Condition or disease |
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Depression Aortic Stenosis |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Impact of Depression on 1-year Major Adverse Events in Patients Aged 75 or Older Who Undergo Transcatheter Aortic Valve Implantation (TAVIDEP) |
Actual Study Start Date : | June 1, 2019 |
Actual Primary Completion Date : | June 1, 2019 |
Actual Study Completion Date : | June 30, 2019 |
Effects of anti-depressant drugs prescribed in patients diagnosed with depression by a psychiatrist after a systematic. The Short Form (36) Health Survey (a 36-item, patient-reported survey of patient health).
vitality eight scaled scores (disability, physical functioning, bodily pain, general health perceptions ; physical role functioning ;emotional role functioning ; social role functioning ; mental health, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Ages Eligible for Study: | 75 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | hubert Blain, MD, PhD | University Hospital, Montpellier |
Tracking Information | |||||
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First Submitted Date | June 13, 2019 | ||||
First Posted Date | June 24, 2019 | ||||
Last Update Posted Date | November 19, 2019 | ||||
Actual Study Start Date | June 1, 2019 | ||||
Actual Primary Completion Date | June 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Number of Incidence of MACCEs [ Time Frame: 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.
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Depression and Major Adverse Events in Older Patients Who Undergo a Transcatheter Aortic Valve Implantation | ||||
Official Title | Impact of Depression on 1-year Major Adverse Events in Patients Aged 75 or Older Who Undergo Transcatheter Aortic Valve Implantation (TAVIDEP) | ||||
Brief Summary | 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. | ||||
Detailed Description |
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.). The statistical analysis plan (SAP), covering all the analyses to be performed on all data, will be written before database lock. For all collected variables, descriptive statistics will be calculated according to the level of measurement. For metric variables, a check whether the data can be assumed normally distributed will be first conducted. For normally distributed variables, mean and standard deviation will be calculated. For skewed variables, median and range will be used. In case of categorical variables group proportions and contingency tables will be prepared. A comparison of baseline parameters between patients with and without depression (age, gender, number of drugs taken, Fried's and Rockwood's frailty criteria, SPPB, TUG, HRQOL, ADL, IADL, MMSE, Clock-Drawing test, MOCA; lives alone or not) will be conducted. The incidence of MACCEs and other endpoints (mortality, hospitalization and nursing home admission rate, ADL, IADL score) at 6 and 12 months after TAVI will be compared between patients screened and treated for depression and in patients without depression. All analyses will be performed before and after adjustment for parameters distinguishing patients with confirmed depression and without depression at baseline. The efficacy of the treatment of depression started by the psychiatrist will be assessed by comparing the 15item GDS, CES-D, Lille Apathy rating scale, HRQOL at baseline and at 6 and 12 months. The AE of antidepressant drugs will be described, such as the rate of withdrawal. If the incidence of MACCEs and other outcomes is comparable in both groups of patients, the present study will provide preliminary results in order to conduct a randomized control trial to demonstrate that the systematic screening of depression and its treatment can reduce the incidence of MACCEs in patients aged 75 or older who undergo a TAVI. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients aged 75 years or older, admitted for TAVI for severe and symptomatic aortic stenosis | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Drudi LM, Ades M, Turkdogan S, Huynh C, Lauck S, Webb JG, Piazza N, Martucci G, Langlois Y, Perrault LP, Asgar AW, Labinaz M, Lamy A, Noiseux N, Peterson MD, Arora RC, Lindman BR, Bendayan M, Mancini R, Trnkus A, Kim DH, Popma JJ, Afilalo J. Association of Depression With Mortality in Older Adults Undergoing Transcatheter or Surgical Aortic Valve Replacement. JAMA Cardiol. 2018 Mar 1;3(3):191-197. doi: 10.1001/jamacardio.2017.5064. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Withdrawn | ||||
Actual Enrollment |
0 | ||||
Original Estimated Enrollment |
300 | ||||
Actual Study Completion Date | June 30, 2019 | ||||
Actual Primary Completion Date | June 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 75 Years and older (Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Not Provided | ||||
Removed Location Countries | France | ||||
Administrative Information | |||||
NCT Number | NCT03995914 | ||||
Other Study ID Numbers | RECHMPL19_0295 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | University Hospital, Montpellier | ||||
Study Sponsor | University Hospital, Montpellier | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | University Hospital, Montpellier | ||||
Verification Date | June 2019 |