Health Condition 1: N189- Chronic kidney disease, unspecified Health Condition 2: I501- Left ventricular failure, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of age 18 year to 80 year and of either sex. 2. Patients of Heart failure with reduced ejection fraction. 3. Patients with eGFR less than 90 ml per min per 1.73 m2 at screening.
Exclusion criteria
Exclusion criteria: 1. Patients who are already on any of the first-line heart failure drugs for other indications. 2. Patients with preserved ejection fraction. 3. Patients with raised AST/ALT more than 3 times from baseline. 4. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in eGFR levels from baseline to 16 weeks.Timepoint: baseline, 16 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in eGFR levels from baseline to 16 weeks based on type of therapeutic intervention. 2. Mean change in eGFR levels from baseline to 16 weeks based on chronic kidney disease (CKD) stages. 3. Corelation between mean change in eGFR with NT-pro BNP and GDF-15 levels from baseline to 16 weeks among HFrEF and CKD patients having diabetes. 4. Cost effectiveness analysis of first line drug therapy used in HErEF with CKD patients over 16 weeks. 5. Safety profile of first line drug therapy used in HErEF with CKD patients over 16 weeks. 6. Change in Health status from baseline to 16 weeks based on KCCQ-OSS Score.Timepoint: baseline, 16th week | — |
Countries
India
Contacts
All India Institute Of Medical Sciences, Jodhpur