Coronary heart disease (CHD) and heart failure (HF) 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 cardiac function. 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 echocardiography at the close-out visit. Assessment of the impact of thyroid
replacement on cardiac function and 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