MAgna GraecIa Evaluation of Comorbidities in Patients With Heart Failure STUDY (MAGIC-HF STUDY): Observational Study on Physiopathological, Diagnostic, Therapeutic, and Predictive Aspects of Heart Failure and Associated Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Determination of intimal media thickness
研究概览
简要总结
The MAGIC-HF STUDY project (MAgna GraecIa evaluation of Comorbidities in patients with Heart Failure STUDY), is an observational prevalence and incidence study focusing on the role that risk factors, various comorbidities, and their treatment may have on CV and non-CV outcomes in patients with all forms of HF. It also aim to assess whether comorbidities and their treatment may be predictors of response to pharmacological and non-drug treatment of HF.
详细描述
Adult subjects with all forms of HF (HFrEF, HFmrEf, HEpEF) with at least one comorbidity who are referred to the Heart Failure Outpatient Clinic of the AOU "Mater Domini" Geriatrics Unit in Catanzaro will be recruited.
Initially, patients will be evaluated at baseline and followed-up for a minimum of six-month.
All patients will be subjected to clinical, instrumental and laboratory examinations, including medical history data collection and complete anthropometric assessment . Plasma and serum samples will be collected at recruitment and at the six-months follow-up visit. Stool samples will also be obtained and stored at -80C for the omics studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed Consent obtained before performing any procedure
- •Age>18 years old
- •Confirmed diagnosis of HFrEF, HFmrEF, HFpEF with clinical stability for at least 4 weeks
- •Presence of at least one of the following comorbidities:
- •Atrial fibrillation
- •Peripheral arteriopathy
- •Hypertension
- •Chronic ischemic heart disease
- •Diabetes mellitus type 2 or insulin resistance
- •Hepatopathy
- •Sleep apnea syndrome
- •Chronic kidney disease
- •Iron deficiency
- •Cognitive Decline or Depression
- •Sarcopenia
- •Dysthyroidisms
- •Hypovitaminosis D
- •Hyperuricemia
排除标准
- •Liver cirrhosis Child-Pugh C
- •Severe chronic renal failure defined by an estimated glomerular filtration rate (eGFR) value < 15 ml/min/1.73 m2 according to CKD-EPI
- •Suspected alcohol or drug abuse
- •Pregnancy or breast feeding
结局指标
主要结局
Determination of intimal media thickness
时间窗: 6 months
Determination of intimal media thickness by high-resolution ultrasonography of common carotid arteries
Evaluation of autonomy in daily activities
时间窗: 6 months
Geriatric multidimensional assessment for the evaluation of autonomy in daily activities living (ADL) in patients over 65 years old. The score ranges from 0/6 (maximum dependence) to 6/6 (maximum autonomy).
Sarcopenia
时间窗: 6 months
Geriatric multidimensional assessment for the evaluation of Sarcopenia by SARC-f questionnaire in patients over 65 years old. Score Range 0-10 points.
Evaluation of cardiac parameters
时间窗: 6 months
Echocardiographic evaluation of the left ventricular global system, left ventricular ejection fraction, left atrial diameter, cardiac output, cardiac index, right ventricular global function by Color-Doppler echocardiogram (Vivid E95, GE Healthcare, Horten, Norway)
Spekle-tracking Imaging
时间窗: 6 months
A 2D speckle tracking analysis was retrospectively performed using vendor-specific 2D speckle tracking software (EchoPAC PC, version 113.0.5, GE Healthcare, Horten, Norway). Manual tracings of the endocardial border during end-systole in three apical views was performed to evaluate GLS. echocardiogram (Vivid E95, GE Healthcare, Horten, Norway)
Montreal Cognitive Assessment
时间窗: 6 months
Geriatric multidimensional assessment for the evaluation of Montreal Cognitive Assessment (MoCA) in patients over 65 years old. This one-page 30-point test can be administered to the patient in at last 10 min. Cut-off score 26 points.
MiniMental State examination
时间窗: 6 months
Geriatric multidimensional assessment for the evaluation of MiniMental State examination (MMSE), in patients over 65 years old (range values 0-30 score).
Geriatric depression scale
时间窗: 6 months
Geriatric multidimensional assessment for the evaluation of Geriatric depression scale (GDS) in patients over 65 years old. The short form (GDS-S) consists of 15 items. Of the 15 elements, 10 indicate the presence of depression when responding positively, while the other five are indicative of depression when responding negatively, moreover \> 5 points suggest depression and require follow-up evaluation, ≥ 10 points almost always indicates depression.
Autonomy in instrumental activities of daily living
时间窗: 6 months
Geriatric multidimensional assessment for the evaluation of autonomy in instrumental activities of daily living (IADL) in patients over 65 years old. Range values 0-8 points.
Short Performance Physical battery
时间窗: 6 months
Geriatric multidimensional assessment for the evaluation of Short Performance Physical battery (SPPB) in patients over 65 years old. The total score of the scale has a range from 0 to 12 minutes.
Assessment of endothelial function
时间窗: 6 months
Evaluation of endothelial function by Digital semiplethysmographic method through EndoPAT
Pulse Wave velocity assessment
时间窗: 6 months
Evaluation of carotid-femoral pulse wave velocity by SphygmoCor
Determination of lipopolysaccharide
时间窗: 6 months
Evaluation of lipopolysaccharide by ELISA sandwich
次要结局
- Study of functional gut microbiota(6 months)
- Evaluation of gut microbiota(6 months)
- Evaluation of platelets activation(6 months)
- Evaluation of endocan levels(6 months)
- Evaluation of hepcidin(6 months)
- Determination of mammalian target of rapamycin (mTOR)(6 months)
- Proteomic analysis(6 months)
- Evaluation of oxidative stress(6 months)
- Evaluation of inflammatory cytokines(6 months)
研究者
Angela Sciacqua
Associate Professor
University of Catanzaro