| CTRI Number |
CTRI/2020/06/025735 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
29/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
CLEAR FIBROSIS HEART TRAIL |
|
Scientific Title of Study
|
Perfenidone in Endomyocardial Fibrosis patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Walia |
| Designation |
Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic |
| Affiliation |
All India Institute of Medical Science , Rishikesh |
| Address |
Room Number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh , Uttarakhand.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Walia |
| Designation |
Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic |
| Affiliation |
All India Institute of Medical Science , Rishikesh |
| Address |
Room Number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh , Uttarakhand.
UTTARANCHAL
249203
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Walia |
| Designation |
Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic |
| Affiliation |
All India Institute of Medical Science , Rishikesh |
| Address |
Room Number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh , Uttarakhand.
UTTARANCHAL
249203
India |
| Phone |
8800492549 |
| Fax |
|
| Email |
rwalia7731@yahoo.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science , Rishikesh |
|
|
Primary Sponsor
|
| Name |
Rohit Walia |
| Address |
Room Number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh |
| 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 |
| Rohit Walia |
All India Institute of Medical Science Rishikesh |
Room number 25103, Department of Cardiology , All India Institute of Medical Science , Virbhadra Road , Pashulok , Rishikesh
Dehradun
UTTARANCHAL |
8800492549
rwalia7731@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Perfenidone Drug |
Start with 200 mg TDS orally , if tolerated after one week increase to 400 mg TDS and if tolerated increase to 600 mg TDS orally |
| Comparator Agent |
Placebo |
Placebo |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Endomyocardial Fibrosis patients
Informed consent |
|
| ExclusionCriteria |
| Details |
Chronic Renal Failure
Liver Failure
Expected life expectancy less than one year
Associated Malignancy
Assisted circulation
Cardiac devices
Contraindications to MRI
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in myocardial extracellular volume |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Absolute change in LV and RV mass, volume, ejection fraction, myocardial cell volume, LV diastolic function, strain, backscatter and backscatter and torsion
Absolute change in left atrium and right atrium volume and function and left atrial function , Absolute change in NT pro BNP and HS- Troponin T ,Absolute change in exercise tolerance
All-cause mortality, cardiovascular mortality, hospitalisations due to heart failure and arrhythmias will be recorded
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
30/06/2020 |
| 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="2"
Months="6"
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
|
Endomyocardial Fibroisis is a disease with no curative treatment or drug to limit fibrosis progression . Perfenidone is an anti fibrotic drug which is approved for treatment of idiopathic pulmonary fibrosis which is also characterised by diffuse severe fibrosis of lungs. Perfenidone has shown good results in randomised controlled trails for this condition . We plan to test perfenidone for end-myocardial fibrosis patients and use cardiac MRI to evaluate its effect on the progression of disease over one year. |