Understanding How Heart Failure Affects Patients’ Physical and Emotional Well-Being in Daily Life

Not yet recruiting

Conditions: Combined systolic (congestive) anddiastolic (congestive) heart failure,

Registration Number: CTRI/2025/03/083735

Lead Sponsor: Vineetha Vijaykumar Pooojary

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 233

Inclusion Criteria

Patients aged 18 years and above with a confirmed diagnosis of CHF.
Patients who are either receiving care as outpatients or inpatients in the cardiology department.
Patients who can understand and respond in the language provided.
Patients who have provided informed consent to participate in the study.

Exclusion Criteria

•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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Kasturba Hospital
🇮🇳
Udupi, KARNATAKA, India
Kasturba Hospital
🇮🇳Udupi, KARNATAKA, India
Dr Rajesh Kamath
Principal investigator
07760218342
rajesh.kamath@manipal.edu