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Effect of dapagliflozin on ventricular arrhythmias

Evaluation of the effects of dapagliflozin on frequency of the ventricular arrhythmias in heart failure patients with an implantable cardioverter-defibrillator

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120520009801N10
Enrollment
64
Registered
2023-05-28
Start date
2023-07-23
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular arrhythmia. Re-entry ventricular arrhythmia

Interventions

Intervention 1: Intervention group: Taking dapagliflozin 10 mg tablets, once daily in the morning, regardless of food, for 180 days (number= 32). Intervention 2: Control group: Taking placebo tablets

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age older than 18 years old Heart failure diagnosis ICD implantation > 6 months before eligibility test Signed, written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Using SGLT2 inhibitors before the eligibility test New York Heart Association Class IV heart failure Renal dysfunction (eGFR 3 times higher than upper limit of normal) Body mass index < 18.5 kg/m2 Pregnant or suspected pregnancy Patients with the following events within 6 months before the eligibility test: alteration of antiarrhythmic drug, catheter ablation for ventricular arrhythmia, coronary revascularization, open-heart surgery, development of coronary artery disease, stroke or transient ischemic stroke, seizure, infection requiring hospitalization, heart failure requiring hospitalization Other comorbidities including various infections, major surgery, type 1 diabetes, pituitary or adrenal insufficiency, cancer ICDs unable to record cardiac arrhythmias Serious side effects in patient during the study. e.g. hypersensitivity Drug Intolerance Patient desire to exclude

Design outcomes

Primary

MeasureTime frame
Frequency of the ventricular arrhythmias (PVC, NSVT, VT, VF). Timepoint: During the 6 months before the intervention and along the 6 months of the intervention. Method of measurement: ICD (implantable cardioverter-defibrillator) record.

Secondary

MeasureTime frame
Hospitalization. Timepoint: During the 6 months before the intervention and along the 6 months of the intervention. Method of measurement: Questionnaire.;Oxygen saturation of the arterial blood (SaO2). Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Pulse oximeter device.;Blood glucose. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Laboratory.;Blood pressure. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Sphygmomanometer.;Lipid profile. Timepoint: Before the intervention and 6 months after the intervention. Method of measurement: Laboratory.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Hooshang Mohammadpour

Mashhad University of Medical Sciences

mohamadpoorah@mums.ac.ir+98 51 1882 3255

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026