Efficacy and Safety of 1-Hour Infusion of Recombinant Human Atrial Natriuretic Peptide in Patients With Acute Decompensated Heart Failure
| Autor: | Xiao-Jun Luan, Wei Li, Yuhui Zhang, Jie Huang, Xin-Hai Ni, Shu-Gong Bai, Huimin Li, Dayi Hu, Yihong Hua, Dong-Ye Li, Jun-Zhu Chen, Hui-qiong Tan, Yi Mao, Yi-Shi Li, G Q Wang, Yang Zhen, Xian Wang, Tongguo Wu, Wenxian Liu, Si-Jia Wang, Xiao-Lu Sun, Zhong-kai Liao, Li-tian Yu, Yu Chen, Lei Feng, Ji-Hong Zhu, Shao-Dong Ye, Lang Hong, Jian Zhang, Jian-Hui Sun, Yang Wang, Ping Yang, Pengbo Wang |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
Acute decompensated heart failure business.industry General Medicine 030204 cardiovascular system & hematology medicine.disease Placebo law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Heart failure Anesthesia Multicenter trial Cardiovascular agent Clinical endpoint medicine Physical therapy 030212 general & internal medicine Pulmonary wedge pressure business |
| Zdroj: | Medicine. 95:e2947 |
| ISSN: | 0025-7974 1400-5719 |
| DOI: | 10.1097/md.0000000000002947 |
| Popis: | The aim of the study was to evaluate the efficacy and safety of 1-h infusion of recombinant human atrial natriuretic peptide (rhANP) in combination with standard therapy in patients with acute decompensated heart failure (ADHF). This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Eligible patients with ADHF were randomized to receive a 1-h infusion of either rhANP or placebo at a ratio of 3:1 in combination with standard therapy. The primary endpoint was dyspnea improvement (a decrease of at least 2 grades of dyspnea severity at 12 h from baseline). Reduction in pulmonary capillary wedge pressure (PCWP) 1 h after infusion was the co-primary endpoint for catheterized patients. Overall, 477 patients were randomized: 358 (93 catheterized) patients received rhANP and 118 (28 catheterized) received placebo. The percentage of patients with dyspnea improvement at 12 h was higher, although not statistically significant, in the rhANP group than in the placebo group (32.0% vs 25.4%, odds ratio=1.382, 95% confidence interval [CI]: 0.863-2.212, P = 0.17). Reduction in PCWP at 1 h was significantly greater in patients treated with rhANP than in patients treated with placebo (-7.74 ± 5.95 vs -1.82 ± 4.47 mm Hg, P 0.99). 1-h rhANP infusion appears to result in prompt, transient hemodynamic improvement with a small, nonsignificant, effect on dyspnea in ADHF patients receiving standard therapy. The safety of 1-h infusion of rhANP seems to be acceptable. (WHO International Clinical Trials Registry Platform [ICTRP] number, ChiCTR-IPR-14005719.). |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|