Empagliflozin on Patients With Preserved Heart Failure
- Conditions
- Heart Failure
- Interventions
- Other: Placebo Tablet
- Registration Number
- NCT07112274
- Lead Sponsor
- Damanhour University
- Brief Summary
The proposed research in this application will investigate the effect of empagliflozin on cardiac remodeling in patients with heart failure with preserved ejection fraction.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empagliflozin Group Empagliflozin 10 MG group (A) for empagliflozin (n=25), Placebo Group Placebo Tablet group (B) for placebo (n=25)
- Primary Outcome Measures
Name Time Method NT-ProBNP 3 months Human N-Terminal Pro Brain Natriuretic Peptide (NT-ProBNP)
sST2 3 months soluble suppressor of tumorigenicity 2 (sST2)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rehab Hussein Werida
🇪🇬Damanhūr, Elbehairah, Egypt
Rehab Hussein Werida🇪🇬Damanhūr, Elbehairah, Egypt