MyoVasc - An Epidemiological Cohort Study to Investigate the Development and Progression of Heart Failure and the Interaction With Vascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,289
- 试验地点
- 1
- 主要终点
- Incidence of Worsening of Heart Failure
研究概览
简要总结
The MyoVasc - Study is an observational, prospective cohort study. The study is investigating the development and progression of the heart failure syndrome, phenotypes of the heterogeneous syndrome, and the interactions of phenotypes with the vasculature regarding their impact for the course of heart failure.
详细描述
"MyoVasc" is an observational cohort study investigating the development and progression of heart failure (HF). The primary objective of the study is: i, to advance the understanding of pathomechanisms of the heterogenous syndrome in the full range of clinical presentation, ii, to evaluate current clinical phenotypes of HF, and iii, to identify and describe homogenous subgroups with regard to disease development using a systems-oriented approach. A special focus is put on the investigation of heart failure with preserved ejection fraction in contrast to the more investigated and established phenotype with reduced ejection fraction. Further aspects comprise inter alia the relevance of metabolic dysregulation, inflammation and coagulation for the course of the disease.
The primary endpoint of the study is the combined outcome "worsening of heart failure" defined as transition from asymptomatic to symptomatic heart failure, hospitalization due to heart failure, or cardiac death. Secondary endpoints are the components of the primary endpoint, myocardial infarction, stroke, hospitalization due to cardiovascular disease, venous thromboembolism, atrial fibrillation, and all-cause death. Disease progression is monitored by a large panel of biomarkers for structure and function of cardiac and vascular systems and related organs.
Individuals aged 35- to 84-years with echocardiographic signs of heart failure irrespective of the clinical status are enrolled and a subsample of controls without heart failure. Individuals were recruited from health institutions and a population sample from the registration office. The study sample comprises approx. 3,200 individuals, of which N~2,700 individuals have heart failure and N~500 individuals are controls. Study participants receive a highly standardized 5-hour baseline examination in the study center with examinations of the cardiovascular system (e.g. anthropometrics, 2D- and 3D-echocardiography, carotid sonography, vascular function, ankle-brachial index, body plethysmography, capacity exercise testing, blood pressure measurements (resting, ABPM), ECG (12-lead, holter), computer-assisted personal interview, and venous blood withdrawal for bio banking). Annual follow-up examinations are performed via computer-assisted telephone interviews tracking comprehensively the participants´ health status, assessing current medication and recording clinical events. Every two years, the participant is invited again to the MyoVasc Study Center for the conduct of sequential follow-up investigations, which are identical to the initial examination.
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
- 35 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic heart failure or symptomatic heart failure
- •Written consent
- •Sufficient knowledge of the German language, in order to understand study documents and computer assisted interview without any translation
排除标准
- •Individuals who are not able to visit the study center due to psychological or physical impairment
- •STEMI within the last 4 months, NSTEMI within the last 3 months
- •Acute decompensated heart failure
- •Surgery, especially coronary artery bypass grafting within the last 3 months
- •Acute disease, especially acute infectious disease, endocarditis, myocarditis or pericarditis
结局指标
主要结局
Incidence of Worsening of Heart Failure
时间窗: Assessment in annual follow-up contacts over a period of 10 years
The primary outcome "worsening of heart failure" differs between groups: * Population Controls: i.e. composite of cardiac death and incident heart failure (i.e. incident asymptomatic or symptomatic heart failure) * Individuals with asymptomatic heart failure: i.e. composite of cardiac death and transition from asymptomatic to symptomatic heart failure * Individuals with symptomatic heart failure: i.e. composite of cardiac death and hospitalization due to worsening of heart failure
次要结局
- Incidence of hospitalization(Assessment in annual follow-up contacts over a period of 10 years)
- Incidence of deep vein thrombosis(Assessment in annual follow-up contacts over a period of 10 years)
- Worsening of exercise capacity as assessed via peak oxygen uptake(Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years)
- Worsening of diastolic cardiac function assessed by mitral inflow signal and tissue doppler of the heart(Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6 and 8 years)
- Incidence of transition from asymptomatic to symptomatic heart failure(Assessment in annual follow-up contacts over a period of 10 years)
- Incidence of cardiac arrhythmia(Continuous assessment throughout the follow-up of the study)
- Incidence of arterial hypertension(Assessment in annual follow-up contacts over a period of 10 years)
- Incidence of stroke or transient ischemic attack(Assessment in annual follow-up contacts over a period of 10 years)
- Incidence of atrial fibrillation(Assessment in annual follow-up contacts over a period of 10 years)
- Incidence of pulmonary embolism(Assessment in annual follow-up contacts over a period of 10 years)
- Worsening of cardiac strain assessed by speckle-tracking of the heart(Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years)
- Incidence of angina pectoris(Assessment in annual follow-up contacts over a period of 10 years)
- Incidence of myocardial infarction(Assessment in annual follow-up contacts over a period of 10 years)
- Worsening of pulmonary function as assessed by FEV1(Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years)
- Incidence of Cardiac death(Assessment in annual follow-up contacts over a period of 10 years)
- Incidence of Hospitalization due to heart failure(Assessment in annual follow-up contacts over a period of 10 years)
- Incidence of heart failure (i.e. incident asymptomatic or symptomatic heart failure) in controls(Assessment in annual follow-up contacts over a period of 10 years)
- Incidence of death(Follow-up of vital status for 10 years)
- Incidence of peripheral artery disease(Assessment in annual follow-up contacts over a period of 10 years)
- Worsening of systolic cardiac function assessed by ventricular ejection fraction(Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years)
- Incidence of revascularization(Assessment in annual follow-up contacts over a period of 10 years)
- Worsening of renal function as assessed by glomerular filtration rate(Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years)
- Worsening of vascular function as assessed by FMD/FMC(Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years)
研究者
Philipp Wild, MD, MSc
Univ.-Prof. Dr. Philipp S. Wild, MD, MSc
Johannes Gutenberg University Mainz