The TRUST Study - CardioVascular Imaging IMT

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: University Hospital, Geneva; University of Lausanne Hospitals
• Treatments: Carboxymethylcellulose Sodium

Criteria

Inclusion Criteria:

• Community-dwelling patients aged >= 65 years with subclinical hypothyroidism

• Written informed consent

Exclusion Criteria:

• Subjects currently under levothyroxine or antithyroid drugs (amiodarone, lithium)

• Recent thyroid surgery or radio-iodine (within 12 months)

• Grade IV NYHA heart failure

• Prior clinical diagnosis of dementia

• Recent hospitalization for major illness or elective surgery (within 4 weeks)

• Terminal illness

• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

• Subjects who are participating in ongoing RCTs of therapeutic interventions (including CTIMPs)

• Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period)