NCT06240403Not 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
Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 23 Jan 2024
- Start date
- 1 Sept 2025
- Primary completion date
- 28 Aug 2028
- Lead sponsor
- University of Leeds
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT06240403
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 1 Sept 2025 to the primary completion date, 28 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current/previous (\<6m) participation in other studies.
Other illness
- Significant cognitive impairment,
Lab values
- eGFR\<30ml/min/1.73m2
Other
- Important co-morbidity limiting ability to comply with study procedures,
- Hyperkalemia (\>5.5mmol/L)
Who the study is looking for
- 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,
- Able/prepared to give informed written consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leeds Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.