Medication Strategies in Heart Failure Patients Who Are Intolerable to Guideline-directed Medical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Worsening heart failure events in 180 days
研究概览
简要总结
SEMI trial is a single-center, real-world based prospective cohort study. The study enrolled acute heart failure patients admitting to the hospital and intended to accept heart failure therapy. The current guideline recommend ACEI/ARB/ARNI, β blocker, SGLT2i and MRA as the cornerstone medication of HFrEF therapy, but a part patients were intolerable to GDMT because of hypotension, hyperkalemia or renal insufficency. Vericiguat is a new medication therapy choice for the patients with heart failure with reduced ejection fraction (HFrEF), it may has less influence on blood pressure, it is unkonwn about the efficacy and safety of vericiguat in patients who were intolerable to GDMT.
详细描述
The study aim to provide evidence of medication strategy in heart failure patients, especially for patients who are intolerable for GDMT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Sent to the Department of Cardiovascular disease of The First Affiliated Hospital of Chongqing Medical University for inpatient treatment.
- •Diagnosed with acute heart failure or acute exacerbation of chronic heart failure
- •Patients with typical heart failure symptoms and signs such as dyspnea, fatigue after exercise, paroxysmal nocturnal dyspnea, lower limb edema, lung auscultation rale, etc.
- •Left ventricular ejection fraction measured by echocardiogram ≤ 45% and patients had elevated level of NT-proBNP (patients<55 years, NT-proBNP>450 pg/mL; patients≥55 years and <75 years, NT-proBNP>900 pg/mL; patients ≥ 75 years, NT-proBNP>1800 pg/mL)
- •New York Heart Association functional class II to IV.
排除标准
- •Left ventricular ejection fraction measured by echocardiogram > 45% or diagnosed with heart failure with preserved ejection fraction.
- •Age ≤ 18 years old.
- •Allergic to anti-heart failure medications including ACEI/ARB/ARNI, beta blockers, SGLT2i, oral diuretics and vericiguat.
- •Diagnosed as other diseases with symptoms similar to heart failure such as acute exacerbation of chronic obstructive pulmonary disease, etc.
- •Dignosed with acute coronary syndrome, including unstable angina, non ST-elevation myocardial infarction and ST-elevation myocardial infarction. Received percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to the trial start, or indication for PCI or CABG at the trial start.
- •Hepatic insufficiency classified as Child-Pugh B or C.
- •Diagnosed with restrictive cardiomyopathy.
- •Diagnosed with cardiac amyloidosis, Fabry disease or other rare cardiomyopathy.
- •Diagnosed with systematic lupus erythematosus or other autoimmune disease.
- •Diagnosed with or suspect diagnosed with active tumor.
- •Diagnosed with idiopathic pulmonary hypertension, receiving PDE-5 inhibitor or other sGC stimulators.
- •Pregnant woman.
- •Combined with severe infection at admission or combined with uncontrolled tuberculosis.
- •Diagnosed with severe and uncontrolled congenital heart disease.
- •Patients with rheumatic valvular disease who have indications for surgery but have not undergone surgical treatment.
结局指标
主要结局
Worsening heart failure events in 180 days
时间窗: 180 days
Risk of death, readmission due to heart failure or accepting intravenous diuretic therapy in 180 days
次要结局
- Change in N-terminal pro-B type natriuretic peptide(180 days)
- Change in left ventricular end-systolic diameter (LVESD)(180 days)
- Change in blood pressure(180 days)
- Change in left ventricular fractional shortening (LVFS)(180 days)
- Change in left ventricular end-diastolic diameter (LVEDD)(180 days)
- Change in blood potassium(180 days)
- Change in left ventricular ejection fraction (LVEF)(180 days)
研究者
Dongying Zhang
Professor
Chongqing Medical University