Diabetes
Conditions
Interventions
Dapagliflozin:None
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old; 2. According to the diagnostic criteria proposed by the WHO diabetes Expert Committee in 1999, the patient meets the diagnosis of type 2 diabetes, that is, one out of three; Note that those without diabetes symptoms need to be confirmed again on another day: (1) diabetes symptoms (polyuria, polydipsia and unexplainable weight loss)+random blood glucose (regardless of the time of last meal and intravenous plasma glucose at any time of the day) = 11.1 mmol/L (200 mg/dl); (2) Fasting blood glucose (FPG) (no caloric intake within 8h) = 7.0mmol/L (126mg/dl); (3)OGTT-2h PG=11. 1mmol/L(200mg/dl) 3. According to the Framingham diagnostic criteria for heart failure and the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018, it is consistent with the diagnosis of HFpEF, that is, there are symptoms of heart failure (dyspnea, cough, hemoptysis, fatigue, palpitation) or physical signs (abdominal swelling, edema, jugular vein distension, etc.); LVEF=50% B-type natriuretic peptide (BNP)>35 ng/L and/or N-terminal pro-B-type natriuretic peptide (NT-proBNP)>125 ng/L and meet at least one of the following criteria: (1) left ventricular hypertrophy and/or left atrial enlargement, and (2) abnormal cardiac diastolic function. 4. New York Heart Association Cardiac Function Classification (NYHA) II, III or IV. The specific classification is as follows: 1) Grade I: The patient has heart disease, but the daily activity is not limited. General physical activity does not cause excessive fatigue, palpitation, asthma or angina pectoris. 2) Grade II: The physical activity of heart patients is slightly restricted. There are no conscious symptoms during rest, and general physical activities cause excessive fatigue, palpitation, asthma or angina pectoris. 3) Level III: The patient has heart disease and physical activity is significantly restricted. No symptoms at rest, but less than normal physical activity can cause excessive fatigue, palpitation, asthma or angina. 4) Grade IV: patients with heart disease cannot engage in any physical activity, and also have heart failure symptoms at rest, which will worsen after physical activity. 5. Being treated with daggliflozin in the past month.
Exclusion criteria
Exclusion criteria: 1. Intolerance to SGLT2i treatment; 2. Type 1 diabetes; 3. Estimated glomerular filtration rate (eGFR)<30 ml/min/1.73m2; 4. Symptoms of hypotension or systolic blood pressure<95 mmHg; 5. Recent worsening of heart failure: acute decompensated heart failure or hospitalization due to heart failure occurred within 4 weeks before enrollment; 6. Serious cardiovascular events: acute coronary syndrome and stroke occurred within 12 weeks before enrollment; 7. Recent cardiac surgery or planned surgery: coronary revascularization/valve surgery within 12 weeks before enrollment, or the above surgery is planned after enrollment; 8. Have CMR contrast agent allergy, metal implants, claustrophobia or clear contraindications to CMR examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NT-proBNP;EAT volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse cardiovascular events;LVEDVI; | — |
Countries
China
Contacts
Public ContactQianzhou Lv
Zhongshan Hospital, Fudan University
Outcome results
None listed