EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease

Sponsor
National Taiwan University Hospital
Study ID
NCT06249945
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 25 MG — DRUG
    The medication will be packed in a customized sealed jar and labeled on the exterior of the jar.
  • Placebo — DRUG
    The placebo tablet is manufactured by Prince Pharmaceutical Co., Ltd, a leading manufacturer of nutritional supplements with certifications including cGMP, GMP, ISO, and HACCP. The Prince Pharmaceutical also provides Original Equipment Manufacturing (OEM)/Original Design Manufacturing (ODM) services for a wide array of tablet shapes, and post-processing techniques such as film coating and sugar coating.

Study Details

The presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited. SGLT2i are one of the few drug classes that have proven efficacy in HFpEF in randomized controlled trials. The results of mechanistic studies suggest that the benefits of SGLT2i on diastolic heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Despite the significance of HFpEF in patients with CKD, patients with advanced kidney disease have been excluded from studies investigating anti-heart failure drugs. The effects of SGLT2i in patients under maintenance dialysis are largely unknown. Past pharmacokinetics and pharmacodynamics studies on empagliflozin in patients with end-stage renal disease (ESRD) demonstrated that the use of empagliflozin in patients with ESRD seemed safe, yet its efficacy remains to be explored.

Key Dates

Start date
Mar 5, 2024
Status verified
Nov 2024
Primary completion
Dec 31, 2027
Completion
Dec 31, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: empagliflozin
    Jardiance, 25 mg, QD, for 6 months
  • Placebo Comparator: Placebo
    QD, for 6 months

Primary Outcome Measure

Mitral early (E) and late (A) diastolic filling velocity ratio (E/A) [ Time Frame: 24 weeks of treatment ]

Central Contacts

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