Digoxin and Senolysis in Heart Failure and Diabetes Mellitus
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leeds
About this trial
In pilot studies the investigators have shown that subcutaneous adipose tissue (SAT) from patients with reduced ejection fraction heart failure (HFrEF) and type 2 diabetes mellitus (T2DM) is dysfunctional. Endothelial cells from the adipose tissue from these patients are senescent and have deleterious effects on healthy human subcutaneous adipocytes, including increasing expression of IL-6 (gene and protein) and reducing glucose uptake. Digoxin, a well-established treatment for HFrEF, selectively clears these senescent endothelial cells and prevents adipocyte dysfunction. This study will examine the effect of digoxin on adipose tissue on the burden of senescent cells.
Eligibility criteria
Qualifiers
Aged ≥18yrs,
HFrEF (LVEF<40%)
T2DM (taking anti-diabetic medication, fasting plasma glucose ≥7.0 mmol/L and/or a serum HbA1c >48mmol/L
On optimal medical therapy,
Disqualifiers
Significant cognitive impairment,
Important co-morbidity limiting ability to comply with study procedures,
Hyperkalemia (>5.5mmol/L)
eGFR<30ml/min/1.73m2
Trial design
Treatments tested in this trial
- Digoxin 0.125 MG
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov