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MyoVasc Study on the Development and Progression of Heart Failure

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ClinicalTrials.gov Identifier: NCT04064450
Recruitment Status : Active, not recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Philipp Wild, MD, MSc, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date August 9, 2019
First Posted Date August 22, 2019
Last Update Posted Date August 22, 2019
Actual Study Start Date January 2013
Estimated Primary Completion Date April 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2019)
Rate of Worsening of Heart Failure [ Time Frame: Assessment in annual follow-up contacts over a period of 6 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 20, 2019)
  • Rate of Cardiac death [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Cardiac death
  • Rate of Hospitalization due to heart failure [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Hospitalization due to heart failure
  • Rate of transition from asymptomatic to symptomatic heart failure [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Transition from asymptomatic to symptomatic heart failure
  • Rate of incident heart failure (i.e. incident asymptomatic or symptomatic heart failure) in controls [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Incident heart failure (i.e. incident asymptomatic or symptomatic heart failure) in controls
  • Rate of death [ Time Frame: Follow-up of vital status for 10 years ]
    Death
  • Rate of hospitalization [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Hospitalization
  • Rate of myocardial infarction [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Myocardial infarction
  • Rate of stroke or transient ischemic attack [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Stroke or transient ischemic attack
  • Rate of cardiac arrhythmia [ Time Frame: Continuous assessment throughout the follow-up of the study ]
    Cardiac arrhythmia
  • Rate of atrial fibrillation [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Atrial fibrillation
  • Rate of angina pectoris [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Angina pectoris
  • Rate of deep vein thrombosis [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Deep vein thrombosis
  • Rate of pulmonary embolism [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Pulmonary embolism
  • Rate of arterial hypertension [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Arterial hypertension
  • Rate of peripheral artery disease [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Peripheral artery disease
  • 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 and 6 years ]
    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
  • 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 and 6 years ]
    Assessed via 2D/3D transthoracic cardiac echocardiography by a trained physician
  • Rate of revascularization [ Time Frame: Assessment in annual follow-up contacts over a period of 6 years ]
    Revascularization
  • 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 and 6 years ]
    Assessed via 2D/3D transthoracic cardiac echocardiography by a trained physician
  • 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 and 6 years ]
    Assessed via 2D/3D transthoracic cardiac echocardiography by a trained physician
  • 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 and 6 years ]
    Worsening of renal function as assessed by estimated glomerular Filtration rate (eGFR) as humoral biomarker of renal function
  • Worsening of pulmonary function as assessed by FEV1 [ Time Frame: Assessment in biannual follow-up contacts in a dedicated study center after 2, 4 and 6 years ]
    Worsening of forced expiratory volume in one second (FEV1) via body plethysmography
  • 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 and 6 years ]
    Worsening of flow-mediated dilatation (FMD) and constriction (FMC) of the radial artery
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, Urine
Sampling Method Non-Probability Sample
Study Population Individuals with asymptomatic and symptomatic heart failure and Population Controls
Condition Heart Failure
Intervention Not Provided
Study Groups/Cohorts
  • Heart Failure
    Individuals with asymptomatic or symptomatic heart failure
  • Population Controls
    Individuals free of heart failure and echocardiographic cardiac dysfunction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 20, 2019)
3289
Original Actual Enrollment Same as current
Estimated Study Completion Date April 2028
Estimated Primary Completion Date April 2028   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04064450
Other Study ID Numbers 837.319.12 (8420-F)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Philipp Wild, MD, MSc, Johannes Gutenberg University Mainz
Study Sponsor Johannes Gutenberg University Mainz
Collaborators Not Provided
Investigators
Principal Investigator: Philipp S Wild, MD, MSc University Medical Center of the Johannes Gutenberg University Mainz
PRS Account Johannes Gutenberg University Mainz
Verification Date August 2019