Study of Prevalence of Amyloidosis in Heart Failure (PREVAMIC).
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Prevalence
研究概览
简要总结
TITLE: Study of Prevalence of Amyloidosis in Heart Failure: PREVAMIC.
DESIGN: Multicenter, observational, cross-sectional, prospective, cohort study with a one-year follow-up. 44 hospitals from Spain will participate.
OBJECTIVES. PRIMARY: To estimate the current prevalence of different types of cardiac amyloidosis (CA) in patients with heart failure, aged 65 years and older, with LVH > 12 mm and any LVEF value, managed in Internal Medicine departments. SECONDARY: To describe the clinical, laboratory and echocardiographic features of patients with CA. To compare one-year readmissions and mortality rates in patients with and without CA.
INCLUSION CRITERIA: Inpatients or outpatients with heart failure, aged ≥ 65 years, both genders, under the care of internists. They should have a NYHA Class II-IV, echocardiogram performed in the previous 24 months, any value of LVEF, LVH: septum or posterior wall > 12 mm, diuretic treatment in the last 6 months and NTproBNP> 1800 pg/ml or BNP> 400 pg/ml in acute hear failure, or NT-proBNP >600 pg/ml o BNP >150 pg/ml in stable condition.
POPULATION: Heart failure outpatients or inpatients of Internal Medicine Services. It is expected to include around 450 patients.
ANALYSIS: To calculate the prevalence of TTR-CA and other types of CA. To compare the clinical, analytical, echocardiographic, and readmissions and mortality rates during one-year in patients with and without CA.
详细描述
STUDY DESIGN AND PATIENT SELECTION
DESIGN
Multicenter, observational, cross-sectional, prospective, cohort study with a one-year follow-up. Approximately 450 patients will be gathered (according to the calculation of the sample size, 382 patients would be necessary), of both sexes (with stratification Male:Female 1:1), age ≥ 65 years, under the care of Internal Medicine Services, who meet the criteria of the 2016 Heart Failure Guide of the European Society of Cardiology for the diagnosis of Heart Failure, and that have LVH (Septum or Posterior Wall > 12 mm).
Patients will be duly informed of the study and their written informed consent will be requested prior to their enrollment in the study.
Once included in the study a series of clinical, analytical and echocardiographic parameters will be collected and measured.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years.
- •Both genders
- •Heart failure outpatients or inpatients of Internal Medicine Services.
- •Heart Failure (Criteria of HF European Guide 2016)
- •Symptoms of HF
- •NYHA class II to IV
- •Echocardiogram performed in the previous 24 months
- •FEVI: any value
- •HVI: Septum or Posterior Wall > 12 mm
- •Diuretic treatment in the last 6 months
- •NTproBNP > 1800 or BNP > 400 during any hospital admission, or NTproBNP > 600 or BNP > 150 in a stable situation.
排除标准
- •Patients with cancer disease (solid tumor)
- •Patients who are included in other studies or clinical trial
- •Refusal of patients to participate
结局指标
主要结局
Prevalence
时间窗: Through study completion, an average of one year.
To estimate the current prevalence of different types of Cardiac Amyloidosis in patients with Heart Failure, age ≥ 65 years, with left ventricular hypertrophy (LVH)\> 12 mm, and any LVEF value, under the care of internists in different Spanish Hospitals.
次要结局
- Patients characteristics(One year)
- Prognosis(One year)