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Empagliflozin in Heart Failure Dialysis Patients

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05967156
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
9
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Empagliflozin10Mg Tab
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Empagliflozin on Heart Failure Dialysis Patients
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Empagliflozin

Heart failure dialysis patients will be treated with Empagliflozin

Drug: Empagliflozin10Mg Tab
10 mg daily
Other Names:
  • Abide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Brain Natriuretic Peptide [one month after administration]

      serum level

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Heart failure on dialysis with residual renal function
    Exclusion Criteria:
    • Dialysis patients with no residual urine

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nooshin Dalili Tehran Iran, Islamic Republic of 1666663421

    Sponsors and Collaborators

    • Shahid Beheshti University of Medical Sciences

    Investigators

    • Principal Investigator: Dalili, SMBU

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    nooshin dalili, Assistant Professor, Shahid Beheshti University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05967156
    Other Study ID Numbers:
    • SBMU--
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure
    Empagliflozin

    Study Results

    No Results Posted as of Aug 1, 2023