Heart Rate Variation in Females Predicts Tilt Test Results

NCT06496074 | Active Not Recruiting DMC

• 1 other identifier: FUPiaui_tilt_test
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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%.

Conditions

Syncope, Vasovagal

Keywords

Vasovagal syncope; Tilt-table test; Heart rate variation; Blood pressure; Hemodynamics

Outcome Measures

Primary Outcomes (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).

  30 days

Secondary Outcomes (2)

• Blood pressure variation in the head-up tilt test

  30 days

• Heart rate variation in the head-up tilt test

  30 days

Study Arms (2)

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.

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.

Diagnostic Test: Head-up Tilt Test

Interventions

Head-up Tilt Test DIAGNOSTIC_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.

Negative head-up tilt test; Positive head-up tilt test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Piaui: lead

Study Sites (1)

Carlos Eduardo Batista de Lima

Teresina, Piauí, 64048-350, Brazil

Location

Related Publications (1)

• 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.

  PMID: 41219842 DERIVED

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Eduardo Batista Lima, MD, PhD

  Federal University of Piaui

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Cardiology)

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: July 2, 2024
• Primary Completion: September 2, 2024
• Study Completion: July 2, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)