Hospital Register of Decompensated Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Amount of secondary hospitalisations
研究概览
简要总结
Study Aim is creation of the Hospital Register of patients with heart failure with preserved ejection fraction (HFpEF) for a comprehensive assessment of the influence of gender characteristics, clinical and anamnestic factors, body composition, topical characteristics of congestion, instrumental data and markers of cellular inflammation and stress on immediate and long-term outcomes in patients with acute decompensated heart failure with preserved ejection fraction.
During the study it is planned to assess gender, clinical and anamnestic indicators preceding hospitalization of patients in the hospital; characterize the features of comorbid status in the studied group of patient; study the features of drug therapy at the prehospital stage and during hospitalization in the study group of patient; assess adverse hospital outcomes and outcomes 6 months after hospital discharge and identify factors associated with them; assess body composition in patients with acute decompensated heart failure with preserved ejection fraction in obese patients upon admission to the hospital; characterize the severity and topical characteristics of congestion and compare with the phenotypes of acute decompensation of heart failure; asess adverse in-hospital outcomes and outcomes 6 months after hospital discharge and identify factors associated with them; conduct a clinical and instrumental examination of patients diagnosed with compensated and decompensated HFpEF, verified by echocardiography at rest, as well as in patients with HFpEF verified after an additional diastolic stress test with assessment of intracardiac hemodynamic; analyze the serum concentrations of biochemical markers associated with cellular stress in these groups of patients, as well as in the control group of apparently healthy people; conduct an analysis of associations of biomarker levels with clinical characteristics of patients, the presence of comorbid diseases, including obesity, as well as with data from instrumental examination methods; assess the diagnostic capabilities of HFpEF, defined by various criteria, based on the concentration of the new biomarkers The results obtained will allow us to evaluate the characteristics of the course and outcomes of the disease in Moscow patients, depending on the phenotype of acute decompensation of HFpEF, hospitalized in the hospital during the study period. It is expected to identify phenotypes of acute decompensation of HFpEF that affect the duration of hospitalization and the development of adverse outcomes in the hospital and long-term period of the disease.
详细描述
THE RELEVANCE OF RESEARCH Identifying patients with heart failure with preserved ejection fraction (HFpEF) represents a significant public health challenge. In a significant proportion of patients with HFpEF, no specific underlying etiology has been identified, with the exception of cardiovascular risk factors such as hypertension, obesity, diabetes mellitus, the presence of atrial fibrillation, and others. Many of these patients are classified as having hypertension and do not receive the necessary amount of preventive interventions aimed at reducing hospitalizations and increasing life expectancy. The incidence of hospitalization for acute decompensated heart failure is increasing, mainly due to acute HFpEF. It is hypothesized that systemic inflammation resulting from comorbidities such as obesity, diabetes mellitus, and hypertension is responsible for the pathogenesis of myocardial structural and functional changes in HFpEF. Therefore, assessment of clinical and anamnestic factors and their relationship with signs of structural changes, functional disorders of intracardiac hemodynamics, signs of congestion and systemic inflammation will help optimize the diagnostic and treatment algorithm for patients with acute decompensation of HFpEF.
In this context, additional markers such as body composition measures, ultrasound congestion criteria, and cellular stress-related biomarkers may complement or even surpass traditional markers in predicting the severity and prognosis of HFpEF.
The creation of a register and analysis of the data entered into it will help improve the comprehensive diagnosis of decompensated HFpEF
PURPOSE OF THE STUDY:
Creation of a register of patients with HFpEF for a comprehensive assessment of the influence of gender characteristics, clinical and anamnestic factors, body composition, topical characteristics of congestion, instrumental data and markers of cellular inflammation and stress on immediate and long-term outcomes in patients with acute decompensated heart failure with preserved ejection fraction.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients hospitalized with a clinical picture of acute decompensation of heart failure (shortness of breath, orthopnea, clinical signs of "cardiac asthma" and/or "pulmonary edema") in the city clinical hospital named after. V.V. Veresaeva, Moscow. Patients with a confirmed diagnosis in accordance with instrumental (EchoCG) and/or laboratory criteria.
排除标准
- •Refusal to sign informed consent to participate in a clinical trial and to process personal data.
研究组 & 干预措施
Patient with HFpEF with decompensation
120 patients hospitalized with a clinical picture of acute decompensation of heart failure (shortness of breath, orthopnea, clinical signs of "cardiac asthma" and/or "pulmonary edema") in the city clinical hospital named after. V.V. Veresaeva, Moscow. Patients with a confirmed diagnosis in accordance with instrumental and/or laboratory criteria
干预措施: Echocardiography (Diagnostic Test)
Patient with HFpEF with decompensation
120 patients hospitalized with a clinical picture of acute decompensation of heart failure (shortness of breath, orthopnea, clinical signs of "cardiac asthma" and/or "pulmonary edema") in the city clinical hospital named after. V.V. Veresaeva, Moscow. Patients with a confirmed diagnosis in accordance with instrumental and/or laboratory criteria
干预措施: Immunoassay (Diagnostic Test)
Patient with HFpEF with decompensation
120 patients hospitalized with a clinical picture of acute decompensation of heart failure (shortness of breath, orthopnea, clinical signs of "cardiac asthma" and/or "pulmonary edema") in the city clinical hospital named after. V.V. Veresaeva, Moscow. Patients with a confirmed diagnosis in accordance with instrumental and/or laboratory criteria
干预措施: Bioimpedance (Diagnostic Test)
Patient with HFpEF with decompensation
120 patients hospitalized with a clinical picture of acute decompensation of heart failure (shortness of breath, orthopnea, clinical signs of "cardiac asthma" and/or "pulmonary edema") in the city clinical hospital named after. V.V. Veresaeva, Moscow. Patients with a confirmed diagnosis in accordance with instrumental and/or laboratory criteria
干预措施: Routine biochemistry (Diagnostic Test)
Control group
40 particularly healthy people without heart failure and acute cardiovascular diseases
干预措施: Bioimpedance (Diagnostic Test)
Control group
40 particularly healthy people without heart failure and acute cardiovascular diseases
干预措施: Immunoassay (Diagnostic Test)
Control group
40 particularly healthy people without heart failure and acute cardiovascular diseases
干预措施: Routine biochemistry (Diagnostic Test)
结局指标
主要结局
Amount of secondary hospitalisations
时间窗: 6 months
Hospitalisations with decompensation of HFpEF
次要结局
- Amount of hospitalisations with acute coronary syndrome(6 months)
- Amount of hospitalisations with pulmonary embolism(6 months)
- Amount of other cardiovascular events(6 months)
- Amount of hospitalisations with stroke(6 months)