Syncope, VasovagalNCT06496074
Heart Rate Variation in Females Predicts Tilt Test Results
An observational study of Syncope, Vasovagal, run by Federal University of Piaui at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Vasovagal
- What is being tested?
- Head-up Tilt Test
- How many people
- 149 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jul 2024to 2 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients ≥ 18 years old
- Patients attended with a history of syncope submitted to head-up tilt test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sex-Specific Heart Rate Variations in Predicting Outcomes of Head-Up Tilt Tests in Syncope Patients
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%.
Read the 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).
- Conditions
- Syncope, Vasovagal
- Being tested
- Head-up Tilt Test
- Keywords
- Vasovagal syncope, Tilt-table test, Heart rate variation, Blood pressure, Hemodynamics
- Medical subject headings
- Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-up Tilt TestDiagnostic test
Two protocols for the head-up tilt test (HUTT) are used in our center and in the collaborating centers: (1) passive or prolonged inclination protocol [40 minutes], (2) mixed protocol: passive phase [first 20 minutes] plus nitrate-provoked phase [last 20 minutes], with the use of 1.25 mg sublingual isosorbide dinitrate. All patients are 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 are 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.
| Study group | Role | What they receive |
|---|---|---|
| Positive head-up tilt test | Patients who underwent to head-up tilt test (HUTT) and met criteria for positive exam according to the defined in guidelines. Receives: Diagnostic Test: Head-up Tilt Test | |
| Negative head-up tilt test | Patients who underwent to head-up tilt test (HUTT) and did not met criteria for positive exam according to the defined in guidelines. Receives: Diagnostic Test: Head-up Tilt Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive diagnostic correlation
Positive diagnostic correlation of the data obtained in group 1 (positive head-up tilt test) in relation to group 2 (negative head-up tilt test).
Measured: 30 days
Secondary outcomes (2)
Blood pressure variation in the head-up tilt test
Accuracy, sensitivity, and specificity of blood pressure values as predictors of outcome in the head-up tilt test
Measured: 30 days
Heart rate variation in the head-up tilt test
Accuracy, sensitivity, and specificity of heart rate values as predictors of outcome in the head-up tilt test
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start2 Jul 2024
- Primary completion2 Sep 2024
- Study completion2 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Syncope, VasovagalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Piaui
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Eduardo Batista de Lima, MD, PhD, Federal University of Piaui
- Investigators
- Carlos Eduardo Batista Lima, MD, PhD, Principal investigator, Federal University of Piaui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496074
- Sponsor's protocol ID
- FUPiaui_tilt_test
- Status last verified
- Sep 2024
- First submitted
- 3 Jul 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I have no plan to share individual patient data with other researchers.
Publications
de Lima CEB, da Silva PAD, de Sa Nascimento SRA, de Freitas MVA, de Area Leao Moreira FG, Silvino VO, Ramos RM, Pereira Dos Santos MA. Sex-Specific heart rate acceleration as predictors of positive head-up tilt test outcomes in syncope patients. BMC Cardiovasc Disord. 2025 Nov 11;25(1):800. doi: 10.1186/s12872-025-05290-7.
PubMed 41219842
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-Specific Heart Rate Variations in Predicting Outcomes of Head-Up Tilt Tests in Syncope Patients
- ClinicalTrials.gov ID
- NCT06496074
- Acronym / sponsor ID
- FUPiaui_tilt_test
- Conditions
- Syncope, Vasovagal
- Keywords
- Vasovagal syncope, Tilt-table test, Heart rate variation, Blood pressure, Hemodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Federal University of PiauiUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 2 Sep 2024 (actual)
- Study completion
- 2 Jul 2025 (estimated)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive head-up tilt test | – | Diagnostic Test: Head-up Tilt TestPatients who underwent to head-up tilt test (HUTT) and met criteria for positive exam according to the defined in guidelines. |
| Negative head-up tilt test | – | Diagnostic Test: Head-up Tilt TestPatients who underwent to head-up tilt test (HUTT) and did not met criteria for positive exam according to the defined in guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients ≥ 18 years old
- Patients attended with a history of syncope submitted to head-up tilt test
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head-up Tilt TestTwo protocols for the head-up tilt test (HUTT) are used in our center and in the collaborating centers: (1) passive or prolonged inclination protocol [40 minutes], (2) mixed protocol: passive phase [first 20 minutes] plus nitrate-provoked phase [last 20 minutes], with the use of 1.25 mg sublingual isosorbide dinitrate. All patients are 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 are 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. | Diagnostic test | Negative head-up tilt test, Positive head-up tilt test |
Primary outcome
Positive diagnostic correlation
Time frame: 30 days
Positive diagnostic correlation of the data obtained in group 1 (positive head-up tilt test) in relation to group 2 (negative head-up tilt test).
2 secondary outcomes
Blood pressure variation in the head-up tilt test
Time frame: 30 days
Heart rate variation in the head-up tilt test
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Derived from this study: PubMed 41219842de Lima CEB, da Silva PAD, de Sa Nascimento SRA, de Freitas MVA, de Area Leao Moreira FG, Silvino VO, Ramos RM, Pereira Dos Santos MA. Sex-Specific heart rate acceleration as predictors of positive head-up tilt test outcomes in syncope patients. BMC Cardiovasc Disord. 2025 Nov 11;25(1):800. doi: 10.1186/s12872-025-05290-7.
- Individual participant dataSharing planned: No. I have no plan to share individual patient data with other researchers.
Related trials for Syncope, Vasovagal
RecruitingObservational study
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
Syncope, Vasovagal
RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac
Recruiting
Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial
Colorectal Neoplasia, Screening Colonoscopy
Active, not recruitingObservational study
A Warning Red Flag Classification System to Predict Risk of Vasovagal Event During Office Hysteroscopy
Vasovagal Syncope (VVS), Presyncope
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Eduardo Batista Lima, MD, PhD principal investigator
Federal University of Piaui
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope, Vasovagal, run by Federal University of Piaui at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive diagnostic correlation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06496074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.