Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction
NCT ID: NCT05778084
Last Updated: 2023-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2022-12-15
2024-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Heart failure patients with reduced and mildly reduced ejection fraction
* One paired test group described as Heart Failure patients with reduced and mildly reduced ejection fraction are indicated for Empagliflozin.
* Blood samples will be collected as a baseline before Empagliflozin administration to test for N-terminal Pro-B-type Natriuretic Peptide,
* Followed by administration of empagliflozin for 6 months.
* Then retest the N-terminal Pro-B-type Natriuretic Peptide after 6 months.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Locations
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Alexandria University
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0107427
Identifier Type: -
Identifier Source: org_study_id
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