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CTRI Number  CTRI/2025/11/097891 [Registered on: 21/11/2025] Trial Registered Prospectively
Last Modified On: 21/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective cohort study 
Study Design  Single Arm Study 
Public Title of Study   Long Term Cardiac Health Effects In Pulmonary TB 
Scientific Title of Study   Long Term Cardiac And Pulmonary Consequences Of TB (LONG TB) 
Trial Acronym  LONG TB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Devasahayam J Christopher 
Designation  Sr. Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Pulmonary Medicine (Ranipet Campus)
Christian Medical College, Vellore (Ranipet Campus)
Vellore
TAMIL NADU
632517
India 
Phone  09443306573  
Fax    
Email  djchris@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Devasahayam J Christopher 
Designation  Sr. Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Pulmonary Medicine (Ranipet Campus)
Christian Medical College, Vellore (Ranipet Campus)
Vellore
TAMIL NADU
632517
India 
Phone  09443306573  
Fax    
Email  djchris@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Devasahayam J Christopher 
Designation  Sr. Professor 
Affiliation  Christian Medical College, Vellore 
Address  Department of Pulmonary Medicine (Ranipet Campus)
Christian Medical College, Vellore (Ranipet Campus)
Vellore
TAMIL NADU
632517
India 
Phone  09443306573  
Fax    
Email  djchris@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
National Institutes of Health (NIH) and CRDF Global 9000 Rockville Pike Bethesda, Maryland 20892 
 
Primary Sponsor  
Name  National Institutes of Health NIH  
Address  9000 Rockville Pike, Bethesda, Maryland, 20892, United States  
Type of Sponsor  Other [US Funding agency] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Philippines
South Africa
Uganda  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Haridas Prasad  Byramjee Jeejeebhoy Government Medical College  Sasoon Road, Pune, Maharashtra, 411001
Pune
MAHARASHTRA 		 9422308155

ayush.prasad@rediffmail.com 
Devasahayam J Christopher  Christian Medical College   Room: 29, A block, Department of Pulmonary Medicine Christian Medical College, Vellore (Ranipet Campus)
Vellore
TAMIL NADU 		 09443306573

djchris@cmcvellore.ac.in 
Dr Sonali Sarkar  Jawaharlal Institute of Postgraduate Medical Education and Research  JIPMER, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006.
Pondicherry
PONDICHERRY 		 9442174663

sarkarsonaligh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee- BJ Medical College and Sassoon General Hospitals   Approved 
Institutional Ethics Committee for Observational Studies  Approved 
Institutional Review Board, Office of Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J984||Other disorders of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1 Adults more thab 18 years of age
2 Xpert Ultra PTB -MTB detected and subsequently confirmed by MTB culture

3 Ability and willingness to provide informed consent, including consent for blood and sputum collection and storage for future research
 
 
ExclusionCriteria 
Details  1 More than 7 days of TB treatment for current TB episode
2 Prior history of TB, regardless of treatment duration
3 Multi- or extensively-drug resistant pulmonary TB, or poly-resistant pulmonary TB
4 Extra-pulmonary TB without microbiologically confirmed pulmonary involvement
5 Prior physician diagnosis of any chronic lung disease or cardiovascular disease
6 Pregnant women or those who plan to get pregnant during the study period
7 Severe illness which, in the study clinician’s judgement, will interfere with the participants ability to complete all study visits
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcomes will focus on persistent PTLD and sub-clinical CVD, with secondary outcomes including changes in lung function and cardiovascular parameters. This study aims to fill critical knowledge gaps and establish a valuable resource for future research on post-TB sequelae.  0 week, 6 months and 12months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes will include changes in lung function, 6 min walk distance, respiratory questionnaire scores, & quantitative imaging parameters. For Aim 2, the primary outcome will be persistent sub-clinical CVD, identified through various cardiovascular assessments. Secondary outcomes will include changes in ejection fraction, carotid intima-media thickness, & pulmonary artery systolic pressure.  0 week, 6 months & 12months 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="150" 
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)   01/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/02/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response (Others) -  Approvals
  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [djchris@cmcvellore.ac.in].

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 18-02-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Tuberculosis (TB) survivors often face health problems even after they are cured, such as lung and heart issues. This study aims to find out why some people develop these problems and others don’t, which will help doctors better predict and treat these conditions.

 

The study will follow 350 adults who have been newly diagnosed with TB and do not have any previous lung or heart diseases. These patients will be from various hospitals in India, South Africa, the Philippines, and Uganda. They will be monitored for one year after starting TB treatment. Participants will undergo various health tests to check their lung and heart functions. These tests will include breathing tests, walking tests, questionnaires about their respiratory health, and imaging tests like X-rays and scans. Blood samples will be taken to check for markers related to diabetes, inflammation, heart stress, and cholesterol levels. Sputum and blood samples will be stored for future research. The study aims to identify persistent lung and heart problems at the end of TB treatment and six months later. This research will help fill important gaps in our understanding of the long-term health effects of TB and provide valuable samples for future studies.

 

 
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