NCT06240403|Not Yet RecruitingPhase 2
Digoxin and Senolysis in Heart Failure and Diabetes Mellitus
Digoxin: a New Senolytic to Repair Dysfunctional Adipose Tissue in Patients With Heart Failure and Type II Diabetes Mellitus
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Digoxin: a New Senolytic to Repair Dysfunctional Adipose Tissue in Patients With Heart Failure and Type II Diabetes Mellitus
Sponsor study identifier
interventional
100
1 country
1
Study Start
September 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 23, 2024
Actual (reported)February 5, 2024
Actual (reported)September 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Three months
Two capsules of placebo taken orally per day for three months
Two capsules containing 62.5mcg digoxin taken orally per day for three months
One capsule containing digoxin per day for three months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS16 5AR, United Kingdom
First Submitted
January 23, 2024
First Posted
February 5, 2024
Study Start
September 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Digoxin for Patients With Non-alcoholic Steatohepatitis (NASH)
DIG-HIF-1 Pharmacodynamic Trial in Newly Diagnosed Operable Breast Cancer
Contact the study team to confirm eligibility.
Primary Completion
August 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 6, 2024
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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