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Double blind packaged drug is up to expiration date
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In the treatment of heart failure (HF), SGLT-2 inhibitor (SGLT-2i) can significantly improve the clinical outcome and quality of life related to HF. The current data show that SGLT-2i is effective and safe in improving HF outcomes in patients with chronic kidney disease (CKD) stage 4, but there is little clinical evidence in patients with eGFR<20 ml/min/1.73 m2. Therefore, our research is designed to confirm that SGLT-2i can improve the outcome of HF in patients with chronic heart failure with reduced ejection fraction (HFrEF) and severe chronic renal insufficiency (eGFR<20ml/min/1.73m2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT-2 inhibitor | Drug | dapagliflozin |
|
| Measure | Description | Time Frame |
|---|---|---|
| The quality of Life | The change of Quality of Life in patients by using the The Kansas City Cardiomyopathy Questionnaire(KCCQ) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The quality of Life | The change of Quality of Life in patients by using the KCCQ | 2 weeks, 4weeks and 8weeks |
| Dose changes of diuretics | Dose changes of diuretics in subgroups of patients without dialysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Please Select | 100044 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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| 12 weeks |
| Changes of eGFR | Changes of eGFR in the subgroup of non-dialysis patients at 2 and 12 weeks | 2 and 12 weeks |
| Changes of brain natriuretic peptide (BNP) | Changes of BNP | 12 weeks |
| Changes of body weight | Changes of Body weight and BMI | 12 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D045505 | Physiological Effects of Drugs |