Pathophysiology of Heart Failure: the Role of Arterial Stiffness and Endothelial Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Change in Arterial stiffness measured by Pulse wave velocity (PWV) using SphygmoCor
研究概览
简要总结
Heart Failure (HF) is a global condition affecting at least 26 million people worldwide. Despite advances in treatment, HF patients continue to experience poor health outcomes. This study aims to improve understanding of the role of blood vessels in people with heart failure.
The study will assess how arterial stiffness (how stiff blood vessels are) and endothelial function (how well the lining of blood vessels functions) change over time and respond to treatments received as part of routine clinical care. Blood vessel function and heart performance will be assessed at three time points:
- At baseline (when Patients are first diagnosed with heart failure).
- After completing 4 ± 2 weeks of heart-failure medicines prescribed to patients as part of their routine clinical care.
- After completion of cardiac rehabilitation program as a part of their routine clinical care.
All assessments are non-invasive.
详细描述
This study is designed as an observational pilot study involving 50 patients (age ≥ 18 years) with a new diagnosis of HF (HFpEF or HFrEF). It is sponsored by Coventry University but will take place at The Cardiology and Cardiac Rehabilitation Departments at University Hospital Coventry and Warwickshire (study site). All study assessments will be scheduled to coincide with participants' routine clinical appointments, ensuring no additional hospital visits are required solely for research purposes.
The study will involve participants attending the clinical research site for three study visits lasting approximately 1.5 hours each:
(i) Visit 1: Baseline visit- at the point of diagnosis. (ii) Visit 2: After completion of initial pharmacologic treatment for HF (usually around 4±2 weeks).
(iii) Visit 3: After completion of cardiac rehabilitation - delivered as part of standard care for HF patients (another 4±2 weeks)
The following assessments will be performed as part of this study:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female ≥ 18 years old.
- •Have a confirmed de-novo diagnosis of Heart failure with preserved ejection fraction or Heart failure with reserved ejection fraction. Common HF phenotypes (e.g., hypertension, diabetes, obesity) will be recorded as part of routine baseline data but will not influence recruitment or sampling. .
- •Have stable Heart failure in the opinion of the investigator.
- •Have ability, in the opinion of the investigator, to participate in study activities.
- •Able to provide written informed consent.
排除标准
- •• Inability to provide verbal informed consent.
- •Presenting with severe symptoms; major co-morbidity or other alternative diagnoses (e.g., malignancy, severe respiratory disease, severe mental health problem/s).
- •Recent acute coronary syndrome (within 60 days).
- •Severe physical disability preventing independence.
- •Severe renal insufficiency.
- •Pregnancy (Present or planned).
- •Life expectancy less than 12 months
结局指标
主要结局
Change in Arterial stiffness measured by Pulse wave velocity (PWV) using SphygmoCor
时间窗: Up to 12 week
Change in arterial stiffness measured using pulse wave velocity (PWV) obtained with the SphygmoCor device from baseline to completion of pharmacological treatment and cardiac rehabilitation.
Change in Endothelial Function Measured by Laser Doppler Flowmetry (LDF)
时间窗: Up to 12 weeks
Change in endothelial function measured using Laser Doppler Flowmetry from baseline to completion of pharmacological treatment and cardiac rehabilitation.
次要结局
- Change in Cardiac Output Measured Using the Cardiac Output Response to Stress (CORS) Test(Up to 12 weeks)
- Change in Voice-derived Biomarkers Obtained From Voice Recordings(Up to 12 weeks)