MyoVasc Study on the Development and Progression of Heart Failure

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 3289

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • University Medical Center of the Johannes Gutenberg-University Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Individuals with asymptomatic and symptomatic heart failure and Population Controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Heart Failure; Individuals with asymptomatic or symptomatic heart failure
Population Controls; Individuals free of heart failure and echocardiographic cardiac dysfunction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Philipp S Wild, MD, MSc, University Medical Center of the Johannes Gutenberg University Mainz

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. 2023 Jul 9. doi: 10.1007/s00392-023-02248-7. Online ahead of print.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 837.319.12 (8420-F)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No