Heart FailureNCT04064450
MyoVasc Study on the Development and Progression of Heart Failure
An observational study of Heart Failure, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 3,289 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with asymptomatic and symptomatic heart failure and Population Controls
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure | Individuals with asymptomatic or symptomatic heart failure | |
| Population Controls | Individuals free of heart failure and echocardiographic cardiac dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessment in annual follow-up contacts over a period of 10 years
Secondary outcomes (23)
Incidence of Cardiac death
Cardiac death
Measured: Assessment in annual follow-up contacts over a period of 10 years
Incidence of Hospitalization due to heart failure
Hospitalization due to heart failure
Measured: 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
Measured: 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
Measured: Assessment in annual follow-up contacts over a period of 10 years
Incidence of death
Death
Measured: Follow-up of vital status for 10 years
Incidence of hospitalization
Hospitalization
Measured: Assessment in annual follow-up contacts over a period of 10 years
Incidence of myocardial infarction
Myocardial infarction
Measured: Assessment in annual follow-up contacts over a period of 10 years
Incidence of stroke or transient ischemic attack
Stroke or transient ischemic attack
Measured: Assessment in annual follow-up contacts over a period of 10 years
Incidence of cardiac arrhythmia
Cardiac arrhythmia
Measured: Continuous assessment throughout the follow-up of the study
Incidence of atrial fibrillation
Atrial fibrillation
Measured: Assessment in annual follow-up contacts over a period of 10 years
Incidence of angina pectoris
Angina pectoris
Measured: Assessment in annual follow-up contacts over a period of 10 years
Incidence of deep vein thrombosis
Deep vein thrombosis
Measured: Assessment in annual follow-up contacts over a period of 10 years
Incidence of pulmonary embolism
Pulmonary embolism
Measured: Assessment in annual follow-up contacts over a period of 10 years
Incidence of arterial hypertension
Arterial hypertension
Measured: Assessment in annual follow-up contacts over a period of 10 years
Incidence of peripheral artery disease
Peripheral artery disease
Measured: 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
Measured: 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
Measured: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
Incidence of revascularization
Revascularization
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study startJan 2013
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Wild, MD, MSc, Johannes Gutenberg University Mainz
- Investigators
- Philipp S Wild, MD, MSc, Principal investigator, University Medical Center of the Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064450
- Sponsor's protocol ID
- 837.319.12 (8420-F)
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2019
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33533883Dahlen 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.
PubMed 33939298Eggebrecht 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.
PubMed 30604046Prochaska 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.
PubMed 34387673Zeid 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.
PubMed 37422841Heidorn 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.
PubMed 34416218Mohr M, Zeid S, Buch G, Rausch F, Velmeden D, Kazemi-Asrar F, Fooss B, Lackner KJ, Gori T, Lurz P, Prochaska JH, Hardt R, Wild PS. Age-related differences in the intake of heart failure therapy among participants from the MyoVasc study. Eur Geriatr Med. 2026 Jul 14. doi: 10.1007/s41999-026-01553-4. Online ahead of print.
PubMed 42446811Gobel 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.
PubMed 34402876
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyoVasc - An Epidemiological Cohort Study to Investigate the Development and Progression of Heart Failure and the Interaction With Vascular Disease
- ClinicalTrials.gov ID
- NCT04064450
- Acronym / sponsor ID
- 837.319.12 (8420-F)
- Conditions
- Heart Failure
- Keywords
- Heart Failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,289 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | – | –Individuals with asymptomatic or symptomatic heart failure |
| Population Controls | – | –Individuals free of heart failure and echocardiographic cardiac dysfunction |
Who may qualify
- Ages
- 35 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with asymptomatic and symptomatic heart failure and Population Controls
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Worsening of Heart Failure
Time frame: 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
23 secondary outcomes
Incidence of Cardiac death
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of Hospitalization due to heart failure
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of transition from asymptomatic to symptomatic heart failure
Time frame: 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
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of death
Time frame: Follow-up of vital status for 10 years
Incidence of hospitalization
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of myocardial infarction
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of stroke or transient ischemic attack
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of cardiac arrhythmia
Time frame: Continuous assessment throughout the follow-up of the study
Incidence of atrial fibrillation
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of angina pectoris
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of deep vein thrombosis
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of pulmonary embolism
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of arterial hypertension
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Incidence of peripheral artery disease
Time frame: Assessment in annual follow-up contacts over a period of 10 years
Worsening of exercise capacity as assessed via peak oxygen uptake
Time frame: 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
Time frame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
Incidence of revascularization
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4, 6, 8 and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 33533883Trobs 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.
- Background: PubMed 33939298Dahlen 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.
- Background: PubMed 30604046Eggebrecht 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.
- Background: PubMed 34387673Prochaska 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.
- Background: PubMed 37422841Zeid 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.
- Background: PubMed 34416218Heidorn 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.
- Derived from this study: PubMed 42446811Mohr M, Zeid S, Buch G, Rausch F, Velmeden D, Kazemi-Asrar F, Fooss B, Lackner KJ, Gori T, Lurz P, Prochaska JH, Hardt R, Wild PS. Age-related differences in the intake of heart failure therapy among participants from the MyoVasc study. Eur Geriatr Med. 2026 Jul 14. doi: 10.1007/s41999-026-01553-4. Online ahead of print.
- Derived from this study: PubMed 34402876Gobel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp S Wild, MD, MSc principal investigator
University Medical Center of the Johannes Gutenberg University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Worsening of Heart Failure (time frame: Assessment in annual follow-up contacts over a period of 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04064450, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.