MyoVasc Study on the Development and Progression of Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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MyoVasc - An Epidemiological Cohort Study to Investigate the Development and Progression of Heart Failure and the Interaction With Vascular Disease

Conditions
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Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure<br>Individuals with asymptomatic or symptomatic heart failure | |
| Population Controls<br>Individuals free of heart failure and echocardiographic cardiac dysfunction | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Assessment in annual follow-up contacts over a period of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Cardiac death | Cardiac death | Assessment in annual follow-up contacts over a period of 10 years | 
| Incidence of Hospitalization due to heart failure | Hospitalization due to heart failure | 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 | 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 | Assessment in annual follow-up contacts over a period of 10 years | 
| Incidence of death | Death | Follow-up of vital status for 10 years | 
| Incidence of hospitalization | Hospitalization | Assessment in annual follow-up contacts over a period of 10 years | 
| Incidence of myocardial infarction | Myocardial infarction | Assessment in annual follow-up contacts over a period of 10 years | 
| Incidence of stroke or transient ischemic attack | Stroke or transient ischemic attack | Assessment in annual follow-up contacts over a period of 10 years | 
| Incidence of cardiac arrhythmia | Cardiac arrhythmia | Continuous assessment throughout the follow-up of the study | 
| Incidence of atrial fibrillation | Atrial fibrillation | Assessment in annual follow-up contacts over a period of 10 years | 
| Incidence of angina pectoris | Angina pectoris | Assessment in annual follow-up contacts over a period of 10 years | 
| Incidence of deep vein thrombosis | Deep vein thrombosis | Assessment in annual follow-up contacts over a period of 10 years | 
| Incidence of pulmonary embolism | Pulmonary embolism | Assessment in annual follow-up contacts over a period of 10 years | 
| Incidence of arterial hypertension | Arterial hypertension | Assessment in annual follow-up contacts over a period of 10 years | 
| Incidence of peripheral artery disease | Peripheral artery disease | 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 | 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 | Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years | 
| Incidence of revascularization | Revascularization | 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 | 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 | 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 | 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 | 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 | Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure