Digoxin and Senolysis in Heart Failure and Diabetes Mellitus

ConditionsHeart Failure, Systolic Diabetes Mellitus, Type 2

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Digoxin 0.125 MG
Drug
One capsule containing digoxin per day for three months

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: PlaceboPlacebo comparator 1 intervention

Group B: DigoxinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

SAT microvascular endothelial cell β-galactosidase

Change in MVEC senescence associated β-galactosidase expression in cultured MVEC will be assessed using CellEvent Senescence Green Detection Kit in fat biopsies.

Time frame

Three months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leeds

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: