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New treatment option for Heart Failure With Preserved Ejection Fraction
Official title EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
ClinicalTrials.gov ID: NCT06249945
What this study is testing
What is Empagliflozin 25 MG?
Empagliflozin 25 MG is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for heart failure with preserved ejection fraction.
Also referred to as Jardiance 25 MG.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- Age ≥20 years old
- ESRD under chronic, maintenance dialysis with stable dry weight for the past 6 months
- Prior diagnosis of HFpEF, as defined by a score of ≥5 on the HFA-PEFF diagnostic algorithm.
You likely can't join if
- Age \<20 years old
- Ongoing pregnancy
- NYHA class IV heart failure
- Any hospitalization for heart failure within the past month Ongoing acute urinary tract infection at the time of screening
- Known acute genital infection
- Severe peripheral artery disease (Rutherford category 4-6)
See the full eligibility criteria
- Age ≥20 years old
- ESRD under chronic, maintenance dialysis with stable dry weight for the past 6 months
- Prior diagnosis of HFpEF, as defined by a score of ≥5 on the HFA-PEFF diagnostic algorithm.
- Age \<20 years old
- Ongoing pregnancy
- NYHA class IV heart failure
- Any hospitalization for heart failure within the past month Ongoing acute urinary tract infection at the time of screening
- Known acute genital infection
- Severe peripheral artery disease (Rutherford category 4-6)
- Acute coronary syndrome, stroke or transient ischemic attack within the past month
- Recent initiation of chronic maintenance hemodialysis within 6 months
- Adjustment of dry weight with changes greater than 5% of body weight within the past month
- Documented left ventricular ejection fraction =\<40% by any imaging modality within 1 month of screening
- Refused informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Hsinchu, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hsinchu, Taiwan; Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.