| CTRI Number |
CTRI/2024/03/063822 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pulmonary Hypertension in Connective Tissue Disorders |
|
Scientific Title of Study
|
A Study Of Association of Pulmonary Hypertension in Connective Tissue Disorders |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Rao |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8618987924 |
| Fax |
|
| Email |
aditibmrao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Bhat |
| Designation |
Professor and Head of Unit |
| Affiliation |
Department of General Medicine, Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945272251 |
| Fax |
|
| Email |
ram.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Rao |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8618987924 |
| Fax |
|
| Email |
aditibmrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital, Manipal, Udupi 576104 |
|
|
Primary Sponsor
|
| Name |
Aditi Rao |
| Address |
Junior Resident, Department of General Medicine, Kasturba Medical college Manipal, Udupi, 576102 |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Aditi Rao |
Kasturba Hospital Manipal |
Department of General Medicine and Department of Nephrology
Udupi
KARNATAKA |
8618987924
aditibmrao@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-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M349||Systemic sclerosis, unspecified, (2) ICD-10 Condition: M341||CR(E)ST syndrome, (3) ICD-10 Condition: M342||Systemic sclerosis induced by drugand chemical, (4) ICD-10 Condition: M348||Other forms of systemic sclerosis, (5) ICD-10 Condition: M340||Progressive systemic sclerosis, (6) ICD-10 Condition: M056||Rheumatoid arthritis with involvement of other organs and systems, (7) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, (8) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified, (9) ICD-10 Condition: M321||Systemic lupus erythematosus withorgan or system involvement, (10) ICD-10 Condition: M332||Polymyositis, (11) ICD-10 Condition: M339||Dermatopolymyositis, unspecified, (12) ICD-10 Condition: M331||Other dermatomyositis, (13) ICD-10 Condition: M350||Sicca syndrome [Sjogren], (14) ICD-10 Condition: M351||Other overlap syndromes, (15) ICD-10 Condition: M358||Other specified systemic involvement of connective tissue, (16) ICD-10 Condition: M352||Behcets disease, (17) ICD-10 Condition: I270||Primary pulmonary hypertension, (18) ICD-10 Condition: I272||Other secondary pulmonary hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with connective tissue disorders- systemic sclerosis, systemic lupus erythematosus, rheumatoid arthritis, sjogrens disease, dermatomyositis, polymyositis, mixed connective tissue disorder, undifferentaited connective tissue disorder, behcets disease |
|
| ExclusionCriteria |
| Details |
Left Heart disease due to valvular heart disease, congenital heart disease , Chronic lung disease or hypoxia due to chronic obstructive pulmonary disease and sleep disordered breathing, Chronic pulmonary thromboembolism , chronic hemolytic anemia , myeloproliferative disorders, Systemic and metabolic disorders like glycogen storage disease, Gaucher disease, pulmonary Langerhans cell histiocytosis, lymphangioleiomyomatosis, and neurofibromatosis, fibrosing mediastinitis, Portal hypertension, retro viral disease, schistosomiasis or 2D echocardiogram unavailable any time within in the study period. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimate the frequency of pulmonary hypertension in patients with connective tissue disorder |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study the potential clinical and laboratory risk factors for pulmonary hypertension in patients with connective tissue disorder |
1 year |
| Compare the severity of pulmonary hypertension with the duration of the connective tissue disorder |
1 year |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
Final Enrollment numbers achieved (Total)= "77"
Final Enrollment numbers achieved (India)="77" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
16/03/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a prospective observational study at a tertiary care center recruiting the outpatients and inpatients with one of the connective tissue disorders for a study duration of 1 year . After obtaining due permission and clearance from the departments involved, the patients meeting the inclusion criteria, after ruling out the exclusion criteria will be recruited in the study after obtaining their informed consent. The clinical and laboratory data including presenting complaints, relevant examination findings, blood investigation reports along with 2D transthoracic echocardiography findings and additional imaging findings as applicable will be tabulated in a predesigned proforma. The findings of echocardiography, if done as a standard of care routinely, are noted to look for pulmonary hypertension and its severity. In case a recruited participant has multiple visits during the study period, relevant additional details like disease progression and new findings in repeat echocardiography will be noted. Since this is an observational study, there will be no interventions involved. |