNP levels were more than four times higher in hyperthyroid than hypothyroid patients, with mean values of 30 and 7 pmol/l, respectively ( P < 0·001). Serum NT-pro-BNP levels correlated to the thyroid function ( vs. free T4 estimate: r = 0·52, P < 0·0001, n = 57). Treatment resulted in significant increases in NT-pro- BNP in both hypothyroid groups, and decreases in both hyperthyroid groups.

 

2. Regarding hyperthyroidism, in one study conducted by Hailu Abera Mulatu, Echocardiographic abnormalities were detected in half (50.7%) of the patients. The study showed that (18.5%) patients had heart failure at initial presentation with the most common cardiovascular manifestations being exertional dyspnea (54.8%), pitting edema (18.5%) and elevated jugular venous pressure (15.8%). Nearly half (48.6%) of the patients had hypertension, and atrial fibrillation was seen in 11% of patients.(4.1%) patients had heart failure with reduced ejection fraction while another (4.1%) patients had isolated right sided heart failure. Pulmonary hypertension with pulmonary artery systolic pressure of 35 mmHg or more was found in (37%) patients.

 

3. Regarding hypothyroidism, in a study by Preshant Shrivastava, more than 65% subjects were found to have clinically significant cardiovascular changes. ECG changes observed were Sinus bradycardia in 35.5%, Low voltage complexes in 16.6%, T Wave inversion in 7.8%, RBBB in 4.4%, and QTc prolongation in 2.2% cases. About 64% cases had changes as observed in echocardiographic examination. Most common finding was Diastolic dysfunction seen in 20% cases. This was followed by Pericardial Effusion and Increased IVSD thickness in 16.6% cases each. Increased LVPW thickness was seen in 11.1% cases.


 
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