| CTRI Number |
CTRI/2023/08/057003 [Registered on: 28/08/2023] Trial Registered Prospectively |
| Last Modified On: |
11/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the nature of day/night clock gene Abnormalities in Cardiovascular Diseases and their effect on potency of Cardiac Medicines |
|
Scientific Title of Study
|
Understanding Circadian Abnormalities in Cardiovascular Diseases and Circadian Regulation of Cardiac Medicines |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandipan Ray |
| Designation |
Assistant professor |
| Affiliation |
IIT Hyderabad |
| Address |
Department of Biotechnology
Indian Institute of Technology Hyderabad
Kandi, Sangareddy 502285, Telangana, India
Hyderabad
TELANGANA
502285
India |
| Phone |
7439865060 |
| Fax |
|
| Email |
sandipan.ray@bt.iith.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Mohanty |
| Designation |
Consultant - Cardiology & Interventional Cardiology |
| Affiliation |
Continental Hospital |
| Address |
Plot No 3, Rd Number 2, Financial District, Gachibowli, Nanakaramguda, Telangana 500032
Hyderabad
TELANGANA
500032
India |
| Phone |
9666121115 |
| Fax |
|
| Email |
abhisekh.m@continentalhospitals.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreyayukta Chakraborty |
| Designation |
PhD scholar |
| Affiliation |
IIT Hyderabad |
| Address |
Department of Biotechnology
Indian Institute of Technology Hyderabad
Kandi, Sangareddy 502285, Telangana, India
Hyderabad
TELANGANA
502285
India |
| Phone |
9600153562 |
| Fax |
|
| Email |
bo22resch11007@iith.ac.in |
|
|
Source of Monetary or Material Support
|
| Continental Hospital,Plot No 3, Road No. 2, Financial District, Gachibowli, Nanakaramguda, Telangana 500032 |
|
|
Primary Sponsor
|
| Name |
IIT hyderabad |
| Address |
Department of Biotechnology
Indian Institute of Technology Hyderabad
Kandi, Sangareddy 502285, Telangana, India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Abhishek Mohanty |
Continental Hospitals |
Plot No 3, Rd Number 2, Financial District, Gachibowli, Nanakaramguda, Telangana 500032
Hyderabad
TELANGANA |
9666121115
abhisekh.m@continentalhospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee- continental hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteer without cadiovascular disease |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults of either gender (<40 years young group, >40 years older group) suffering from
cardiovascular diseases (a narrow age range to avoid age-related circadian variations)
2. Cardiovascular disease diagnosed based on the clinical manifestations and confirmed
through an electrocardiogram (ECG)
3. Age and gender (and occupation, if possible) matched healthy participants as control
subjects based on medical history, clinical examination, and laboratory investigations
4. Subjects (patients and controls) willing to provide written informed consent and comply
with protocol requirements |
|
| ExclusionCriteria |
| Details |
1. Subjects reluctant to provide written informed consent or to comply with the study
protocol
2. Subjects with any significant medical history (ongoing or in the recent past)
3. Currently diagnosed with a neurological or sleep disorder (narcolepsy, obstructive sleep
apnea, restless leg syndrome) and/or being prescribed a non-psychotropic medication that
can alter sleep and circadian rhythms (such as cortisone)
4. Subjects with severe anemia (Hb level < 7g/dL)
5. Female patients who are pregnant at the time of enrolment
6. Subjects who are chronic alcoholics or smokers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Altered rhythmicity of physiological and biochemical parameters in cardiovascular-diseased (CVD) patients. |
3 years 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Optimal time of the day for beta-blocker administration in CVD patients. |
3 years 6 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
17/09/2023 |
| 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="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The central hypothesis of this project is that the circadian clock plays a significant role in cardiac health, and the aberrations in clock machinery could be assessed as a risk factor for cardiovascular diseases. Our research strategy in this project will emphasize elucidating circadian regulation and abnormalities in early-stage (young) and elder CVD patients. We will investigate how diurnal rhythmicity in physiological and biochemical parameters is altered in heart disease patients. In this project, we also intend to illustrate the rhythmicity in the expression of prominent molecular targets for commonly used cardiac medicines to evaluate their possible dosing time dependency (in terms of therapeutic efficacy and side effects). |