| CTRI Number |
CTRI/2023/10/058641 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prospective Heart Failure Registry - heart failure is a condition where there is reduction in the pumping efficiency of the heart - the study tests the presentation, treatment and outcomes of this disease |
|
Scientific Title of Study
|
Prospective Heart Failure Registry |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabhakar Dorairaj |
| Designation |
Cardiologist |
| Affiliation |
Ashwin Clinic, Chennai |
| Address |
Consultation Room 1,
AG 25,
IV Avenue, Annanagar,
Chennai
India
Chennai
TAMIL NADU
600040
India |
| Phone |
9884012727 |
| Fax |
|
| Email |
acertcardio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prabhakar Dorairaj |
| Designation |
Cardiologist |
| Affiliation |
Ashwin Clinic, Chennai |
| Address |
Consultation Room 1,
AG 25,
IV Avenue, Annanagar,
Chennai
India
Chennai
TAMIL NADU
600040
India |
| Phone |
9884012727 |
| Fax |
|
| Email |
acertcardio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prabhakar Dorairaj |
| Designation |
Cardiologist |
| Affiliation |
Ashwin Clinic, Chennai |
| Address |
Consultation Room 1,
AG 25,
IV Avenue, Annanagar,
Chennai
India
Chennai
TAMIL NADU
600040
India |
| Phone |
9884012727 |
| Fax |
|
| Email |
acertcardio@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACERT is a research group of Cardiologists - Associates of Cardiology Education and Research |
|
|
Primary Sponsor
|
| Name |
Associates for Cardiology Education and Research in TamilnaduACERT |
| Address |
AG -25, IV Avenue
Annanagar, Chennai
India - 600040 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prabhakar Dorairaj |
Apollo First Med Hospital |
Room No 1014, Basement,
154, PH Road,
Kilpauk, Chennai
600010
Chennai
TAMIL NADU |
9884012727
prabhud19@gmail.com |
| DrDPrabhakarMDDM |
Billroth hospitals |
Consultation Room M,
Department of Cardiology,
43, Lakshmi Talkies Road
Shenoy Nagar
Chennai
TAMIL NADU |
9884012727
prabhud19@gmail.com |
| Dr Shanmugasundaram |
GKNM Hospital |
Cardiology Deparment
GKNM Hospital
Netaji Rd, Pappanaickenpalayam, Coimbatore, Tamil Nadu 641037
Coimbatore
TAMIL NADU |
9865633308
shanmugasundaram@gknmgh.org |
| DrB Karthikeyan |
Hindu Mission Hospital |
Room No 1, Department of Cardiology,
103 GST Road, West Tambaram,
Chennai - 600045
Chennai
TAMIL NADU |
9894169098
b_karthikeyan@yahoo.com |
| Dr Ajit Mullasari S |
MADRAS MEDICAL MISSION |
Consultation Room 4, L Floor,
4A- DR.JJ NAGAR,
MOGAPAIR,
CHENNAI - 600037
Chennai
TAMIL NADU |
9841271361
sulu_ajit57@yahoo.co.in |
| Dr Kesavamoorthy |
Meenakshi Hospital |
R No 1,
Department of Cardiology,
244/2 Trichy Main Road
Thanjavur - 613005
Chennai
TAMIL NADU |
9845033681
drbkesav@gmail.com |
| DrSamaAkber |
Oxymed Hospital and Research Institute |
14/1, Second Street, III Main Road,
Nandanam, Chennai - 600035
Chennai
TAMIL NADU |
9940259890
dr.samaakber@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Billrothhospitals |
Approved |
| Hindu Mission Hospital |
Approved |
| Institutional Ethics Committee - Bio Medical Research, Apollo Hospitals, Chennai |
Approved |
| Institutional Ethics Committee GKNM Hospital |
Approved |
| Meenakshi Hospital |
Approved |
| Oxymed Ethics Committee |
Approved |
| The Madras Medical Mission |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I429||Cardiomyopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
NIl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Heart Failure with LVEF < 50%
2. Age > 18 years
3. Atleast two months follow up in the center(or)
4. Atleast second visit following acute heart failure hospitalization.
|
|
| ExclusionCriteria |
| Details |
1. Refusal to consent
2. Failure to adhere to therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Death
Hospitalization for heart failure
Non-fatal Myocardial infarction
Stroke
New onset atrial fibrillation
Assessment of the progression of the disease
|
3 months
6 months
1 year, 2 years, 3 years, 4 years, 5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Interventions for Heart Failure
Treatment patterns
Drug utilization |
3 months
6 months
1 year, 2 years, 3 years, 4 years, 5 years |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
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)
|
23/10/2023 |
| 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="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Chronic Heart Failure Registry is a prospective follow up study of outpatients in Heart Failure with reduced Ejection Fraction (HFrEF) with a Left ventricular Ejection fraction of < 50%. Aimf Aim of the study: To determine the etiology and management strategies in chronic heart failure. To determine the five year outcome in Chronic heart failure What What is Unique in this registry? First outpatient registry of heart failure in India following the withdrawal of patent of the four pillars in the management of heart failure - betablockers, ARNI drugs, Mineralocorticoid receptor antagonists, and SGLT2 inhibitors.
|