NCT05021419已完成不适用
Efficacy of a Streamlined Heart Failure Optimisation PRoTocol for Patients with Severely Impaired Left Ventricular Systolic Function, a Randomised Controlled Trial (SHORT Trial)
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time to point of optimization
研究概览
简要总结
The SHORT trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial.
详细描述
The SHORT trial compares the current standard optimization protocol to a shortened protocol in a randomized control trial. It assesses whether an accelerated protocol leads to faster optimization and a greater degree of optimization.
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
- •Ejection fraction of less than or equal to 40%
- •Increased NT-proBNP level:
- •≥ 600 pg per milliliter or
- •≥400 pg per milliliter if they had been hospitalized for heart failure within the previous 12 months or
- •patients with atrial fibrillation or atrial flutter on baseline electrocardiography were required to have an NT-pro BNP level of at least 900 pg per milliliter, regardless of their history of hospitalization for heart failure or
- •recent heart failure admission or clinical diagnosis of heart failure.
- •Patients who are either naïve to or taking no more than 25% target doses of Beta Blockers or ACEi or ARB before starting the trial.
排除标准
- •Systolic BP of less than 100 mmHg on 2 consecutive measurements
- •Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
- •Type 1 diabetes mellitus
- •Cognitive impairment that in the opinion of the investigator may lead the patient to be unable to understand and/or comply with the study medications, procedures and/or follow-up
- •Uncorrected primary valvular disease
- •Active malignancy treatment at time of visit 1
- •Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is reliable in the judgement of the investigator*
- •Women who are pregnant or breastfeeding
- •History of angioedema, or hereditary or idiopathic angioedema
- •Severe hepatic impairment, biliary cirrhosis or cholestasis
- •Patients who are receiving treatment with an aliskiren-containing product who have diabetes mellitus or renal impairment (eGFR <60 ml/min/1.73 m2)
- •Highly effective methods of contraception include implants, injectables, combined oral contraceptives (the participant must have been on a stable dose for at least 3 months before entering the trial), intrauterine device, vasectomised partner, or true sexual abstinence (when this is the preferred and usual lifestyle of the patient and does not include periodic abstinence [e.g. calendar, ovulation, symptothermal or post-ovulation methods]). Use of such methods must be maintained throughout the trial and for 7 days after the end of the trial.
结局指标
主要结局
Time to point of optimization
时间窗: Maximum follow-up 6 months
Do patients on the streamlined protocol reach the point of optimization\* earlier? \*point of optimization is defined as the point in time at which no medication could be increased further either due to achievement of target doses or limited by symptoms, low heart rate, BP, or raised serum potassium or serum Creatinine.
次要结局
- Degree of optimization reached(Maximum follow-up 6 months)
- Number of appointments required(Maximum follow-up 6 months)
- Number of Complications(Maximum follow-up 6 months)
- Change in NT-pro BNP(6 months)
- Symptomatic change(6 months)
- Composite of cardiovascular death and worsening heart failure(6 months)
研究者
研究点 (2)
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