Centre for Cardiology - Cardiology I, University Medical Centre of the Johannes Gutenberg University Mainz, Germany.
German Centre for Cardiovascular Research (DZHK), partner site Rhine-Main, Germany.
Eur J Prev Cardiol. 2021 Aug 9;28(9):1009-1018. doi: 10.1177/2047487320926438. Epub 2020 May 14.
Heart failure (HF) is a poly-aetiological syndrome with large heterogeneity regarding clinical presentation, pathophysiology, clinical outcome and response to therapy. The MyoVasc study (NCT04064450) is an epidemiological cohort study investigating the development and progression of HF.
The primary objective of the study is (a) to improve the understanding of the pathomechanisms of HF across the full spectrum of clinical presentation, (b) to investigate the current clinical classifications of HF, and (c) to identify and characterize homogeneous subgroups regarding disease development using a systems-oriented approach. Worsening of HF, that is, the composite of transition from asymptomatic to symptomatic HF, hospitalization due to HF, or cardiac death, was defined as the primary endpoint of the study. During a six-year follow-up period, all study participants receive a highly standardized, biannual five-hour examination in a dedicated study centre, including detailed cardiovascular phenotyping and biobanking of various biomaterials. Annual follow-up examinations are conducted by computer-assisted telephone interviews recording comprehensively the participants´ health status, including subsequent validation and adjudication of adverse events.
In total, 3289 study participants (age range: 35 to 84 years; female sex: 36.8%) including the full range of HF stages were enrolled from 2013 to 2018. Approximately half of the subjects (n=1741) presented at baseline with symptomatic HF (i.e. HF stage C/D). Among these, HF with preserved ejection fraction was the most frequent phenotype.
By providing a large-scale, multi-dimensional biodatabase with sequential, comprehensive medical-technical (sub)clinical phenotyping and multi-omics characterization (i.e. genome, transcriptome, proteome, lipidome, metabolome and exposome), the MyoVasc study will help to advance our knowledge about the heterogeneous HF syndrome by a systems-oriented biomedicine approach.
ClinicalTrials.gov; NCT04064450.
心力衰竭（HF）是一种多病因综合征，在临床表现、病理生理学、临床结局和治疗反应方面存在很大的异质性。MyoVasc 研究（NCT04064450）是一项流行病学队列研究，旨在调查心力衰竭的发生和进展。
该研究的主要目的是（a）提高对全谱临床表现的心力衰竭发病机制的认识，（b）研究心力衰竭的现行临床分类，以及（c）使用系统导向的方法确定和描述疾病发展方面的同质亚组。心力衰竭恶化，即无症状向有症状心力衰竭的转变、因心力衰竭住院或心脏性死亡的综合，被定义为该研究的主要终点。在六年的随访期间，所有研究参与者在专门的研究中心接受高度标准化的每两年一次的五小时检查，包括详细的心血管表型和各种生物材料的生物库。通过计算机辅助的电话访谈每年进行随访检查，全面记录参与者的健康状况，包括随后对不良事件的验证和裁决。
共有 3289 名研究参与者（年龄范围：35 至 84 岁；女性：36.8%）于 2013 年至 2018 年期间被纳入研究，包括心力衰竭的所有阶段。约一半的受试者（n=1741）在基线时出现有症状的心力衰竭（即心力衰竭 C/D 期）。其中，射血分数保留型心力衰竭是最常见的表型。
通过提供一个大规模的、多维的生物数据库，该数据库具有连续的、全面的医学技术（亚）临床表型和多组学特征（即基因组、转录组、蛋白质组、脂质组、代谢组和外显子组），MyoVasc 研究将通过系统导向的生物医学方法帮助我们提高对异质心力衰竭综合征的认识。
ClinicalTrials.gov；NCT04064450。
