Clinical trial NCT05596643: Investigation of Autonomic Dysfunction in Patients With Familial Mediterranean Fever
Official title: Investigation of Autonomic Dysfunction in Patients With Familial Mediterranean Fever
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Familial Mediterranean Fever
Autonomic Dysfunction
Keywords: Familial Mediterranean Fever
Autonomic Dysfunction
r-r interval variability
sympathetic skin response
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with FMF Healthy control group

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite Autonomic Symptom Score-31
timeFrame: 6 months
measure: r-r interval variability with normal breathing
timeFrame: 6 months
measure: r-r interval variability with deep breathing
timeFrame: 6 months
measure: Valsalva ratio
timeFrame: 6 months
measure: 30:15 ratio
timeFrame: 6 months
measure: sympathetic skin response
timeFrame: 6 months
measure: blood pressure response to standing
timeFrame: 6 months
measure: blood pressure response to sustained handgrip
timeFrame: 6 months
Secondary outcomes:
measure: Familial Mediterranean Fever Quality of Life Scale (FMF-QoL)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Fibromyalgia Rapid Screening Tool (FIRST)
timeFrame: 6 months
measure: The Fatigue Severity Scale (FSS)
timeFrame: 6 months
measure: Jenkins Sleep Evaluation Scale (JSS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University
name: Mehmet Tuncay Duruöz, Prof
role: PRINCIPAL_INVESTIGATOR
References: