NCT02282683

Long-term Prednisone Use for End-stage Heart Failure

Long-term Prednisone Use in Patients With Advanced Heart Failure (ACCF/AHA Stage D) and Hyperuricemia

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Hebei Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Heart Failure
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	prednisone	Prednisone (10 to 20 mg/day, orally) combined with maximum tolerated guideline-directed medical therapy for at least 12 months

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-11-04
• Last updated: 2017-01-12

Locations

1 site across 1 country: China