Effects of Dapagliflozin as Added Therapy in Diabetic Patients With Heart Failure With Reduced Ejection Fraction
This study aims to evaluate the effects of Dapagliflozin as an additional therapy on heart function, specifically diastolic function, LV dimensions, and systolic function, in diabetic patients with heart failure with reduced ejection fraction.
Dapagliflozin 10 MG
+ Placebo oral tablet
Cardiovascular Diseases+6
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 2
Treatment Study
Summary
Study start date: March 1, 2020
Actual date on which the first participant was enrolled.This study aims to explore the effects of Dapagliflozin, a medication that inhibits sodium-glucose cotransporter 2, on heart health, illness, and mortality in patients living with type 2 diabetes. The secondary goal is to observe changes in fibrosis and oxidative stress markers and how they relate to the progression of heart disease. The study is particularly important for diabetic patients with heart failure with reduced ejection fraction, as it could potentially offer a new treatment approach to improve their condition. Participants in this study will be divided into two groups after obtaining ethical committee approval and participant consent. One group will receive the standard therapy for diabetes and heart failure, while the other group will receive Dapagliflozin in addition to the standard therapy. The treatment will last for at least three months. All participants will undergo a full patient history and clinical examination, routine follow-ups, and echocardiography before the start and after completion of the study. The study will measure various aspects of heart function, including LV dimensions, systolic function, and diastolic function, to evaluate the effectiveness of Dapagliflozin as an added therapy.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Subjects with type-2 diabetes history \>=5 years 2. HbA1C 6-10% with glucose control medications including insulin, metformin or sulfonylurea 3. Medically stable 4. Willing to participate and sign informed consent. Exclusion Criteria: 1. GFR \<60 mL/min/1.73 m2 2. Unstable or rapidly progressive renal disease 3. Hypotension with SBP \<100 mmHg 4. Hypersensitivity to dapagliflozin or any excipients 5. Patients with severe hepatic impairment (Child-Pugh class C) 6. Patients with active hepatitis B or C infection 7. Any of the following CV/Vascular Diseases within 3 months prior to signing the consent at enrollment, as assessed by the investigator: 1. Myocardial infarction 2. Cardiac surgery or revascularization (CABG/PTCA) 3. Unstable angina 4. HF New York Heart Association (NYHA) Class IV 5. Transient ischemic attack (TIA) or significant cerebrovascular disease 6. Unstable or previously undiagnosed arrhythmia 7. Established PAD
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives