Coronary heart disease (CHD) are the leading causes of mortality and morbidity, particularly
with the current context of an aging population. Prospective cohort studies, as well as
analyses of pooled individual participant data suggest up to a 60-90% increase in the risk of
CHD or HF events among adults with severe SHypo. However, no large randomized controlled
trials (RCT) have assessed the impact of thyroid replacement on cardiovascular (CV) imaging
outcomes. The goals of this proposal are to address the impact of thyroid replacement on
subclinical atherosclerosis. The investigators will conduct a RCT in 185 patients with
subclinical hypothyroidism who will be randomly assigned to thyroxine or placebo with an
average follow-up of 24 months from baseline. The main outcome will be CV imaging modalities
measured by carotid ultrasound at the close-out visit. Assessment of the impact of thyroid
replacement on subclinical atherosclerosis within a trial will aid decisions and
evidence-based guidelines development to treat a potential modifiable risk factor, such as
SHypo.
Phase:
Phase 4
Details
Lead Sponsor:
University Hospital Inselspital, Berne
Collaborators:
University Hospital, Geneva University of Lausanne Hospitals