Clinical trial
Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction
Name
0107427
Description
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.
Trial arms
Trial start
2022-12-15
Estimated PCD
2024-06-15
Trial end
2024-12-15
Status
Recruiting
Phase
Early phase I
Treatment
Empagliflozin 10 MG
Blood samples will be collected as a baseline to test for N-terminal Pro-B-type Natriuretic Peptide, followed by administration of empagliflozin for 6 months, and then another blood samples will be collected after 6 months.
Arms:
Heart failure patients with reduced and mildly reduced ejection fraction
Size
60
Primary endpoint
NT-ProBNP
6 months
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open labelled interventional study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-03-21
1 organization
1 product
1 indication
Organization
Alexandria UniversityProduct
Empagliflozin