Clinical trial NCT05778084: Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction
Official title: Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: Empagliflozin
Heart failure with reduced ejection fraction
Nt-proBNP
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open labelled interventional study
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the relationship between NT-proBNP and empagliflozin effects in patients with chronic heart failure with mildly reduced ejection fraction (HFmrEF 41-49%) and reduced ejection fraction (HFrEF ≤40%) whether diabetic or non-diabetic patients.

Detailed description: 1. Ethical Committee approval has been obtained from ethics committee of Faculty of Medicine, Alexandria University.
2. Assigning an informed consent for agreement of participation should be taken by all participants in this clinical study.
3. Heart failure patients with reduced and mildly reduced ejection fraction will be recruited from Alexandria Main University Hospital (AMUH), private hospitals and clinics.
4. A Blood sample will be collected from 60 patients as baseline to test for N-terminal Pro-B-type Natriuretic Peptide.
5. The same 60 patients will take Empagliflozin for 6 months.
6. Another blood sample will be taken from the same 60 patients to test the effect on N-terminal Pro-B-type Natriuretic Peptide after Empagliflozin administration.
7. The appropriate statistical test will be hold according to study design and parameters to evaluate the significant results.
8. Results conclusion discussion and recommendations will be given.

Eligibility criteria: Inclusion Criteria:

* Chronic heart failure with mildly reduced ejection fraction (41-49%) and reduced ejection fraction (≤40%)
* 18-70 years
* Not receiving empagliflozin or any SGLT2 inhibitor
* Elevated plasma NT-proBNP (≥125 pg/ml)
* eGFR ≥ 20 ml/min/1.73m2

Exclusion Criteria:

* Acute Coronary Syndrome (ACS)
* Pulmonary embolism
* Myocarditis
* Valvular heart disease
* Hypertrophic or restrictive cardiomyopathy
* Congenital heart disease
* Pulmonary hypertension
* Surgical procedures involving the heart
* Heart contusion
* Cardioversion, Implantable Cardioverter Defibrillator (ICD) shock
* Patients receiving digoxin
* Advanced age (\>70years)
* Ischemic stroke
* Chronic Obstructive Pulmonary Disease
* Subarachnoid haemorrhage
* Severe infection (including pneumonia and sepsis)
* Anemia
* Renal dysfunction (eGFR \<20ml/min/1.73m2)
* Liver dysfunction (mainly liver cirrhosis with ascites- Child Pugh B \& C)
* Severe burns
* Paraneoplastic syndrome
* Severe metabolic and hormone abnormalities (e.g thyrotoxicosis, diabetic ketosis)

Primary outcomes:
measure: NT-ProBNP
timeFrame: 6 months
Secondary outcomes:
measure: Hemoglobin level g/dl
timeFrame: 6 months
measure: Leukocytes count
timeFrame: 6 months
measure: Sodium level mg/dl
timeFrame: 6 months
measure: Potassium level mg/dl
timeFrame: 6 months
measure: Serum Creatinine
timeFrame: 6 months
measure: Ejection Fraction
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
References: