A study to understand Effectiveness and safety of CIDMUS tablets in Heart Failure with reduced and Mid-range ejection fraction patients
Not Applicable
- Conditions
- Health Condition 1: I502- Systolic (congestive) heart failure
- Registration Number
- CTRI/2024/03/064528
- Lead Sponsor
- Dr. Reddy’s Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Male or female patients of Age greater or equal to 18 years
2.Patients diagnosed with Heart Failure with Ejection fraction lessthan 50% at baseline, who were prescribed CIDMUS for the first time or within one week.
3.Patients willing to provide consent to participate in the study
Exclusion Criteria
1. Contraindications to the study drug as per physician’s discretion.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Ejection Fraction from baseline visit to follow-up visits 1,3,6, and 12 months in Heart failure patients on CIDMUS as per below sub groupsTimepoint: 1,3,6 and 12 months
- Secondary Outcome Measures
Name Time Method 1. Safety assessment - Frequency and severity of AEs <br/ ><br>2.Emergency visits due to HF requiring inotropic agents/iv diuretics at 1, 3,6, and 12 months <br/ ><br>3.Incidence of hospitalization in HFrEF and HFmrEF patients on CIDMUS at 1,3,6, and 12 months <br/ ><br>4.Incidence of cardiac death in HFrEF and HFmrEF patients on CIDMUS at 1,3,6, and 12 months <br/ ><br>5.Change in NT-proBNP from baseline visit to follow-up visits 1,3,6, and 12 months in HFrEF and HFmrEF patients on CIDMUS <br/ ><br>6. Change in NYHA class from baseline to 1,3,6, and 12 months in HFrEF and HFmrEF patients on CIDMUS <br/ ><br>7.Average dose of the drug prescribed & compliance to therapyTimepoint: 1,3,6, and 12 months