Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05596643
Other study ID # 09.2021.1427
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date October 31, 2022

Study information

Verified date October 2022
Source Marmara University
Contact Imran Kalkan
Phone +90 530 340 5594
Email imrankalkann55@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Familial Mediterranean Fever (FMF) is the most common inherited autoinflammatory disease affecting 150,000 patients worldwide. Periodic febrile exacerbations, peritonitis, and pleuritis are characteristic disease features. Dysregulation of IL-1β secretion has an important role in the pathophysiology of the disease, and IL-1β also serves as a therapeutic target. Chronic inflammation has been associated with early atherosclerotic and cardiovascular disease in various rheumatic diseases. An increased risk for cardiovascular events associated with disease activity has been described in rheumatoid arthritis, psoriatic arthritis, and systemic lupus erythematosus. In addition, autonomic nervous system dysfunction may contribute to increased cardiovascular risk in patients with inflammatory disease. For example, decreased heart rate variability is an important feature of cardiac autonomic dysfunction and is an isolated risk factor for cardiovascular events. Autonomic dysfunction studies related to FMF have conflicting results. The aim of this study was to determine autonomic dysfunction symptoms and objective findings in patients with FMF; Demographic characteristics, disease characteristics, inflammatory burden, fatigue level, sleep quality, presence of fibromyalgia and their relationship with quality of life were evaluated and compared with healthy controls.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 31, 2022
Est. primary completion date October 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Familial Mediterranean Fever group; 1. Being between the ages of 18-65 2. Having a definite diagnosis of Familial Mediterranean Fever according to Livneh criteria Healthy control group; 1. Being between the ages of 18-65 2. Absence of any disease diagnosis Exclusion Criteria: 1. Liver or kidney failure 2. Pregnancy 3. Diabetes mellitus 4. Thyroid diseases 5. Those who use neuroprotective or antihypertensive drugs 6. Vitamin B12 deficiency 7. Anemia 8. Paraneoplastic neuropathy 9. Alcoholism 10. Cardiac failure 11. Cardiac arrhythmia 12. Acute thrombosis 13. Having a diagnosis of another systemic rheumatic disease 14. Persons who did not give consent to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Composite Autonomic Symptom Score-31
Standardized questionnaire to determine the level of autonomic dysfunction
r-r interval variability with normal breathing
electrophysiological test to detect parasympathetic dysfunction
r-r interval variability with deep breathing
electrophysiological test to detect parasympathetic dysfunction
Valsalva ratio
electrophysiological test to detect parasympathetic dysfunction
30:15 ratio
electrophysiological test to detect parasympathetic dysfunction
sympathetic skin response
electrophysiological test to detect sympathetic dysfunction
blood pressure response to standing
clinical test to detect sympathetic dysfunction
blood pressure response to sustained handgrip test
clinical test to detect sympathetic dysfunction
Other:
Hospital anxiety and depression scale
Standardized questionnaire to investigate the depression and anxiety
Diagnostic Test:
Fibromyalgia rapid screening tool
Standardized questionnaire to determine the presence of fibromyalgia
Other:
Familial Mediterranean Fever Quality of life scale
Standardized questionnaire to investigate the quality of life in Familial Mediterranean Fever patients
Jenkins Sleep Evaluation Scale
Standardized questionnaire to investigate the sleep quality and disturbance
The Fatigue Severity Scale
Standardized questionnaire to investigate the fatigue severity

