Ignite Creation Date:
2024-05-06 @ 4:33 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05024942
Status:
UNKNOWN
Last Update Posted:
2021-08-27
First Post:
2021-08-10
Brief Title:
LUS in Aortic Stenosis Patients Undergoing TAVR
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
Lung Ultrasound in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Replacement a Prospective Study
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Introduction and aims
Transcatheter aortic valve replacement TAVR is the gold standard for the treatment of elderly patients with severe aortic valve stenosis AS AS causes left ventricular remodeling as well as left atrial enlargement pulmonary artery and right ventricular changes these changes and whether they are reversible reverse remodeling are major determinants of outcome after TAVR Heart Failure HF is the most frequent cause of cardiac re-hospitalization after TAVR Most HF exacerbations are related to a progressive rise in cardiac filling pressures that precipitates pulmonary congestion and symptomatic decompensation Traditionally pulmonary congestion has been assessed by physical examination and chest radiography but clinical signs and symptoms of congestion are poor surrogates for ventricular filling pressures and are not reliable predictors of imminent hospitalization Recently lung ultrasonography LUS has been identified as a sensitive and semi-quantitative tool for the assessment of pulmonary congestion in HF The technique is based on the detection of vertical echogenic artifacts arising from the pleural line named B-lines The number of B-lines is associated with increased risk of adverse events during hospitalization and after hospital discharge CLUSTER-HF Trial demonstrated that the routine incorporation of LUS during clinical follow-up of patients with recent acute decompensated HF without a surgically correctable cause was associated with a risk reduction of adverse HF events mainly urgent HF visits
Thus LUS could represent a promising tool to detect pulmonary congestion related to AS To date there are no studies on the role of LUS in the context of AS and TAVR
The study hypothesis is that in patients with higher number of B-lines before-TAVR and after TAVR the rate of adverse events during follow-up is higher
2 Study design
This is a single center prospective study carried out at Fondazione Policlinico Gemelli IRCCS Roma and involving patients with severe aortic stenosis submitted to TAVR treatment The expected recruitment period is approximately one year For patients fulfilling inclusionexclusion criteria all data about clinical status leading to TAVR exams and any specific documentation during hospitalization will be collected
3 Number of patients
For the primary end-point a sample-size of 91 is computed using the one-sample chi-square test and assuming a proportion of LUS-evaluated pulmonary congested patients before TAVR of 50 and a proportion of 35 of LUS-evaluated pulmonary congested patients after TAVR To accommodate for possible missing investigations sample size will be increased to 105 patients
The secondary end-point is the association between pre-TAVR and post-TAVR B-lines and long-term outcomes Based on previous studies the investigators know that the incidence of rehospitalization for heart failure during one-year after TAVR is 14 and that patients suffering from heart failure without LUS-evaluated pulmonary congestion are at very low risk of heart failure rehospitalization during follow-up So for sample size calculation of the secondary endpoint the investigators estimated a cumulative incidence higher in the LUS- evaluated pulmonary congestion group with more than 16 B-lines on all scanning sites 30 of events during 1-year of follow-up with a lower incidence of 8 in the remaining patients With an HR of 5 favoring patients wit less than 15 B-Lines on all scanning and aiming to a 2-sided alpha level of 005 and a power of 80 the investigators estimated 144 patients To accommodate for possible missing investigations sample size will be increased to 150 patients
4 In-hospital study schedule
For each patient the investigators will obtain from our general hospital database the following clinical data
Demographic and clinical data documentation
Clinical examination before TAVR before discharge and when adverse events occur
Blood analysis
TAVR procedural characteristics and complications
5 Instrumental diagnostic exams Echocardiography and lung ultrasound
Each patient will be evaluated before and after TAVR with a comprehensive echocardiogram and LUS for the evaluation of the pulmonary congestion All the evaluations will be performed the day before TAVR and after TAVR
In consideration of the operators dependence on ultrasound methods to reduce the error rate all examinations will be performed by qualified personnel
6 Clinical follow up assessment
Clinical follow up information will be obtained from visits review of the patients hospital record personal communication with the patients physician and review of the patients chart a telephone interview with the patient conducted by trained medical personnel The following information will be recorded clinical status assessment adverse event assessment record cardiac medications
Transcatheter aortic valve replacement TAVR is the gold standard for the treatment of elderly patients with severe aortic valve stenosis AS AS causes left ventricular remodeling as well as left atrial enlargement pulmonary artery and right ventricular changes these changes and whether they are reversible reverse remodeling are major determinants of outcome after TAVR Heart Failure HF is the most frequent cause of cardiac re-hospitalization after TAVR Most HF exacerbations are related to a progressive rise in cardiac filling pressures that precipitates pulmonary congestion and symptomatic decompensation Traditionally pulmonary congestion has been assessed by physical examination and chest radiography but clinical signs and symptoms of congestion are poor surrogates for ventricular filling pressures and are not reliable predictors of imminent hospitalization Recently lung ultrasonography LUS has been identified as a sensitive and semi-quantitative tool for the assessment of pulmonary congestion in HF The technique is based on the detection of vertical echogenic artifacts arising from the pleural line named B-lines The number of B-lines is associated with increased risk of adverse events during hospitalization and after hospital discharge CLUSTER-HF Trial demonstrated that the routine incorporation of LUS during clinical follow-up of patients with recent acute decompensated HF without a surgically correctable cause was associated with a risk reduction of adverse HF events mainly urgent HF visits
Thus LUS could represent a promising tool to detect pulmonary congestion related to AS To date there are no studies on the role of LUS in the context of AS and TAVR
The study hypothesis is that in patients with higher number of B-lines before-TAVR and after TAVR the rate of adverse events during follow-up is higher
2 Study design
This is a single center prospective study carried out at Fondazione Policlinico Gemelli IRCCS Roma and involving patients with severe aortic stenosis submitted to TAVR treatment The expected recruitment period is approximately one year For patients fulfilling inclusionexclusion criteria all data about clinical status leading to TAVR exams and any specific documentation during hospitalization will be collected
3 Number of patients
For the primary end-point a sample-size of 91 is computed using the one-sample chi-square test and assuming a proportion of LUS-evaluated pulmonary congested patients before TAVR of 50 and a proportion of 35 of LUS-evaluated pulmonary congested patients after TAVR To accommodate for possible missing investigations sample size will be increased to 105 patients
The secondary end-point is the association between pre-TAVR and post-TAVR B-lines and long-term outcomes Based on previous studies the investigators know that the incidence of rehospitalization for heart failure during one-year after TAVR is 14 and that patients suffering from heart failure without LUS-evaluated pulmonary congestion are at very low risk of heart failure rehospitalization during follow-up So for sample size calculation of the secondary endpoint the investigators estimated a cumulative incidence higher in the LUS- evaluated pulmonary congestion group with more than 16 B-lines on all scanning sites 30 of events during 1-year of follow-up with a lower incidence of 8 in the remaining patients With an HR of 5 favoring patients wit less than 15 B-Lines on all scanning and aiming to a 2-sided alpha level of 005 and a power of 80 the investigators estimated 144 patients To accommodate for possible missing investigations sample size will be increased to 150 patients
4 In-hospital study schedule
For each patient the investigators will obtain from our general hospital database the following clinical data
Demographic and clinical data documentation
Clinical examination before TAVR before discharge and when adverse events occur
Blood analysis
TAVR procedural characteristics and complications
5 Instrumental diagnostic exams Echocardiography and lung ultrasound
Each patient will be evaluated before and after TAVR with a comprehensive echocardiogram and LUS for the evaluation of the pulmonary congestion All the evaluations will be performed the day before TAVR and after TAVR
In consideration of the operators dependence on ultrasound methods to reduce the error rate all examinations will be performed by qualified personnel
6 Clinical follow up assessment
Clinical follow up information will be obtained from visits review of the patients hospital record personal communication with the patients physician and review of the patients chart a telephone interview with the patient conducted by trained medical personnel The following information will be recorded clinical status assessment adverse event assessment record cardiac medications
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None