| CTRI Number |
CTRI/2025/03/083735 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding How Heart Failure Affects Patients’ Physical and Emotional Well-Being in Daily Life |
|
Scientific Title of Study
|
Assessment of Physical and Emotional Health-Related Quality of Life among Congestive Heart Failure Patients with Preserved and Reduced Ejection Fraction at a Tertiary Care Teaching Hospital in Coastal Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vineetha Vijaykumar Poojary |
| Designation |
Postgraduate Student |
| Affiliation |
Prasanna School of Public Health, MAHE, Manipal |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education,
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7349220265 |
| Fax |
|
| Email |
vineetha.psphmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Kamath |
| Designation |
Assistant Professor - Senior Scale |
| Affiliation |
Prasanna School of Public Health, MAHE, Manipal |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education,
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7760218342 |
| Fax |
|
| Email |
rajesh.kamath@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Kamath |
| Designation |
Assistant Professor - Senior Scale |
| Affiliation |
Prasanna School of Public Health, MAHE, Manipal |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
07760218342 |
| Fax |
|
| Email |
rajesh.kamath@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi Taluk and Distict-576104, Karnataka, India.
|
| Department of Cardiology, Kasturba Hospital, Manipal, Udupi Taluk and District-576104, Karnataka, India.
|
|
|
Primary Sponsor
|
| Name |
Vineetha Vijaykumar Pooojary |
| Address |
Department of Social and Health Innovation, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal, Udupi Taluk and District-576104, Karnataka, India. |
| 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 |
| Dr Rajesh Kamath |
Kasturba Hospital |
Department of Cardiology, 3rd Floor, Division- Unit 1 and Unit 2, Manipal.
Udupi
KARNATAKA |
07760218342
rajesh.kamath@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I504||Combined systolic (congestive) anddiastolic (congestive) heart failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years and above with a confirmed diagnosis of CHF.
2. Patients who are either receiving care as outpatients or inpatients in the cardiology department.
3. Patients will be classified within NYHA functional classes I to IV.
4. Patients who can understand and respond in the language provided.
5. Patients who have provided informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
•Patients below 18 years of age.
•Patients with communication impairments that prevent them from understanding or responding to the questionnaire.
•Patients with cognitive disorders that affect their ability to participate in the study. •Patients unwilling to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study will be the HRQoL of CHF patients, which will be measured using the MLHFQ Questionnaire. The total MLHFQ score and the domain-specific scores (physical and emotional) will be assessed, with higher scores indicating poorer quality of life. The Differences in HRQoL between patients with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) will be compared. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes will include the correlation of HRQoL with clinical & demographic factors. These outcomes will provide insights into the impact of ejection fraction & other factors on the overall well being of CHF patients. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="233"
Sample Size from India="233"
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)
|
12/04/2025 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Aim and objectives:
Aim: To assess and compare the physical and emotional health-related quality of life (HRQoL) among congestive heart failure (CHF) patients with preserved and reduced ejection fraction
Objectives: 1. To evaluate the HRQoL of CHF patients with preserved and reduced ejection fraction using a standardized questionnaire. 2.To compare the HRQoL between CHF patients with preserved ejection fraction (HFrEF) and those with reduced ejection fraction (HFrEF). 3.To identify the sociodemographic factors that affect HRQoL in CHF patients.
Study Materials:
A standardized questionnaire, ie., the Minnesota Living with Health Failure Questionnaire (MLHFQ) for assessing health-related quality of life (HRQoL) among CHF patients, will be used. A validated demographic and medical data collection form will be used to collect participant details, including age, gender, New York Heart Association (NYHA) functional class, duration of CHF, and ejection fraction percentage. An informed consent form (icf) and participant information sheet (PIS) will be provided to ensure ethical compliance and voluntary participation. Author permission has been obtained for the use of the MLHFQ questionnaire.
Study Procedure:
Patients from the Cardiology Department at Kasturba Hospital, Manipal will be initially screened, and eligible cases will be selected based on the inclusion and exclusion criteria. Written informed consent will be obtained from all participants. Patient data, including demographic and clinical characteristics, will be collected using a structured questionnaire.
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) will be used to assess health-related quality of life (HRQoL) among CHF patients. Participants will be categorized into two groups: HFpEF ( Preserved Ejection Fraction, LVEF greater than or equal to 50% ) HFrEF( Reduced Ejection Fraction, LVEF less than or equal to 40% )
Statistical analysis will be conducted to compare HRQoL scores between HFrEF and HFpEF patients. The relationships between sociodemographic factors, clinical characteristics, and HRQoL will also be analyzed. The results will help in understanding the impact of CHF on patients’ physical and emotional well-being and provide insights to improve patient care.
Statistical methods:
Descriptive statistics will be used to describe participant demographics and clinical characteristics. Spearman’s correlation will be used to assess relationships between sociodemographic variables, medical conditions and HRQoL. Independent t-tests will be conducted to compare HRQoL scores between HFrEF and HFpEF patients, and chi-square tests will be used to examine associations between categorial variables.
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