NCT04064450

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,289

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jan 2013Dec 2028

Study Start

First participant enrolled

January 1, 2013

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

15.9 years

First QC Date

August 9, 2019

Last Update Submit

August 20, 2024

Conditions

Heart Failure

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (23)

  • Incidence of Cardiac death

    Assessment in annual follow-up contacts over a period of 10 years

  • Incidence of 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

    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

    Assessment in annual follow-up contacts over a period of 10 years

  • Incidence of death

    Follow-up of vital status for 10 years

  • +18 more secondary outcomes

Study Arms (2)

Heart Failure

Individuals with asymptomatic or symptomatic heart failure

Population Controls

Individuals free of heart failure and echocardiographic cardiac dysfunction

Eligibility Criteria

Age35 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with asymptomatic and symptomatic heart failure and Population Controls

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (7)

  • 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.

    PMID: 33533883BACKGROUND

  • 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.

    PMID: 33939298BACKGROUND

  • 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.

    PMID: 30604046BACKGROUND

  • 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.

    PMID: 34387673BACKGROUND

  • 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.

    PMID: 37422841BACKGROUND

  • 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.

    PMID: 34416218BACKGROUND

  • 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.

    PMID: 34402876DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Philipp S Wild, MD, MSc

    University Medical Center of the Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. Philipp S. Wild, MD, MSc

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 22, 2019

Study Start

January 1, 2013

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)