Microvascular Obstruction Treatment and Outcomes Randomized Study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- SAQ questionnaire
研究概览
简要总结
To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction.
详细描述
Objective To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction.
Hypothesis Treatment with titrated nebivolol will result superior to placebo in symptoms control in patients presenting with coronary microvascular disease (CMD).
Study design Prospective, multicenter, controlled, double-blinded, randomized clinical trial.
Inclusion criteria • Patients over 18 years old with symptoms or evidence of myocardial ischemia and coronary arteries without lesions or with epicardial lesions (<50% by visual estimation or FFR >0.80 / RFR >0.90), and
• CFR ≤ 2.0 and/or IMR≥25 Exclusion criteria Life expectancy <1 year, inability to provide informed consent, severe valve disease, left ventricular ejection fraction <30%, clinical contraindication for betablockers treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Presence of stable angina symptoms, defined as compatible symptoms occurring at least once weekly in the last three months.
- •Absence of functionally significant epicardial coronary artery disease (FFR > 0.80).
- •Microvascular functional study showing CFR< 2,0 and/or IMR ≥ 25.
排除标准
- •Allergy or contraindication to the use of beta-blockers.
- •Indication for beta-blocker treatment due to another pathology.
- •Ventricular dysfunction (LVEF < 45%).
- •Percutaneous coronary revascularization in the last 6 months.
- •History of surgical revascularization.
- •First-degree atrioventricular block or bifascicular block.
- •Presence of hemodynamically significant valvulopathy.
- •Presence of cardiomyopathy or congenital cardiac anomaly.
- •Severe renal insufficiency (eGFR < 30 ml/min).
- •Liver failure (history of cirrhosis or transaminase elevation > 3 times the upper limit of normal).
- •Pregnant or lactating women.
研究组 & 干预措施
Active treatment group
Nevibolol tratment
干预措施: Nevibolol (Drug)
Control group
Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
SAQ questionnaire
时间窗: 6 months
The pre-specified primary outcome criterion is the improvement in angina severity assessed by the Seattle Angina Questionnaire (SAQ SS - Summary Score) at 6 months from the start of treatment compared to baseline. It will be evaluated by the mean difference in change within the same patient in SAQ between the two groups at 6 months of treatment. The SAQ is a validated self-administered scale that allows assessment of angina severity, frequency, quality of life, and functional limitation. It is the most commonly used and validated patient-reported outcome measure for angina. The SAQ provides a scale for evaluating the severity of angina that has been shown to be valid, reproducible, and sensitive to changes.
次要结局
- Quality of Life Status using the EuroQOL questionnaire (EQ5D-5L)(6 months)
- the Brief Illness Perception Questionnaire (B-IPQ)(6 months)
- anxiety and depression using PHQ-4(6 months)
- The treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM-9)(6 months)
- Functional Capacity(6 months)
- Major Cardiac Events(6 months)
研究者
Fernando Alfonso
Head of Cardiology Department. H. U. de la Princesa.
Spanish Society of Cardiology