Back to resultsEmpagliflozin in Heart Failure Dialysis Patients
Primary Purpose
Heart Failure, Hemodialysis
Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Empagliflozin10Mg Tab
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria: Heart failure on dialysis with residual renal function Exclusion Criteria: Dialysis patients with no residual urine
Sites / Locations
- Nooshin DaliliRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Empagliflozin
Arm Description
Heart failure dialysis patients will be treated with Empagliflozin
Outcomes
Primary Outcome Measures
Brain Natriuretic Peptide
serum level
Secondary Outcome Measures
Full Information
NCT ID
NCT05967156
First Posted
July 15, 2023
Last Updated
July 21, 2023
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05967156
Brief Title
Empagliflozin in Heart Failure Dialysis Patients
Official Title
Safety and Efficacy of Empagliflozin on Heart Failure Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Empagliflozin is not still approved for glomerular filtration rate < 20 cc/min/1.73m2. Considering the cardiac and renal benefits of this drug, the evaluation of the safety and efficacy of Empagliflozin for heart failure dialysis patients seems to be mandatory.
Detailed Description
Heart failure dialysis patients with residual renal function will be followed up on Empagliflozin based on echocardiographic parameters, pro-brain natriuretic peptide levels, diuresis volume, and serum acidity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Empagliflozin
Arm Type
Experimental
Arm Description
Heart failure dialysis patients will be treated with Empagliflozin
Intervention Type
Drug
Intervention Name(s)
Empagliflozin10Mg Tab
Other Intervention Name(s)
Abide
Intervention Description
10 mg daily
Primary Outcome Measure Information:
Title
Brain Natriuretic Peptide
Description
serum level
Time Frame
one month after administration
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Heart failure on dialysis with residual renal function
Exclusion Criteria:
Dialysis patients with no residual urine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalili
Phone
9122404331
Ext
0098
Email
dr.nooshindalili@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalili
Organizational Affiliation
SMBU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nooshin Dalili
City
Tehran
ZIP/Postal Code
1666663421
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nooshin Dalili, Dr
Phone
00989122404331
Email
nooshindalili4@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Empagliflozin in Heart Failure Dialysis Patients
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