Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection (COVID-19). A Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Median days alive and out of the hospital
研究概览
简要总结
Suspension of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors and Adverse Outcomes in Hospitalized Patients With Coronavirus Infection.
详细描述
Several interactions by pre-existing therapies for chronic diseases, therapies used by SARS-CoV2 infection generate doubts about risks and benefits. Among these situations in which the current data indicate a situation of equipoise would be about the maintenance or suspension of ACEI / BRA in patients with SARS-CoV2 infection. Increasing the expression of ECA-2 could increase the binding to the virus, however, there are studies that indicate this increase in ECA-2 could be protective. So far, there is no clinical evidence to confirm any of the theories, and this question can only be clarified through a randomized clinical trial.
The objective is to evaluate the impact of the suspension of the use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (BRA) on the length of hospital stay and on the mortality of patients with SARS-CoV2 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized with COVID-19 diagnosis using ACE inhibitors or blockers of angiotensin receptor;
- •Patients ≥ 18 years old;
- •Maximum use of 3 antihypertensive drugs;
- •Sign the consent form.
排除标准
- •Severe evolution with orotracheal intubation, use of mechanical ventilation and / or hemodynamic instability in the first 24 hours until COVID-19 diagnosis confirmation;
- •Patients hospitalized per decompensated congestive heart failure in the last 12 months;
- •Use of Sacubitril/Valsartan
- •Pregnancy
- •Recent acute renal failure and shock
结局指标
主要结局
Median days alive and out of the hospital
时间窗: 30 days
The primary outcome of the study will be days alive and outside the hospital (DAOH) at 30 days. This endpoint will be calculated for each included patient and the calculation will be from the date of randomization to the 30-day post-randomization. The DAOH endpoint represents the follow-up time (30 days) subtracted from the hospitalization days and/or the days between death and the end of follow-up.
次要结局
- Number of participants with adverse cardiovascular outcomes and new worsening heart failure(30 days)
- Cardiovascular biomarkers related to COVID-19(up to 30 days)