Clinical trial NCT06496074: Heart Rate Variation in Females Predicts Tilt Test Results
Official title: Sex-Specific Heart Rate Variations in Predicting Outcomes of Head-Up Tilt Tests in Syncope Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Syncope, Vasovagal
Keywords: Vasovagal syncope
Tilt-table test
Heart rate variation
Blood pressure
Hemodynamics
Lead sponsor: Federal University of Piaui
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥ 18 years old, male or female, with the presence of the inclusion criteria and without exclusion criteria, attended with a history of syncope submitted to head-up tilt test, between January 2011 and April 2015, by the Federal University of Piaui, Brazil in co-participation with the private sector including the Clinicardio and the ITACOR Hospital, specialized centers for diagnosis and treatment of the heart disease.

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 January/2011 to April/2015. 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 1.25 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 Standards/International Electrotechnical Commission (NBR/IEC) 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 18.0 for Windows).

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old
* Patients attended with a history of syncope submitted to head-up tilt test

Exclusion Criteria:

* Patients \< 18 years old
* Patients without a history of true syncope
* Patients who did not submit to head-up tilt test
* Withdrawal of the consent form at the request of the patient or guardian

Primary outcomes:
measure: Positive diagnostic correlation
timeFrame: 30 days
Secondary outcomes:
measure: Blood pressure variation in the head-up tilt test
timeFrame: 30 days
measure: Heart rate variation in the head-up tilt test
timeFrame: 30 days
Other outcomes:
Locations:
city: Teresina
country: Brazil
facility: Carlos Eduardo Batista de Lima
state: Piauí
Study officials:
affiliation: Federal University of Piaui
name: Carlos Eduardo Batista Lima, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: