Heart Failure
Conditions
Keywords
Heart Failure
Brief summary
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
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.
Interventions
None listed
Sponsors
Johannes Gutenberg University Mainz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 84 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Worsening of Heart Failure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hospitalization due to heart failure | Assessment in annual follow-up contacts over a period of 10 years | Hospitalization due to heart failure |
| Incidence of transition from asymptomatic to symptomatic heart failure | Assessment in annual follow-up contacts over a period of 10 years | Transition from asymptomatic to symptomatic heart failure |
| 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 | Incident heart failure (i.e. incident asymptomatic or symptomatic heart failure) in controls |
| Incidence of death | Follow-up of vital status for 10 years | Death |
| Incidence of hospitalization | Assessment in annual follow-up contacts over a period of 10 years | Hospitalization |
| Incidence of myocardial infarction | Assessment in annual follow-up contacts over a period of 10 years | Myocardial infarction |
| Incidence of stroke or transient ischemic attack | Assessment in annual follow-up contacts over a period of 10 years | Stroke or transient ischemic attack |
| Incidence of cardiac arrhythmia | Continuous assessment throughout the follow-up of the study | Cardiac arrhythmia |
| Incidence of atrial fibrillation | Assessment in annual follow-up contacts over a period of 10 years | Atrial fibrillation |
| Incidence of angina pectoris | Assessment in annual follow-up contacts over a period of 10 years | Angina pectoris |
| Incidence of deep vein thrombosis | Assessment in annual follow-up contacts over a period of 10 years | Deep vein thrombosis |
| Incidence of Cardiac death | Assessment in annual follow-up contacts over a period of 10 years | Cardiac death |
| Incidence of arterial hypertension | Assessment in annual follow-up contacts over a period of 10 years | Arterial hypertension |
| Incidence of peripheral artery disease | Assessment in annual follow-up contacts over a period of 10 years | Peripheral artery disease |
| 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 | 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 |
| 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 | Assessed via 2D/3D transthoracic cardiac echocardiography by a trained physician |
| Incidence of revascularization | Assessment in annual follow-up contacts over a period of 10 years | Revascularization |
| 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 | Assessed via 2D/3D transthoracic cardiac echocardiography by a trained physician |
| 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 | Assessed via 2D/3D transthoracic cardiac echocardiography by a trained physician |
| 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 renal function as assessed by estimated glomerular Filtration rate (eGFR) as humoral biomarker of renal function |
| 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 | Worsening of forced expiratory volume in one second (FEV1) via body plethysmography |
| 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 | Worsening of flow-mediated dilatation (FMD) and constriction (FMC) of the radial artery |
| Incidence of pulmonary embolism | Assessment in annual follow-up contacts over a period of 10 years | Pulmonary embolism |
Countries
Germany
Outcome results
None listed