Heart FailureNCT05967156
Empagliflozin in Heart Failure Dialysis Patients
A study testing Empagliflozin10Mg Tab in people with Heart Failure and Hemodialysis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Hemodialysis
- What is being tested?
- Empagliflozin10Mg Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 1 Jun 2023to 3 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Heart failure on dialysis with residual renal function
Who cannot join
- Dialysis patients with no residual urine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Empagliflozin on Heart Failure Dialysis Patients
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.
Read the 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.
- Conditions
- Heart Failure, Hemodialysis
- Being tested
- Empagliflozin10Mg Tab
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin10Mg TabDrug
Also called Abide
10 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Heart failure dialysis patients will be treated with Empagliflozin Receives: Drug: Empagliflozin10Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Natriuretic Peptide
serum level
Measured: one month after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
- Investigators
- Dalili, Principal investigator, SMBU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967156
- Sponsor's protocol ID
- SBMU--
- Status last verified
- Jun 2025
- First submitted
- 15 Jul 2023
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Empagliflozin on Heart Failure Dialysis Patients
- ClinicalTrials.gov ID
- NCT05967156
- Acronym / sponsor ID
- SBMU--
- Conditions
- Heart Failure, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin10Mg TabHeart failure dialysis patients will be treated with Empagliflozin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Heart failure on dialysis with residual renal function
Key exclusion criteria (1 listed)
- Dialysis patients with no residual urine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin10Mg TabAlso: Abide10 mg daily | Drug | Empagliflozin |
Primary outcome
Brain Natriuretic Peptide
Time frame: one month after administration
serum level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dalili principal investigator
SMBU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empagliflozin10Mg Tab in people with Heart Failure and Hemodialysis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Natriuretic Peptide (time frame: one month after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.