Assessment of extra-renal effects of SGLT2-inhibitors in anuric haemodialysis patients using microneurography

Assessment of the effect of Empagliflozin on sympathetic tone and extra-renal effects in anuric haemodialysis patients using microneurography

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623001237673

Enrollment

Registered

2023-11-30

Start date

2023-12-01

Completion date

2024-01-31

Last updated

2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Sodium Glucose Co-transporter 2 inhibitors (SGLT2i) have been shown to reduce cardiovascular morbidity, mortality and have reno-protective effects. Though their glycosuric effects remain the most studied mechanism, multiple other mechanisms of action have been theorized. This includes extra-renal effects on organs such as the brain, heart, and the sympathetic nervous system (SNS). Increased sympathetic tone is a key feature in various conditions such as chronic kidney disease, type 2 diabetes mellitus, obesity, metabolic syndrome, and heart failure. Limiting the renal effects of SGLT2i by administering them to patients who do not produce urine will allow more accurate assessment of their extra-renal impacts and effectiveness in reducing sympathetic nerve activity. This investigator-led, open-label, prospective, mechanistic study aims to investigate the extra-renal effects of SGLT2i on the SNS, by administering empagliflozin to anuric haemodialysis patients and measuring SNS activity using microneurography of the popliteal nerve, over 6 weeks. We hypothesize that the use of empagliflozin will result in reduced sympathetic drive, which in turn would add mechanistic proof to the extra-renal benefits of SGLT2i.

Interventions

Effects of Empagliflozin on Sympathetic Nervous System; assessed using microneurography - the dose administered, 25mg once daily in the morning, - the duration of administration, 6 weeks, then stop - the mode of administration, oral tablet, - Strategies used to monitor adherence to the intervention: smart phone reminder, pill counting, and reminder on dialysis sessions,

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Adults 18 years and older • Anuric haemodialysis patients • Able to mobilise independently • BP <160/90 mmHg

Exclusion criteria

• Patients with Type 1 Diabetes • Patients on SGLT2-inhbitors prior to the study will be excluded. • History of Unilateral or Bilateral Nephrectomy, chronic liver disease, heart failure [New York Heart Association (NYHA) class II-IV}, or secondary hypertension • Pregnancy (females of childbearing potential must have negative pregnancy test) • Relative or absolute contraindication to empagliflozin, including active urinary or genital tract infection, or known drug allergy • Severe peripheral vascular disease or neuropathy • Initiation of alpha-blockers, beta-blockers or moxonidine within the preceding 6 weeks • Cardiovascular event(s) within the last 6 months • Unstable psychiatric condition or inability to understand and attend appointments • On medications such as corticosteroids, multiple antidepressants, and antipsychotics

Outcome results