Ignite Creation Date:
2024-07-17 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496074
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-03
Brief Title:
Heart Rate Variation in Females Predicts Tilt Test Results
Sponsor:
Federal University of Piaui
Organization:
Federal University of Piaui
Study Overview
Official Title:
Sex-Specific Heart Rate Variations in Predicting Outcomes of Head-Up Tilt Tests in Syncope Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
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:
Head-up tilt test HUTT is widely used to evaluate patients with unexplained syncope but data on clinical predictors of HUTT results are limited The investigators aim to evaluate heart rate HR variations and blood pressure BP changes associated with the HUTT results and the difference according to the gender For this a cross-sectional study will be performed with patients attended with unexplained syncope submitted to HUTT 70-degree angle from January2011 to April2015 The investigators will analyze BP changes and Receiver-Operating Characteristics ROC curves for the maximum interval in HR variation from the first minute to tenth minute delta-HR 10 after tilting The significance level will be considered at 5
Detailed Description:
The protocols for the HUTT are passive or prolonged inclination protocol 40 minutes and mixed protocol passive phase first 20 minutes plus nitrate-provoked phase last 20 minutes with the use of 125 mg sublingual isosorbide dinitrate Blood pressure BP measurements will be obtained manually with the Welch Allyn DS44-11BR Durashock sphygmomanometer and heart rate HR data will be obtained continuously by cardiac monitoring in a conventional 12-lead ECG-PC TEB surface electrocardiogram with automatic measurements certified by Brazilian National StandardsInternational Electrotechnical Commission NBRIEC 60601-2-51 and registration number with Brazilian Health Regulatory Agency ANVISA 10265690026 All patients will be submitted to 10 minutes of rest in the supine position at zero degree before the tilt phase of the HUTT During this period HR and systolic SBP and diastolic DBP measurements will be obtained every 2 minutes After this phase the table is tilted at an angle of 70 with measurement of SBP DBP and HR every minute Patients older than 60 years are routinely investigated for carotid sinus hypersensitivity by carotid sinus massage during the passive phase of the HUTT The exam is considered positive according to the criteria defined in guidelines The variables analyzed are age sex symptoms prior to examination including syncope near-syncope and others including dizziness palpitations and suspected dysautonomia The maximum heart rate HR interval variations present from the rest phase up to the first minute HR Delta 1min and from the first minute up to the tenth minute HR Delta 10min in tilt phase are documented The interval changes in systolic and diastolic blood pressure measurements are obtained from the last measurement of the rest phase up to the first minute in tilt phase For statistical analysis the Chi-square test will be used to verify the dependence or independence of variables considered by evaluating the association between qualitative variables The t-Student test will be used to evaluate the differences between the means of the two groups The Mann-Whitney test Wilcoxon rank-sum test will be used to compare two unpaired groups verifying whether or not they belong to the same population and whose requirements for applying the t-student test are not met For the definition of the cutoff points of variations in HR the ROC curves will be constructed for the HR delta 1 min and HR delta 10 min variables evaluating the performance of these parameters and analyzing the sensitivity and specificity for their correlation with the positivity in the HUTT Through the logistic regression model the probability curves will be constructed for the HUTT positivity for the parameters of HR delta 1 min and HR delta 10 min and for the non-positivity in the HUTT in relation to the BP variation up to the second minute of the examination The significance level will be considered at 5 Statistical analysis will be performed using the Statistical Package for the Social Sciences SPSS version 180 for Windows
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None