Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Failure | Individuals with asymptomatic or symptomatic heart failure | ||
| Population Controls | Individuals free of heart failure and echocardiographic cardiac dysfunction |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Worsening of Heart Failure | The primary outcome "worsening of heart failure" differs between groups:
| Assessment in annual follow-up contacts over a period of 10 years |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Individuals with asymptomatic and symptomatic heart failure and Population Controls
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philipp S Wild, MD, MSc | University Medical Center of the Johannes Gutenberg University Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center of the Johannes Gutenberg-University Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33533883 | Background | Trobs SO, Prochaska JH, Schwuchow-Thonke S, Schulz A, Muller F, Heidorn MW, Gobel S, Diestelmeier S, Lerma Monteverde J, Lackner KJ, Gori T, Munzel T, Wild PS. Association of Global Longitudinal Strain With Clinical Status and Mortality in Patients With Chronic Heart Failure. JAMA Cardiol. 2021 Apr 1;6(4):448-456. doi: 10.1001/jamacardio.2020.7184. | |
| 33939298 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood, Urine
| 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 |
| Dahlen B, Schulz A, Gobel S, Trobs SO, Schwuchow-Thonke S, Spronk HM, Prochaska JH, Arnold N, Lackner KJ, Gori T, Ten Cate H, Munzel T, Wild PS, Panova-Noeva M. The impact of platelet indices on clinical outcome in heart failure: results from the MyoVasc study. ESC Heart Fail. 2021 Aug;8(4):2991-3001. doi: 10.1002/ehf2.13390. Epub 2021 May 3. |
| 30604046 | Background | Eggebrecht L, Prochaska JH, Trobs SO, Schwuchow-Thonke S, Gobel S, Diestelmeier S, Schulz A, Arnold N, Panova-Noeva M, Koeck T, Rapp S, Gori T, Lackner KJ, Ten Cate H, Munzel T, Wild PS. Direct oral anticoagulants and vitamin K antagonists are linked to differential profiles of cardiac function and lipid metabolism. Clin Res Cardiol. 2019 Jul;108(7):787-796. doi: 10.1007/s00392-018-1408-y. Epub 2019 Jan 2. |
| 34387673 | Background | Prochaska JH, Arnold N, Falcke A, Kopp S, Schulz A, Buch G, Moll S, Panova-Noeva M, Junger C, Eggebrecht L, Pfeiffer N, Beutel M, Binder H, Grabbe S, Lackner KJ, Ten Cate-Hoek A, Espinola-Klein C, Munzel T, Wild PS. Chronic venous insufficiency, cardiovascular disease, and mortality: a population study. Eur Heart J. 2021 Oct 21;42(40):4157-4165. doi: 10.1093/eurheartj/ehab495. |
| 37422841 | Background | Zeid S, Buch G, Velmeden D, Sohne J, Schulz A, Schuch A, Trobs SO, Heidorn MW, Muller F, Strauch K, Coboeken K, Lackner KJ, Gori T, Munzel T, Prochaska JH, Wild PS. Heart rate variability: reference values and role for clinical profile and mortality in individuals with heart failure. Clin Res Cardiol. 2024 Sep;113(9):1317-1330. doi: 10.1007/s00392-023-02248-7. Epub 2023 Jul 9. |
| 34416218 | Background | Heidorn MW, Steck S, Muller F, Trobs SO, Buch G, Schulz A, Schwuchow-Thonke S, Schuch A, Strauch K, Schmidtmann I, Lackner KJ, Gori T, Munzel T, Wild PS, Prochaska JH. FEV1 Predicts Cardiac Status and Outcome in Chronic Heart Failure. Chest. 2022 Jan;161(1):179-189. doi: 10.1016/j.chest.2021.07.2176. Epub 2021 Aug 17. |
| 34402876 | Derived | Gobel S, Prochaska JH, Trobs SO, Panova-Noeva M, Espinola-Klein C, Michal M, Lackner KJ, Gori T, Munzel T, Wild PS. Rationale, design and baseline characteristics of the MyoVasc study: A prospective cohort study investigating development and progression of heart failure. Eur J Prev Cardiol. 2021 Aug 9;28(9):1009-1018. doi: 10.1177/2047487320926438. Epub 2020 May 14. |