Effect of Vericiguat vs Placebo on Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction

医学 射血分数 心力衰竭 安慰剂 内科学 随机对照试验 失代偿 心脏病学 心房颤动 利钠肽 生活质量(医疗保健) 病理 护理部 替代医学
作者
Paul W. Armstrong,Carolyn S.P. Lam,Kevin J. Anstrom,Justin A. Ezekowitz,Adrian F. Hernandez,Christopher M. O’Connor,Burkert Pieske,Piotr Ponikowski,Sanjiv J. Shah,Scott D. Solomon,Adriaan A. Voors,Lilin She,Vanja Vlajnic,Francine Carvalho,Luke Bamber,Robert O. Blaustein,Lothar Roessig,Javed Butler
出处
期刊:JAMA [American Medical Association]
卷期号:324 (15): 1512-1512 被引量:215
标识
DOI:10.1001/jama.2020.15922
摘要

Importance

Patients with heart failure and preserved ejection fraction (HFpEF) are at high risk of mortality, hospitalizations, and reduced functional capacity and quality of life.

Objective

To assess the efficacy of the oral soluble guanylate cyclase stimulator vericiguat on the physical limitation score (PLS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ).

Design, Setting, and Participants

Phase 2b randomized, double-blind, placebo-controlled, multicenter trial of 789 patients with chronic HFpEF and left ventricular ejection fraction 45% or higher with New York Heart Association class II-III symptoms, within 6 months of a recent decompensation (HF hospitalization or intravenous diuretics for HF without hospitalization), and with elevated natriuretic peptides, enrolled at 167 sites in 21 countries from June 15, 2018, through March 27, 2019; follow-up was completed on November 4, 2019.

Interventions

Patients were randomized to receive vericiguat, up-titrated to 15-mg (n = 264) or 10-mg (n = 263) daily oral dosages, compared with placebo (n = 262) and randomized 1:1:1.

Main Outcomes and Measures

The primary outcome was change in the KCCQ PLS (range, 0-100; higher values indicate better functioning) after 24 weeks of treatment. The secondary outcome was 6-minute walking distance from baseline to 24 weeks.

Results

Among 789 randomized patients, the mean age was 72.7 (SD, 9.4) years; 385 (49%) were female; mean EF was 56%; and median N-terminal pro–brain natriuretic peptide level was 1403 pg/mL; 761 (96.5%) completed the trial. The baseline and 24-week KCCQ PLS means for the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 60.0 and 68.3, 57.3 and 69.0, and 59.0 and 67.1, respectively, and the least-squares mean changes were 5.5, 6.4, and 6.9, respectively. The least-squares mean difference in scores between the 15-mg/d vericiguat and placebo groups was −1.5 (95% CI, −5.5 to 2.5;P = .47) and between the 10-mg/d vericiguat and placebo groups was −0.5 (95% CI, −4.6 to 3.5;P = .80). The baseline and 24-week 6-minute walking distance mean scores in the 15-mg/d vericiguat, 10-mg/d vericiguat, and placebo groups were 295.0 m and 311.8m , 292.1 m and 318.3 m, and 295.8 m and 311.4 m, and the least-squares mean changes were 5.0 m, 8.7 m, and 10.5 m, respectively. The least-squares mean difference between the 15-mg/d vericiguat and placebo groups was −5.5 m (95% CI, −19.7 m to 8.8 m;P = .45) and between the 10-mg/d vericiguat and placebo groups was −1.8 m (95% CI, −16.2 m to 12.6 m;P = .81), respectively. The proportions of patients who experienced symptomatic hypotension were 6.4% in the 15-mg/d vericiguat group, 4.2% in the 10-mg/d vericiguat group, and 3.4% in the placebo group; those with syncope were 1.5%, 0.8%, and 0.4%, respectively.

Conclusions and Relevance

Among patients with HFpEF and recent decompensation, 24-week treatment with vericiguat at either 15-mg/d or 10-mg/d dosages compared with placebo did not improve the physical limitation score of the KCCQ.

Trial Registration

ClinicalTrials.gov Identifier:NCT03547583
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
3秒前
阿克66完成签到,获得积分10
3秒前
maxthon完成签到,获得积分10
6秒前
神勇的天问完成签到 ,获得积分10
7秒前
任性的白玉完成签到 ,获得积分10
8秒前
9秒前
晨珂完成签到,获得积分10
9秒前
呆萌的小海豚完成签到,获得积分10
10秒前
13秒前
zhangyx完成签到 ,获得积分0
13秒前
松柏完成签到 ,获得积分10
15秒前
踏实谷蓝完成签到 ,获得积分10
15秒前
闪闪火车完成签到 ,获得积分10
17秒前
薄荷味完成签到 ,获得积分10
17秒前
JamesPei应助林二车娜姆采纳,获得30
18秒前
19秒前
东溟渔夫发布了新的文献求助10
21秒前
Wsyyy完成签到 ,获得积分10
21秒前
酷酷小子完成签到 ,获得积分10
24秒前
24秒前
御风完成签到,获得积分10
25秒前
Lucas应助科研通管家采纳,获得10
25秒前
Orange应助东溟渔夫采纳,获得10
26秒前
37秒前
谦让的之柔完成签到,获得积分10
40秒前
40秒前
sunflower完成签到,获得积分0
41秒前
41秒前
孤独如曼完成签到 ,获得积分10
42秒前
45秒前
634301059完成签到 ,获得积分10
46秒前
47秒前
Bazinga完成签到,获得积分10
48秒前
香蕉觅云应助DE2022采纳,获得10
54秒前
零玖完成签到 ,获得积分10
54秒前
WuLunbi完成签到,获得积分10
1分钟前
1分钟前
动听半雪完成签到,获得积分10
1分钟前
故意的松思应助WuLunbi采纳,获得20
1分钟前
DE2022发布了新的文献求助10
1分钟前
高分求助中
Technologies supporting mass customization of apparel: A pilot project 600
Introduction to Strong Mixing Conditions Volumes 1-3 500
Tip60 complex regulates eggshell formation and oviposition in the white-backed planthopper, providing effective targets for pest control 400
A Field Guide to the Amphibians and Reptiles of Madagascar - Frank Glaw and Miguel Vences - 3rd Edition 400
China Gadabouts: New Frontiers of Humanitarian Nursing, 1941–51 400
The Healthy Socialist Life in Maoist China, 1949–1980 400
Walking a Tightrope: Memories of Wu Jieping, Personal Physician to China's Leaders 400
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 物理 生物化学 纳米技术 计算机科学 化学工程 内科学 复合材料 物理化学 电极 遗传学 量子力学 基因 冶金 催化作用
热门帖子
关注 科研通微信公众号,转发送积分 3798555
求助须知:如何正确求助?哪些是违规求助? 3344104
关于积分的说明 10318518
捐赠科研通 3060679
什么是DOI,文献DOI怎么找? 1679753
邀请新用户注册赠送积分活动 806769
科研通“疑难数据库(出版商)”最低求助积分说明 763353