| CTRI Number |
CTRI/2024/03/064245 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal Study |
| Study Design |
Other |
|
Public Title of Study
|
Heart function assessment in atrial fibrillation patients |
|
Scientific Title of Study
|
Effect of rate control and rhythm control therapy on left atrial function in atrial fibrillation patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja |
| Designation |
Post graduate student |
| Affiliation |
Manipal college of health professions |
| Address |
Room Number: 212, 2nd floor, Department of CVT, MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8431792763 |
| Fax |
|
| Email |
16nayakpooja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mukund A Prabhu |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical college, Manipal |
| Address |
Department of Cardiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9895137146 |
| Fax |
|
| Email |
mukundaprabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukund A Prabhu |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical college, Manipal |
| Address |
Department of Cardiology, Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9895137146 |
| Fax |
|
| Email |
mukundaprabhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology, Kasturba Medical College, Manipal Academy of higher education |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Manipal Academy of Higher education, Manipal |
| Address |
Kasturba Medical College and Hospital, Tiger circle road, Madhava Nagar, Manipal Udupi, Karnataka, PIN -576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mukund A Prabhu |
Kasturba Hospital Manipal |
Room No:34, Echocardiography room, 3rd floor new OPD block, Kasturba Medical College, Manipal Academy of Higher education
Udupi
KARNATAKA |
9895137146
mukundaprabhu@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I481||Persistent atrial fibrillation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age group more than 18 years, diagnosed with persistent AF planned for management or already on
management but didn’t achieve the goal of any gender, LVEF more than or equal to 50%
|
|
| ExclusionCriteria |
| Details |
Congenital heart disease, Valvular heart disease, Miscellaneous heart disease, LV diastolic dysfunction more than Grade II |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
LA expansion index (%)
LA volume index (mL/m2)
LA Function index
LA emptying fraction (%)
HR (bpm)
Rhythm |
At the recruitment
At one month
At six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="113"
Sample Size from India="113"
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)
|
25/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study will be conducted after obtaining IRC and IEC approval and CTRI registration. After IRC and IEC approval and CTRI registration the patients with persistent AF visiting to the hospital after meeting inclusion criteria will be recruited in the study. The study will be explained, and consent will be taken. Standard view: PLAX, PSAX at 3 levels of LV, Apical 4C,2C,3C will be recorded at baseline. After 1 month PLAX, PSAX at 3 levels of LV, Apical 4C,2C,3C will be recorded as a part of routine evaluation. Effectiveness of rate and rhythm control therapy will be assessed based on baseline and 1 month follow up data. After 6 months PLAX, PSAX at 3 levels of LV, Apical 4C,2C,3C will be recorded as a part of routine evaluation. At this stage comparison is made between those who achieve rate control or rhythm control. Then offline analysis will be done using ECHOPAC. |