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Depression and Heart Failure Disease Progression

2021年12月17日 更新者:Duke University
Heart failure is the most costly diagnosis in the Medicare population. Clinical depression is strikingly common in heart failure patients, and not only diminishes their quality of life, but also is associated with a markedly increased risk of hospitalization or death. This study is designed to further our understanding of the behavioral and biological effects of depression in patients with heart failure, so that appropriate treatments can be developed.

研究概览

地位

完全的

条件

详细说明

There are over five million Americans living with heart failure (HF), and another 670,000 new cases being diagnosed each year. HF is a characteristically unstable condition that is the most costly diagnosis in the Medicare population and is the most common cause for hospitalization. The instability of HF disease is reflected in short-term fluctuations of the HF disease biomarker, B-Type Natriuretic Peptide (BNP). Patient self-management behaviors are important for minimizing HF disease instability. Depression is often comorbid with HF, and elevated depressive symptoms are associated with a marked increase in adverse clinical outcomes. For both depressed and non-depressed HF patients, worsening depressive symptoms mark a substantially increased risk of cardiovascular hospitalization or death. Despite the risk associated with depressive symptoms, the nature of their association with a worsening HF disease trajectory and adverse clinical outcomes is poorly understood.

Converging evidence suggests that the association between depressive symptoms and accelerated HF disease progression may involve multiple behavioral and pathophysiological pathways. This study proposes an innovative, prospective bio-behavioral monitoring study of 220 HF patients that is designed to address the issue of how depressive symptoms and their bio-behavioral manifestations are implicated in worsening HF disease. Using home-monitoring biotechnology, we propose to track fluctuations in HF disease severity using biweekly assessments of BNP over a 16-week period. Symptoms of depression and HF-related health behaviors also will be assessed biweekly via concurrent monitoring. This biweekly bio-behavioral monitoring will be framed by comprehensive baseline and 4-month assessments of depression, HF disease severity, and pathophysiological mechanisms that have been related to the presence of depressive symptoms and implicated in the progression of HF disease. Clinical outcomes also will be assessed over a 5 year follow-up period. This study will create a unique data structure that will allow us to use contemporary statistical methods that will serve to elucidate causal associations between depressive symptoms, self-management health behaviors, pathophysiological processes, and HF disease progression and clinical outcomes. The study findings are expected to yield important advances in our understanding of why depressive symptoms may be particularly detrimental in the presence of HF and will help to inform the design of future clinical trials.

研究类型

观察性的

注册 (实际的)

186

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Men and women aged 21 years or older with diagnosed heart failure.

描述

Inclusion Criteria:

  • Men or women aged 21 years or older
  • Heart Failure of at least 3-months duration
  • Left ventricular Ejection Fraction (EF) ≤ 45% by left ventricular angiography, nuclear wall motion study, or echocardiography, Or
  • Preserved ejection fraction with either: Hospitalization within the previous 12 months with management of heart failure as a major component of the care provided; or Elevated natriuretic peptide level (NT-proBNP ≥ 360 pg/ml or BNP ≥ 100 pg/ml) within 6 months of enrollment.
  • Undergoing treatment with a stable medication regimen.

Exclusion Criteria:

  • Myocardial Infarction (MI), within 1 month of enrollment
  • Percutaneous Transluminal Coronary Angioplasty(PTCA), Coronary Artery Bypass Graft (CABG) within 3 month of enrollment
  • HF due to correctable cause or condition such as uncorrected primary valvular disease
  • Alcohol or drug abuse within 12 months
  • Illness such as malignancies that are associated with a life-expectancy of < 12 months
  • Current pregnancy
  • Inability to provide informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Time to Hospitalization or Death
大体时间:5 years
Time to hospitalization or death
5 years
Change in Quality of Life
大体时间:Bi-weekly of a 4-month period, 4 months, 1 year
Psychosocial measures of Quality of Life
Bi-weekly of a 4-month period, 4 months, 1 year
Change in Self-Management Behaviors
大体时间:Bi-weekly of a 4-month period, 4 months, 1 year
Health Behaviors
Bi-weekly of a 4-month period, 4 months, 1 year
Change in Heart Failure Disease Biomarkers
大体时间:Bi-weekly of a 4-month period, 4 months, 1 year
Disease Biomarkers
Bi-weekly of a 4-month period, 4 months, 1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Andrew Sherwood, PhD、Duke University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年11月1日

初级完成 (实际的)

2021年12月1日

研究完成 (实际的)

2021年12月1日

研究注册日期

首次提交

2014年4月28日

首先提交符合 QC 标准的

2014年5月2日

首次发布 (估计)

2014年5月6日

研究记录更新

最后更新发布 (实际的)

2022年1月10日

上次提交的符合 QC 标准的更新

2021年12月17日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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