Clinical trial NCT04064450: MyoVasc Study on the Development and Progression of Heart Failure
Official title: MyoVasc - An Epidemiological Cohort Study to Investigate the Development and Progression of Heart Failure and the Interaction With Vascular Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure
Keywords: Heart Failure
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 3289
Sex: ALL
Minimum age (years): 35
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with asymptomatic and symptomatic heart failure and Population Controls

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Worsening of Heart Failure
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
Secondary outcomes:
measure: Incidence of Cardiac death
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of Hospitalization due to heart failure
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of transition from asymptomatic to symptomatic heart failure
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of heart failure (i.e. incident asymptomatic or symptomatic heart failure) in controls
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of death
timeFrame: Follow-up of vital status for 10 years
measure: Incidence of hospitalization
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of myocardial infarction
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of stroke or transient ischemic attack
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of cardiac arrhythmia
timeFrame: Continuous assessment throughout the follow-up of the study
measure: Incidence of atrial fibrillation
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of angina pectoris
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of deep vein thrombosis
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of pulmonary embolism
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of arterial hypertension
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Incidence of peripheral artery disease
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Worsening of exercise capacity as assessed via peak oxygen uptake
timeFrame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
measure: Worsening of systolic cardiac function assessed by ventricular ejection fraction
timeFrame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
measure: Incidence of revascularization
timeFrame: Assessment in annual follow-up contacts over a period of 10 years
measure: Worsening of diastolic cardiac function assessed by mitral inflow signal and tissue doppler of the heart
timeFrame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6 and 8 years
measure: Worsening of cardiac strain assessed by speckle-tracking of the heart
timeFrame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
measure: Worsening of renal function as assessed by glomerular filtration rate
timeFrame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
measure: Worsening of pulmonary function as assessed by FEV1
timeFrame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
measure: Worsening of vascular function as assessed by FMD/FMC
timeFrame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg-University Mainz
state: Rhineland-Palatinate
Study officials:
affiliation: University Medical Center of the Johannes Gutenberg University Mainz
name: Philipp S Wild, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.