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Patients with advanced (ACCF/AHA stage D) heart failure and hyperuricemia have high one-year mortality. Currently, there was no evidence-based therapy such as mechanically assisted circulatory support available in China. The investigators found glucocorticoid treatment such as prednisone could improve cardiac performance, potentiate renal responsiveness to diuretics in such patients. Therefore, it could be used as bridge therapy to help ACE inhibitors or beta blocker titration. With its help, most of the patients with stage D heart failure could be titrated to higher dose of ACE inhibitors and beta blockers during hospitalization. However, the efficacy of long-term, low-dose of prednisone use in such patients with limited life expectancy remain unclear. Therefore, the investigators designed this study to observe whether putting low-dose of prednisone on the patients with stage D heart failure for long term could further improve their survival. All patients will receive prednisone treatment during hospitalization and receive maximum tolerated guideline-directed medical therapy (GDMT). After discharge from hospital, the patients will be randomized to receive long-term, low-dose prednisone treatment or standard GDMT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Experimental | Prednisone (10 to 20 mg/day, orally) combined with maximum tolerated guideline-directed medical therapy for at least 12 months. |
|
| Control | No Intervention | Maximum tolerated guideline-directed medical therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisone | Drug | Prednisone (10 to 20 mg/day, orally) combined with maximum tolerated guideline-directed medical therapy for at least 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality within 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival time (defined as time to first hospitalization due to heart failure deterioration or death) within 12 months | 12 | |
| Survival time (defined as time to death) within 12 months | 12 months |
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Inclusion Criteria:
Repeated (>2) hospitalizations or ED visits for HF in the past year
Inability to exercise including exertion limited, exertion intolerance, resting symptoms or inotrope dependent
Left ventricular ejection fraction ≤35%
Serum uric acid level ≥500μmol/L
Received prednisone treatment during hospitalization period and And more 5 of the followings
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23395281 | Background | Liu C, Zhao Q, Zhen Y, Gao Y, Tian L, Wang L, Ji L, Liu G, Ji Z, Liu K. Prednisone in Uric Acid lowering in Symptomatic Heart Failure Patients With Hyperuricemia (PUSH-PATH) study. Can J Cardiol. 2013 Sep;29(9):1048-54. doi: 10.1016/j.cjca.2012.11.008. Epub 2013 Feb 6. | |
| 17876376 | Background | Liu C, Liu G, Zhou C, Ji Z, Zhen Y, Liu K. Potent diuretic effects of prednisone in heart failure patients with refractory diuretic resistance. Can J Cardiol. 2007 Sep;23(11):865-8. doi: 10.1016/s0828-282x(07)70840-1. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Change from baseline in serum uric acid | month 6 and month 12 |
| Change from baseline in serum creatinine | month 6 and month 12 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |