Impact of Depression on 1-year Major Adverse Events in Patients Aged 75 or Older Who Undergo Transcatheter Aortic Valve Implantation (TAVIDEP)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of Incidence of MACCEs
研究概览
简要总结
Depression, screened using the Geriatric Depression Scale (GDS) Short Form, has recently been found to be associated with a 3-fold increase in 1-year mortality after aortic valve replacement (AVR) in patients aged 70 or older. The main objective of the study is to evaluate whether the 1-year incidence of major adverse cardiac and cerebrovascular events (MACCEs), evaluated according to the valve academic research consortium 2 (VARC-2 criteria), in patients aged 75 or older who undergo a transcatheter aortic valve implantation (TAVI), should be similar in patients with depression systematically screened (using the 15-item GDS score), confirmed, and handled by a psychiatrist, and in patients without depression detected, after adjusting for frailty criteria and comorbidities.
详细描述
- Setting: the University hospital of Montpellier and the Perpignan hospital (France)
- Study population: 300 patients undergoing a TAVI, recruited over a 2-year period and followed for 12 months.
- Measurements at baseline: depression systematically screened by the 15-item Geriatric Depression Scale before TAVI. If the score is 4 or higher, patients will be evaluated by a psychiatrist and the patient will be treated according to current guidelines. Other possible confounders of the relationship between depression and poor outcomes: age; Fried's frailty phenotype; short physical performance battery; comorbidities; disability in the activities of daily living (ADL) and instrumental activities of daily living (IADL); cognitive function (Mini Mental State Examination; Clock Test score; Montreal cognitive assessment).
- Measurements (by telephone): 30 days after TAVI: MACCEs and hospitalization stay duration; 6 and 12 months after TAVI: MACCEs, 15-item GDS, ADL and IADL, new medical problem since the last visit, hospital admission, death, compliance and adverse effects of antidepressant drugs if applicable.
In case of withdrawal, the investigator will perform all examinations scheduled for the final study visit, which includes recording of AEs. In any case, the patient will be treated in accordance with standard care in the Montpellier and Perpignan centers.
Our hypothesis is that 40% of patients aged 75 or older will meet the criteria for depression (1-2), and that the 12-month incidence of MACCEs will be of 25% in patients without depression and of 50% in patients with depression. Our assumption is that the treatment of depression will reduce by 50% the incidence of MACCEs, to reach comparable incidence (relative difference of 10% or less) as the incidence observed in patients without depression.
To test this hypothesis, the number of patients with depression is 110 and the number of patients without depression is 165 (Total: 275 patients) to have a power of 90%. Considering a loss to follow-up rate of 10%, 300 patients will be included in the present study.
-Population analysis : The data will be entered into an eCRF (Ennov clinical) allowing consistencies control and remote monitoring. The data will also be validated on site from the source data by the TEC of the study. All included subjects will be taken into account in the description of the population. Data will be analyzed under the responsibility of Marie-Christine PICOT (Epidemiology and clinical research unit of the Montpellier University Hospital) with SAS software version 9 (SAS Institute, Cary, N.C.).
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 75 years or older
- •Patients eligible for TAVI and for study inclusion after a consensus decision of a multidisciplinary team including at least an interventional cardiologist, a cardiothoracic surgeon, a geriatrician, and an anesthetist.
- •Subjects able to attend all scheduled visits and to comply with all trial procedures
- •Subjects covered by public health insurance
- •Signed informed
排除标准
- •Subject unable to read or/and write
- •Patients with emergency procedure, clinical instability (defined as unstable vital signs or refractory ongoing symptoms, acute decompensated heart failure)
- •Patients with severe neuropsychiatric impairment
- •Planned longer stay outside the region that prevents compliance with the visit plan
- •Subject who are in a dependency or employment with the sponsor or the investigator
- •Participation in another clinical trial within the last 4 weeks before the screening date
结局指标
主要结局
Number of Incidence of MACCEs
时间窗: 1 year
Incidence of MACCEs (VARC-2 criteria) 12 months after a TAVI in patients aged 75 or older with or without depression screened using 15-item GDS and confirmed and handled by a psychiatrist.
次要结局
- Number of Incidence of MACCEs(1 and 6 months)
- Number of Death(6 and 12 months)
- Number of hospitalization(6 and 12 months)
- Katz Index of Independence in Activities of Daily Living(6 and 12 months)
- The Lawton Instrumental Activities of Daily Living (IADL) Scale(6 and 12 months)
- Rate of depression(1, 6 and 12 months)
- Compliance of anti-depressant drugs prescribed(1, 6 and 12 months)
- Effects of anti-depressant drugs prescribed on the Health(1, 6 and 12 months)