| Trial ID: | L6652 |
| Source ID: | NCT06632561
|
| Associated Drug: |
Empagliflozin 10 Mg
|
| Title: |
Benefits of Empagliflozin in Patients With Heart Failure and Reduced Ejection Fraction Without Diabetes Mellitus
|
| Acronym: |
HFrEF
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Heart Failure With Reduced Ejection Fraction
|
| Interventions: |
DRUG: Empagliflozin 10 mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: The changes in LV volumes (mL), To measure the changes in of Left Ventricular end-diastolic volume (LVEDV) (mL) and Left Ventricular end-systolic volume (LVESV) (mL) via transthoracic echocardiography using the modified Simpson's rule (the biplane disk summation approach). Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups., From enrollment to the end of treatment at 6 months|The changes in of Left Ventricular Ejection Fraction (LVEF) (%), To measure the changes in of Left Ventricular Ejection Fraction (LVEF) (%) via transthoracic echocardiography using the modified Simpson's rule (the biplane disk summation approach). Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups., From enrollment to the end of treatment at 6 months | Secondary: The changes in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL), Measurement of N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL) at baseline and at the end of treatment phase after 6 months within both study arms via the electrochemiluminescence immunoassay "ECLIA". Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups., From enrollment to the end of treatment at 6 months|The changes in 6 minute walk test (meters), Measurement of 6 minute walk test (meters) at baseline and at the end of treatment phase after 6 months within both study arms. Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups., From enrollment to the end of treatment at 6 months|The changes in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (points), Measurement of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (points) at baseline and at the end of treatment phase after 6 months within both study arms. Then the change from baseline to the 6th month was compared within each group separately and the means of variables were compared between both groups., From enrollment to the end of treatment at 6 months | Other: a (five points or more) improvement in the Minnesota Living with Heart Failure Questionnaire, Since a five point change in MLHFQ is considered clinically meaningful, we have performed an exploratory analysis to compare the proportion of patients with ≥5 points improvement in MLHFQ in both groups., From enrollment to the end of treatment at 6 months
|
| Sponsor/Collaborators: |
Sponsor: Ashraf Wasfy Beshay Aziz
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
74
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-07-26
|
| Completion Date: |
2022-03-14
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-09
|
| Locations: |
Beni-Suef University, BeniSuef, 62521, Egypt
|
| URL: |
https://clinicaltrials.gov/show/NCT06632561
|
