Dapagliflozin Effects on Coronary Calcium and Epicardial Fat Assessed by Cardiotomography

Sponsor
Hilda Elizabeth Macías Cervantes
Study ID
NCT05998525
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10Mg Tab — DRUG
    patients who meet the inclusion criteria and after catheterization will be randomized to receive Dapagliflozin 10 mg every 24 hours and upon dischargetreatment will continue for 12 months
  • Placebo — DRUG
    patients who meet the inclusion criteria and after catheterization will be randomized to receive a placebo pill 24 hours and upon discharge treatment will continue for 12 months

Study Details

Calcification of the coronary arteries is a direct sign of atherosclerotic disease of the coronary arteries and has been shown to be a strong predictor of the risk of cardiovascular diseases, including myocardial infarction and/or cardiac death, especially in patients with Diabetes Mellitus type 2. Therefore, there is great interest in pharmacotherapies that improve the rates of cardiovascular complications, and modify the outcomes of this group of patients. Large randomized controlled trials with SGLT2 inhibitors in patients with DM2 have shown a clear reduction in cardiovascular events among individuals with atherosclerotic disease. Atherosclerosis imaging allows measurable assessments of disease progression and activity, revealing early signs of potential drug effects. Noninvasive methods are preferred for serial imaging in drug trials due to the potential risks associated with invasive procedures. The coronary artery calcium quantification using the Agatston score is the most widely used method

Key Dates

Start date
Jun 21, 2021
Status verified
Aug 2023
Primary completion
Dec 30, 2022
Completion
Jun 1, 2023

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10 mg orally every 24 hours for 12 months
  • Placebo Comparator: Placebo
    Placebo orally every 24 hours for 12 months

Primary Outcome Measure

Changes in the coronary calcium score quantified by Agatston's score using simple coronary tomography. Quantified in agatston units (AU) [ Time Frame: A baseline tomography will be performed at the time of randomization and at 12 months of follow-up. ]

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