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.
"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.
Study Type
OBSERVATIONAL
Enrollment
3,289
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, Germany
Incidence of Worsening of Heart Failure
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
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of Cardiac death
Cardiac death
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of Hospitalization due to heart failure
Hospitalization due to heart failure
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of transition from asymptomatic to symptomatic heart failure
Transition from asymptomatic to symptomatic heart failure
Time frame: 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
Incident heart failure (i.e. incident asymptomatic or symptomatic heart failure) in controls
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of death
Death
Time frame: Follow-up of vital status for 10 years
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Incidence of hospitalization
Hospitalization
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of myocardial infarction
Myocardial infarction
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of stroke or transient ischemic attack
Stroke or transient ischemic attack
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of cardiac arrhythmia
Cardiac arrhythmia
Time frame: Continuous assessment throughout the follow-up of the study
Incidence of atrial fibrillation
Atrial fibrillation
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of angina pectoris
Angina pectoris
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of deep vein thrombosis
Deep vein thrombosis
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of pulmonary embolism
Pulmonary embolism
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of arterial hypertension
Arterial hypertension
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of peripheral artery disease
Peripheral artery disease
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Worsening of exercise capacity as assessed via peak oxygen uptake
Assessment of peak oxygen uptake via cardiopulmonary exercise testing under consideration of the circulatory (blood pressure, heart rate, electrocardiogram) and respiratory response (ventilatory anaerobic threshold and reserve) by a trained physician
Time frame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
Worsening of systolic cardiac function assessed by ventricular ejection fraction
Assessed via 2D/3D transthoracic cardiac echocardiography by a trained physician
Time frame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
Incidence of revascularization
Revascularization
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Worsening of diastolic cardiac function assessed by mitral inflow signal and tissue doppler of the heart
Assessed via 2D/3D transthoracic cardiac echocardiography by a trained physician
Time frame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6 and 8 years
Worsening of cardiac strain assessed by speckle-tracking of the heart
Assessed via 2D/3D transthoracic cardiac echocardiography by a trained physician
Time frame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
Worsening of renal function as assessed by glomerular filtration rate
Worsening of renal function as assessed by estimated glomerular Filtration rate (eGFR) as humoral biomarker of renal function
Time frame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
Worsening of pulmonary function as assessed by FEV1
Worsening of forced expiratory volume in one second (FEV1) via body plethysmography
Time frame: 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
Worsening of flow-mediated dilatation (FMD) and constriction (FMC) of the radial artery
Time frame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years