Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04859036
  4. Details
NCT04859036 Clinical Trial

The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters

Autonomic Nervous System Imbalance Clinical Trial

Official title:
The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04859036
Other study ID # 2014/39
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2016
Est. completion date April 1, 2017

Study information
Verified date April 2021
Source Kayseri City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study; we evaluated the heart rate variability parameters of pediatric patients whose VSDs were closed with the transcatheter method before and after, and compared with the control group.

Description:

Heart rate variability (HRV) is a sign of cardiac autonomic nervous system. Evaluation of HRV in pediatric ventricular septal defect (VSD) cases before and after transcatheter closure will enlighten us in terms of cardiac autonomic control. Methods: 19 VSD cases treated with transcatheter closure method and 18 healthy children were enrolled in the study. 24 hours Holter rhythm monitorization was applied to all patients before closure of VSD and to the control group. In the patient group, Holter rhythm monitorization was repeated in the third months. HRV parameters were obtained from Cardio Scan Premier 12® program. Frequency domain (Total power, VLF, LF, HF, LF/HF ratio) and time domain analysis (SDNN, SDANN, SDNNi, pNN50, rMSSD) were applied.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date April 1, 2017
Est. primary completion date April 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 56 Months to 136 Months
Eligibility Inclusion Criteria: - VSD diameter <6mm - Significant left-to-right shunt - Left atrial and ventricular enlargement detected by echocardiography or calculation of Qp/Qs ratio above 1.5 in the catheterization laboratory (Qp/Qs>1.5) Exclusion Criteria: - Patients with arrhythmia after the procedure - Young patients who may be inconsistent during Holter records

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 24 hours ambulatory Holter monitoring

Locations
Country Name City State
Turkey Süleyman Sunkak Kayseri Kocasinan

Sponsors (1)
Lead Sponsor Collaborator
Kayseri City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. — View Citation

Narin N, Pamukcu O, Tuncay A, Baykan A, Sunkak S, Tasci O, Uzum K, Saltik L. Percutaneous Ventricular Septal Defect Closure in Patients Under 1 Year of Age. Pediatr Cardiol. 2018 Jun;39(5):1009-1015. doi: 10.1007/s00246-018-1852-5. Epub 2018 Mar 15. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Heart rate variability parameters Time Domain analysis:
After ectopic beats and artifacts were excluded, the following indices were calculated for time domian analysis in the whole Holter recording.
SDNN: Standard deviation of all filtered RR intervals
SDANN: Standard deviation of 5-minute averages of RR intervals
SDNNindex: Mean of the standard deviation of all RR intervals for all the 5-minute segments
rMSSD: Square root of the mean of the sum of square differences between adjacent filtered RR interval
PNN50: Percentage of the difference between adjacent RR intervals greater than 50 milliseconds
Frequency domain analysis:
We determined spectral power over three frequency.
Very low frequency (VLF) index (0.003-0.04 Hz)
Low frequency (LF) index (0.04 - 0.15 Hz)
High frequency (HF) index (0.15 - 0.40 Hz)
Total power: Variance of all NN intervals approximately <0.4 Hz		 24 hours
See also
  Status Clinical Trial Phase
Completed NCT03616275 - Enhancing the Vagal Tone in Prediabetes Individuals N/A
Completed NCT01736137 - Evaluation of the Six Minute Walk Test and Other Instruments in Heart Failure N/A
Completed NCT03362944 - Active and Passive Music Therapy Interventions N/A
Completed NCT04636970 - Unobtrusive Technologies for Monitoring of Autonomic Nervous System Function in Elderly Frail Patients N/A
Completed NCT03888456 - Effects of OMT on ANS: a Thermography Study N/A
Withdrawn NCT03332043 - HIRREM for Pre-Hypertension N/A
Not yet recruiting NCT03144791 - Lighting and Human Response in Motor Time, Autonomic Nervous System, and Emotion N/A
Completed NCT03244891 - Autonomic Challenges From Mild Hypovolemia and Mechanical Ventilation N/A
Recruiting NCT03955159 - Effects of Probiotic Supplementation in Hypertensive Women on Menopause N/A
Not yet recruiting NCT06217133 - Heart Rate Variability of Premature Newborn N/A
Recruiting NCT03302923 - Brisk Walking Study in Nursing Home Residents N/A
Recruiting NCT04125953 - Stochastic Modulated Vibrations on Autonomic Nervous System of Breast Cancer Patients During Radiotherapy N/A
Completed NCT03613961 - Effects of Propofol Induction Anaesthesia on the Heart Rate Variability
Completed NCT05906940 - Vagus Nerve Stimulation for Autonomic Nervous System Activity N/A
Completed NCT03704025 - Home-based Exercise Training in Cardiac Patients N/A
Completed NCT03441009 - Metabolism and the Activity of the Autonomic Nervous System in Patients With Paroxystic Sympathetic Hyperactivity, PSH
Completed NCT02163967 - Effect of CES on Parasympathetic Tone Phase 4
Completed NCT03479697 - HIRREM for Stage 1 Primary Hypertension N/A
Completed NCT05500716 - The Effect of Vagus Nerve Stimulation on Temporomandibular Joint Dysfunction N/A
Recruiting NCT04732572 - Brain Tissue Integrity and Autonomic Function Alterations in Childhood OSA and ADHD, and After Adenotonsillectomy. N/A

External Links