The Impact of Levothyroxine on Cardiac Function in Older Adults with Mild Subclinical Hypothyroidism: a Randomized Clinical Trial.

Gencer, Baris; Moutzouri, Elisavet; Blum, Manuel; Feller, Martin; Collet, Tinh-Hai; Del Giovane, Cinzia; Da Costa, Bruno R.; Buffle, Eric; Monney, Pierre; Gabus, Vincent; Müller, Hajo; Sykiotis, Gerasimos P; Kearney, Patricia; Gussekloo, Jacobijn; Westendorp, Rudi; Stott, David J; Bauer, Douglas C; Rodondi, Nicolas (2020). The Impact of Levothyroxine on Cardiac Function in Older Adults with Mild Subclinical Hypothyroidism: a Randomized Clinical Trial. American journal of medicine, 133(7), 848-856.e5. Elsevier 10.1016/j.amjmed.2020.01.018

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BACKGROUND

Subclinical hypothyroidism has been associated with heart failure, but only small trials assessed whether treatment with levothyroxine has an impact on cardiac function.

METHODS

In a randomized, double-blind, placebo-controlled, trial nested within the TRUST trial, Swiss participants aged ≥65 years with subclinical hypothyroidism (thyroid-stimulating hormone, TSH, 4.60-19.99 mIU/L; free thyroxine level within reference range) were randomized to levothyroxine (starting dose of 50 µg daily) to achieve TSH normalization, or placebo. The primary outcomes were the left ventricular ejection fraction for systolic function, and the ratio between mitral peak velocity of early filling to early diastolic mitral annular velocity (E/e' ratio) for diastolic function. Secondary outcomes included e' lateral/septal, left atrial volume index and systolic pulmonary artery pressure.

RESULTS

185 participants (mean age 74.1 years, 47% women) underwent echocardiography at the end of the trial. After a median treatment duration of 18.4 months, the mean TSH decreased from 6.35 mIU/L to 3.55 mIU/L with levothyroxine (n=96), while it remained elevated at 5.29 mIU/L with placebo (n=89). The adjusted between-group difference was not significant for the mean left ventricular ejection fraction (62.7% vs. 62.5%, difference=0.4%, 95%CI -1.8% to 2.5%, P=0.72) and the E/e' ratio (10.6 vs. 10.1, difference 0.4, 95%CI -0.7-1.4, P=0.47). No differences were found for the secondary diastolic function parameters, nor for interaction according to sex, baseline TSH, preexisting heart failure and treatment duration (P-value >0.05).

CONCLUSION

Systolic and diastolic heart function did not differ after treatment with levothyroxine compared with placebo in older adults with mild subclinical hypothyroidism.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Moutzouri, Elisavet; Blum, Manuel; Feller, Martin; Del Giovane, Cinzia; Da Costa, Bruno; Buffle, Eric Jacques and Rodondi, Nicolas

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0002-9343

Publisher:

Elsevier

Funders:

[4] Swiss National Science Foundation

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

09 Apr 2020 10:15

Last Modified:

10 Dec 2020 19:18

Publisher DOI:

10.1016/j.amjmed.2020.01.018

PubMed ID:

32171774

Uncontrolled Keywords:

Clinical Trials Heart failure Levothyroxine Subclinical Hypothyroidism Thyroid

BORIS DOI:

10.7892/boris.142356

URI:

https://boris.unibe.ch/id/eprint/142356

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