Health Condition 1: I502- Systolic (congestive) heart failure
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosis of HFrEF as per ACC/ AHA 2022 with NYHA class II-III heart failure symptoms. 2. HFrEF patients newly initiated on SGLT-2 inhibitor. 3. Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines with both drugs and devices, as appropriate. 4. Patient willing to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Any kind of severe comorbities, which delimits the patient from giving consent and participation in the study. 2. Any previous history of allergy with SGLT2 inhibitor. 3. Type 1 diabetes mellitus (T1DM). 4. Symptomatic hypotension or systolic BP less than 95 mmHg on 2 consecutive measurements. 5. Severe (eGFR less than 30mL/min/1.73 m2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of screening. 6. Pregnant, Lactating mother and women of child-bearing potential (who are not willing to use a medically accepted method of contraception).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare changes in patient-reported outcomes using Kansas City Cardiomyopathy Questionnaire (KCCQ) between genders.Timepoint: 0,3,6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the efficacy SGLT2 inhibitors in reducing HF-related hospitalizations and 3 point MACE (Cardiovascular death, Non-fatal MI, and Non-fatal stroke) between male and female patients. 2. To assess gender-specific changes from baseline in key clinical, biochemical, and functional parameters. 3. To assess adverse effect profile stratified by gender.Timepoint: 0,3 6 month | — |
Countries
India
Contacts
Public ContactDr. Aarthikaa R
PGIMER
Outcome results
None listed