| 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E07||Disorders of thyroid gland, |
|
|
Intervention / Comparator Agent
|
|
|
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. |