Locations

Country Name City State
Turkey Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite Autonomic Symptom Score-31 It is a widely applicable, up-to-date, easy-to-apply and scientifically-based test that evaluates autonomic symptoms and functions by the person himself. It consists of 31 multiple-choice questions in 6 autonomic areas: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder function and pupillomotor areas. A score in the range of 0-100 is obtained as a result of multiplying each area by the weight factor determined by the study. High score indicates presence and severity of autonomic dysfunction. 6 months
Primary r-r interval variability with normal breathing The active and reference superficial recording electrodes are on the dorsal side of both hands, and the ground electrode is placed on the wrist. The R-R interval variability is calculated automatically by the electromyography device over a 1-minute recording. 6 months
Primary r-r interval variability with deep breathing The active and reference superficial recording electrodes are on the dorsal side of both hands, and the ground electrode is placed on the wrist. In order to determine the R-R interval variability with deep breathing, the patient is given 6 to 8 deep breaths, consisting of 5 seconds of inspiration followed by 5 seconds of expiration, and the result is automatically calculated by the electromyography device. 6 months
Primary Valsalva ratio The active and reference superficial recording electrodes are on the dorsal side of both hands, and the ground electrode is placed on the wrist. The test was performed by asking the subject to sit quietly and then blow into a mouthpiece attached to an aneroid pressure gauge at a pressure of 40 mmHg for 15 seconds. The ratio of the longest R-R interval shortly after the manoeuver (within about 20 beats) and the shortest R-R interval during the manoeuver is then measured. The result was expressed as the Valsalva ratio that is taken as the mean ratio from three successive Valsalva manoeuvers. 6 months
Primary 30:15 ratio The active and reference superficial recording electrodes are on the dorsal side of both hands, and the ground electrode is placed on the wrist.The R-R interval on the ECG was recorded and used to determine the instantaneous HR at rest and then on the 15th and 30th beats after standing. The HR should normally rise after about 30 seconds as part of the response to return the blood pressure (BP) to normal. After standing up, the 30:15 ratio obtained by dividing the longest R-R distance around the 30th beat by the shortest R-R distance around the 15th beat was calculated automatically by the EMG device. 6 months
Primary sympathetic skin response Sweating that occurs in response to many different stimuli, electrolyte in the skin triggers changes in skin conductivity, resulting in instantaneous changes in skin conductivity. Sympathetic skin response evaluates these instantaneous changes in the skin in response to sweating. Sympathetic skin response reflects the function of sympathetic nerve fibers.Active recording electrodes on palm and sole; reference electrodes is placed on the back of the hand and the back of the foot. Responses obtained by applying electrical current over the median nerve trace are evaluated. 6 months
Primary blood pressure response to standing Participants were asked to stand up for 3 minutes after a 10-minute resting period in a supine position. The systolic and diastolic BP (SBP and DBP) just before standing, and 3 minutes after active standing were determined, in order to define postural change in BP and to evaluate orthostatic intolerance. 6 months
Primary blood pressure response to sustained handgrip Blood pressure measurement is continued at 1-minute intervals while patients perform sustained handgip at 30% of their maximum volitional strength for 5 minutes.The absolute difference between the highest DBP during handgrip and the basal DBP just before the handgrip was noted. 6 months
Secondary Familial Mediterranean Fever Quality of Life Scale (FMF-QoL) FMF-QoL was developed to evaluate the quality of life in FMF patients. This scale consists of 20 questions in the form of a Likert scale and the total scoring is between 0-80. High scores indicate a decrease in quality of life. 6 months
Secondary Hospital Anxiety and Depression Scale (HADS) This scale consists of 14 questions in total, and anxiety symptoms are questioned in half of the questions and depression-related complaints in the other half. A subscore of 8 or higher for depression or anxiety is considered a clinical case. 6 months
Secondary Fibromyalgia Rapid Screening Tool (FIRST) This scale consists of 6 questions investigating the most relevant clinical features of fibromyalgia. The questions are answered as yes/no and 5 or more out of 6 points in total are in favor of fibromyalgia. 6 months
Secondary The Fatigue Severity Scale (FSS) It consists of a total of 9 questions in which complaints related to fatigue are scored between 0 and 7, taking into account the fatigue in the last week. The mean score is obtained by dividing the total score by 9, and it is defined as <4.0 points as no fatigue, 4.0-5.0 points at the border, and >5.0 points as fatigue. 6 months
Secondary Jenkins Sleep Evaluation Scale (JSS) It is a scale in which scores between 0 and 5 are made for each symptom by questioning how many days in a month 4 sleep-related symptoms are experienced considering the last 1 month. The total score is between 0-20, and as the score increases, sleep quality deteriorates. 6 months
See also
  Status Clinical Trial Phase
Completed NCT02099890 - The Effect of Diet on Chronic Inflammation and Related Disorders Following Spinal Cord Injury Phase 3
Recruiting NCT05700903 - Contributions to Hypertension With Androgen Deprivation Therapy Phase 4
Recruiting NCT04611334 - The Effects of HRV Biofeedback on Chronic Kidney Disease Patient. N/A
Completed NCT01249248 - PD2i Analysis of Heart Rate Variability in Competitive Sports N/A
Recruiting NCT03721445 - Could HRV be a Valuable Predictor for CPAP Adherence?
Not yet recruiting NCT06419959 - NightWare and Cardiovascular Health in Veterans With PTSD N/A
Completed NCT03865225 - Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischemic Stroke N/A
Not yet recruiting NCT05098977 - The Usefulness of Assessing Heart Rate Variability in Patients With Acute Myocardial Infarction
Active, not recruiting NCT05896982 - Optimizing Patient Experience During Myocardial Perfusion Imaging N/A
Completed NCT03515122 - The Swedish Spinal Cord Injury Study on Cardiopulmonary and Autonomic Impairment
Recruiting NCT04632134 - Long-term Effects of Transcutaneous Vagal Nerve Stimulation on Postural Orthostatic Tachycardia Syndrome (POTS) N/A
Recruiting NCT06465134 - Mechanisms for Atrial Fibrillation in Obstructive Sleep Apnea
Not yet recruiting NCT05315739 - Vagus Nerve Stimulation for Systemic Lupus Erythematous N/A
Completed NCT01877993 - The Effect of Autonomic Function on Coronary Vasomotion N/A
Recruiting NCT04752293 - Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
Not yet recruiting NCT05977335 - Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)
Not yet recruiting NCT06288828 - The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients With Compensated Cirrhosis N/A
Recruiting NCT06289413 - Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study
Completed NCT02612389 - Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants N/A
Recruiting NCT03911609 - Cardiovascular Autonomic Function and Endogenous Pain Modulation N/A