Study on Heart Failure patients
- Conditions
- Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure
- Registration Number
- CTRI/2021/04/032844
- Lead Sponsor
- MEDANTA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients meeting with following criteria to be included in the study:
1) Adult patients (but not younger than18 year old) will be included
2) Completion of written informed consent before any assessment is performed.
3) Patients who will be admitted to the hospital or emergency department with a (newly or with existing) diagnosis of heart failure with HFrEF and HFmEF
Patients meeting with following criteria to be excluded from the study:
1) Currently enrolled in another interventional study
2) The patient has recently completed a clinical trial (within past 3 months) that has been terminated and other options (e.g., trial extensions, amendments, etc.) are available to continue a similar treatment, similar tools.
3) Severe cognitive dysfunction or dementia
4) Pregnant or lactating Women.
5) Patients and/or his/her legally acceptable representative not willing to provide voluntary written informed consent for participation in the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the quality of life in heart failure patients using 36 Item Short Form Health Survey (SF-36)Timepoint: 0 month and 3 month
- Secondary Outcome Measures
Name Time Method 1) To assess the quality of life in heart failure patients using WHOQOL â?? BREF <br/ ><br>2) To assess the patient quality of life using EQ-5D-3L questionnaire <br/ ><br>3) To estimate the frequency of non-achievement of Guideline-Directed Medical Therapy (GDMT) in real world scenario and evaluate the reasons therein. <br/ ><br>4) To evaluate heart rate during admissions and on subsequent follow up <br/ ><br>5) To estimate the rate of re-hospitalisation and LVEF <br/ ><br>6) Adverse events (AE) or serious adverse events (SAE)Timepoint: 0 month and 3 month