| CTRI Number |
CTRI/2025/10/096525 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on How Heart Failure Affects the Quality of Life in Women |
|
Scientific Title of Study
|
Assessment of Quality of Life in Women with Heart Failure: A Cross-Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nair Amrita Radhakrishnan |
| Designation |
Post graduate student |
| Affiliation |
M S Ramaiah College of Physiotherapy |
| Address |
M S Ramaiah College of Physiotherapy,
Ramaiah University of Applied Sciences,
M.S.R.I.T Post, Bengaluru-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
7738566729 |
| Fax |
|
| Email |
arnair256@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shaswat Verma |
| Designation |
Associate Professor |
| Affiliation |
M S Ramaiah College of Physiotherapy |
| Address |
M S Ramaiah College of Physiotherapy,
Ramaiah University of Applied Sciences,
M.S.R.I.T Post, Bengaluru-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9886591748 |
| Fax |
|
| Email |
shaswatverma.rcp@msruas.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nair Amrita Radhakrishnan |
| Designation |
Post graduate student |
| Affiliation |
M S Ramaiah College of Physiotherapy |
| Address |
M S Ramaiah College of Physiotherapy,
Ramaiah University of Applied Sciences,
M.S.R.I.T Post, Bengaluru-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
7738566729 |
| Fax |
|
| Email |
arnair256@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.S Ramaiah Medical College Hospital, Bengaluru and M.S Ramaiah Memorial Hospital, Bengaluru
MSR Nagar, MSRIT Post, Bengaluru 560054 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Veena Kiran Nambiar |
Ramaiah Hospitals, Bengaluru |
Room no: 20
Cardiology OPD
Superspeciality Block
Bangalore
KARNATAKA |
9880575407
veenakn.rcp@msruas.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramaiah Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Women clinically diagnosed with Heart Failure
Age: 40 years and above
Clinically stable
Able to read and understand English and Kannada
|
|
| ExclusionCriteria |
| Details |
Cognitive impairment or psychiatric disorders
NYHA Class IV
Severe comorbid conditions like advanced cancer, end-stage renal disease
Women with heart failure as a secondary diagnosis to other primary systemic conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check quality of life in women with heart failure by using India Heart Failure specific Quality of Life (IHFQoL) questionnaire |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="263"
Sample Size from India="263"
Final Enrollment numbers achieved (Total)= "263"
Final Enrollment numbers achieved (India)="263" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
31/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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)
|
Ethical clearance was obtained from Ramaiah Medical College Ethics Committee. The India Heart Failure Quality of Life (IHFQoL) questionnaire was translated and validated in Kannada language. 263 women diagnosed with heart failure were screened and recruited based on inclusion and exclusion criteria. The participants were explained the need of the study, and informed consent was obtained. Assessment of quality of life in women with heart failure was done by administering India Heart Failure Quality of Life (IHFQoL) questionnaire respectively. |