慢性心不全における糖尿病・悪液質・肥満の研究デザイン論文

慢性心不全における糖尿病・悪液質・肥満に関する研究デザインの論文を紹介します。

Stephan von Haehling, Mitja Lainscak, Wolfram Doehner, Piotr Ponikowski, Giuseppe Rosano, Jens Jordan, Piotr Rozentryt, Mathias Rauchhaus, Rostislav Karpov and Vsevolod Tkachuk, et al. Diabetes mellitus, cachexia and obesity in heart failure: rationale and design of the Studies Investigating Co-morbidities Aggravating Heart Failure (SICA-HF). Journal of Cachexia, Sarcopenia and Muscle Volume 1, Number 2, 187-194, DOI: 10.1007/s13539-010-0013-3Open Access

下記のHPで全文PDFファイルで見れます。

http://www.springerlink.com/content/a47h021348vguw23/fulltext.pdf

研究デザインを紹介する論文が増えている印象があります。通常の原著論文より研究デザイン論文を読むほうが、研究デザインの学習になりますので、たまに読むことをお勧めします。人、物、金、知識、時間といった研究資源を贅沢に使えると、こんな臨床研究ができるということがわかります。そのままマネすることは絶対にできませんが、参考にはなります。

慢性心不全では糖尿病や肥満を合併していることは少なくありませんが、それらの存在は十分認識されています。一方、悪液質も合併していることが実は少なくないのですが、あまり認識されていません。そこでこの研究は、以下の6つを目的として行われます。

Objective 1: To characterise the prevalence, incidence, persistence and phenotype of obesity, cachexia and type 2 diabetes in patients with CHF

Objective 2: To describe patterns of exercise capacity and cardiorespiratory reflex control

Objective 3: To analyse body composition and its changes over time in patients with CHF and type 2 diabetes, obesity or cachexia

Objective 4: To investigate the incidence and prevalence of sleep-disordered breathing and its impact on the clinical severity in patients with CHF

Objective 5: To establish the impact of impaired vascular reactivity on impaired skeletal muscle metabolic and functional capacity, including its underlying mechanisms

Objective 6: To describe the interplay and metabolic signalling pathways between adipose tissue, skeletal muscle, the bone marrow and the heart in patients with heart failure and type 2 diabetes, obesity and cachexia

この研究のオーバービューの図を示します。1600人以上の慢性心不全患者をリクルートして4年間フォローするという大規模コホート研究です。6カ国、11センターで行うそうです。観察研究ではこのような臨床研究が理想的なモデルの1つかもしれません。数年後の原著論文が楽しみです。

Abstract
Background
Chronic heart failure (CHF) is increasing in prevalence. Patients with CHF usually have co-morbid conditions, but these have been subjected to little research and consequently there is a paucity of guidance on how to manage them. Obesity and diabetes mellitus are common antecedents of CHF and often complicate management and influence outcome. Cachexia is an ominous and often missed sign in patients with CHF.
Methods
This manuscript describes the rationale and the design of Studies Investigating Co-morbidities Aggravating Heart Failure (SICA-HF), a prospective, multicentre, multinational, longitudinal, pathophysiological evaluation study, which is being conducted in 11 centres across six countries in the European Union and in Russia. We aim to recruit >1,600 patients with CHF due to various common aetiologies, irrespective of left ventricular ejection fraction, and with or without co-morbidities at study entry. In addition, >300 patients with type 2 diabetes mellitus without CHF and >150 healthy subjects will serve as control groups. Participants will be systematically investigated at annual intervals for up to 48 months. Additional investigations focusing on cellular and subcellular mechanisms, adipose and skeletal muscle tissue, and in endothelial progenitor cells will be performed in selected subgroups.
Conclusions
SICA-HF will provide insights into common co-morbidities in CHF with a specific emphasis on diabetes mellitus and body mass. This will provide a more thorough pathophysiological understanding of the complexity of CHF that will help develop therapies tailored to manage specific co-morbidities.