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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Brazil1 site
  • Carlos Eduardo Batista de Lima

    Teresina, Piauí, 64048-350

Other trials in Brazil

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).

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 groups in NCT06496074
Study groupRoleWhat they receive
Positive head-up tilt testPatients 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 testPatients 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted11 Jul 2024
  2. Study start2 Jul 2024
  3. Primary completion2 Sep 2024
  4. Study completion2 Jul 2025 (estimated)

Resources

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)
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

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.

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