Empagliflozin on Patients With Preserved Heart Failure

Damanhour University

Status: Completed

Conditions: Heart Failure

Treatments: Other: Placebo Tablet; Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT07112274

EMPAGLIFLOZIN on HF

Details and patient eligibility

About

The proposed research in this application will investigate the effect of empagliflozin on cardiac remodeling in patients with heart failure with preserved ejection fraction.

Full description

1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.

2. All participants should agree to take part in this clinical study and will provide informed consent.

3. About 50 cardiac non diabetic patients diagnosed with heart failure with preserved ejection fraction will be recruited from Mahalla Cardiac Centre outpatient clinics and randomize them into two groups, group on empagliflozin 10 mg once daily and the second group placebo.

4. Blood samples will be collected before, and 3 months after intiation of the trial for evaluating Complete blood count (CBC), Serum creatinine (SCr), Aspartate aminotransferase (AST), Alanine transaminase(ALT), Hemoglobin A1C and two biomarkers which are: Human N-Terminal Pro Brain Natriuretic Peptide (NT-ProBNP) and soluble suppressor of tumorigenicity 2 (sST2) values in both groups.

5. Echocardiogram will be assessed for the patients before and 3 months after the initiation of study and the values of :

   1. Left ventricular end systolic volume index (LVESI)

   2. Left atrial volume index (LAVI)

   3. Left ventricular mass index (LVMI)

   4. Ejection fraction (EF)

   5. Left atrium size

   6. Grade of diastolic dysfunction

   7. Cardiac output (C.O.P)

   8. Stroke volume (SV)

      Method:

      - All participants will be randomly divided into two groups: group (A) for empagliflozin (n=25), group (B) for placebo (n=25)

      Sample sizes of 50 cardiac patients (25 empagliflozin group and 25 placebo group), achieves 90% power to detect a difference (7.5 ml/m2) in the mean change of Left ventricular end systolic volume index (LVESI) between the 2 groups, using independent t test, at a 0.05 significance level.

      The sample size was calculated using NCSS 2004 and PASS 2000 software

      • Treatment group will receive empagliflozin 10 mg tablet once daily and control group will receive placebo tablet.
      • Cardiac biomarkers will be assessed at baseline before trial initiation and 3 months after the initiation of trial
      • SPSS will be used for statistical analysis of the data obtained in the research, measurement data using t test
      • A value of P<0.05 was considered to indicate a statistically significant difference.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inculsion

1. Cardiac patients who diagnosed with HFpEF, EF more than 50 %.
2. Patients should have basically normal liver and kidney functions, normal coagulation, and have no serious auditory, visual or central nervous system diseases.
3. Patients with no history of immune system disease.

Exclusion

1. Patients with declined baseline creatinine clearance below 60 ml/min
2. Patients diagnosed with acute liver failure, AKI, hypoglycemia.
3. Allergy to the ingredients which will be used in this study
4. Patients with Diabetic ketoacidosis or non ketotic hyperosmolar hyperglycemia
5. Severe hepatic disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups, including a placebo group

Empagliflozin Group

Experimental group

Description:

group (A) for empagliflozin (n=25),

Treatment:

Drug: Empagliflozin 10 MG

Placebo Group

Placebo Comparator group

Description:

group (B) for placebo (n=25)

Treatment:

Other: Placebo Tablet