Clinical Trial: Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Autonomic Function and Cardiovascular Risk in Restless Legs Syndrome: AUTOREST, a Case-control Study and a Randomized, Double-blind, Placebo-controlled, Parallel-group, 4-

Brief Summary: The purpose of this study is to explore whether patients with restless legs syndrome (RLS) differ from healthy subjects in daytime and night time autonomic function and cardiovascular risk markers and whether 4 week treatment with pramipexole affects autonomic function and cardiovascular risk markers in patients with RLS.

Detailed Summary:
Sponsor: Mauro Manconi

Current Primary Outcome: Change in heart rate activations during sleep from baseline to 4 weeks [ Time Frame: Baseline, Week 4 ]

Number and amplitude of periodic leg movements during sleep (PLMS) and non-PLMS related heart rate activations during stable nocturnal sleep


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in baroreflex from baseline to 4 weeks [ Time Frame: Baseline, Week 4 ]
    Baroreflex sensitivity and baroreflex gain derived from tilt table tes
  • Change in blood serum markers from baseline to 4 weeks [ Time Frame: Baseline, Week 4 ]
    Highly-sensitive C reactive protein (hsCRP), lipoprotein-associated phospholipase A2 (lP-PLA2), and oxidised low density lipoprotein (oxLDL)


Original Secondary Outcome: Same as current

Information By: Ospedale Regionale di Lugano

Dates:
Date Received: December 23, 2013
Date Started: December 2013
Date Completion:
Last Updated: January 23, 2017
Last Verified: January 2017