Heat Intolerance in the Group of FMF Patients

Related Clinical Trial
Study of Colchicine Resistance in Familial Mediterranean Fever Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever Central Sensitization in Familial Mediterranean Fever (FMF) Efficacy and Safety of RPH-104 for Resolution and Prevention of Recurring Attacks in Adult Subjects With Familial Mediterranean Fever With Resistance to or Intolerance of Colchicine Effects of Online Aerobic Exercise Training and Physical Activity Counseling in Juvenile Familial Mediterranean Fever Characterization of a Functional Test for Mediterranean Family Fever Screening – 2 Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis Heat Intolerance in the Group of FMF Patients Magnetic Resonance (MR) Spectroscopy In Familial Mediterranean Fever (FMF) Patients Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients The Comparison of the Efficacy of Once and Twice Daily Colchicine Dosage in Pediatric Patients With FMF Inflammatory Proteins in Familial Mediterranean Fever During Attack and Remission Tocilizumab for the Treatment of Familial Mediterranean Fever Controlled Ceasing of Colchicine Therapy in Familial Mediterranean Fever (FMF) Patients With Single MEFV (Mediterranean Fever) Gene Mutation The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever. A Diagnostic Test for Familial Mediterranean Fever Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever Rilonacept for Treatment of Familial Mediterranean Fever (FMF)

Brief Title

Heat Intolerance in the Group of FMF Patients

Official Title

Heat Intolerance in the Group of FMF Patients

Brief Summary

      There now causation between Heat Intolerance and FMF that were showed in studies till now. We
      suggest that the prevalence of Heat Intolerance in the group of the FMF patients will be
      significantly higher than in the group of healthy individuals, that participated in the study
      of Heller Institute of Medical Research. The aim of the study is verification of causation
      between these pathologies. The information obtained by the study may allow us to determine
      the sequence of events associated with FMF attack development, and perhaps take us one step
      further in the understanding of the pathogenesis of the disease.

      15 FMF patients with double mutations MEFV, mail sex, from the age from 18 to 30 without
      attacks during not less than 2 month will participate in the study. To identify an
      individuals susceptibility to exercise heat test, a Heat Tolerance Test (HTT) will perform,
      according to HTT Protocol of Heller Institute of Medical Research.
    

Detailed Description

      Familial Mediterranean fever (FMF) is a genetic disease, caused by mutations in the FMF gene,
      entitled MEFV. The disease is characterized by painful attacks of inflammation in sites lined
      by serous membranes (e.g. abdominal pain caused by inflammation of the peritoneum, a serous
      membrane surrounding all internal organs within the abdomen, fever during the attack.
      Continuous colchicine treatment prevents attacks in most patients. The pathogenesis of the
      disease, what leads to the attacks, is the questions not yet resolved. We know that there is
      correlation between protein Pyrin and activity of Interleukin 1 (IL1).

      Tolerance to sustain heat stress varies due to individual variation. Under extreme conditions
      of exercise-heat stress, even healthy, well acclimated, physically fit individuals will
      ultimately store heat at the rate that will cause body temperature to rise. Individuals who
      are not able to sustain heat and whose body temperature will start rising earlier and at a
      higher rate than that of others, under the same conditions, are defined as "heat intolerant".

      There now causation between Heat Intolerance and FMF that were showed in studies till now. We
      suggest that the prevalence of Heat Intolerance in the group of the FMF patients will be
      significantly higher than in the group of healthy individuals, that participated in the study
      of Heller Institute of Medical Research. The aim of the study is verification of causation
      between these pathologies. The information obtained by the study may allow us to determine
      the sequence of events associated with FMF attack development, and perhaps take us one step
      further in the understanding of the pathogenesis of the disease.

      15 FMF patients with double mutations MEFV, male sex, from the age from 18 to 30 without
      attacks during not less than 2 month will participate in the study. To identify an
      individuals susceptibility to exercise heat test, a Heat Tolerance Test (HTT) will perform,
      according to HTT Protocol of Heller Institute of Medical Research.
    


Study Type

Observational


Primary Outcome

Rate of heat intolerance defined by the HTT protocol of Heller Institute of Medical Research.


Condition

Familial Mediterranean Fever


Study Arms / Comparison Groups

 FMF patients
Description:  15 FMF patients with double mutations MEFV, mail sex, from the age from 18 to 30. treated with colchicine, without attacks not less than 2 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

15

Start Date

December 2009

Completion Date

December 2025

Primary Completion Date

August 2025

Eligibility Criteria

        Inclusion Criteria:

          -  double mutations MEFV

          -  mail

          -  age from 18 to 30

          -  colchicine treatment

          -  absence of attack during 2 months

        Exclusion Criteria:

          -  individual wish
      

Gender

Male

Ages

18 Years - 30 Years

Accepts Healthy Volunteers

No

Contacts

Avi Livneh, MD, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT01059279

Organization ID

SHEBA-09-7575-AL-CTIL


Responsible Party

Principal Investigator

Study Sponsor

Sheba Medical Center


Study Sponsor

Avi Livneh, MD, Principal Investigator, Sheba Medical Center


Verification Date

April 2019