T3 in Heart Failure

• Research type

  Research Study

• Full title

  Liothyronine to normalise Thyroid Hormones in Heart Failure (T3-HF) – A feasibility study.

• IRAS ID

  309311

• Contact name

  Salman Razvi

• Contact email

  salman.razvi@nhs.net

• Sponsor organisation

  Gateshead NHS Foundation Trust

• ISRCTN Number

  ISRCTN10706683

• Duration of Study in the UK

  1 years, 2 months, 31 days

• Research summary

  Thyroid hormones have a critical role in modulating cardiac contractile function. In patients with heart failure with reduced ejection fraction (HFrEF) serum and tissue levels of the active thyroid hormone triiodothyronine (T3) are reduced. Low serum T3 levels in HFrEF patients are a strong prognostic marker for morbidity and mortality. Trials of T3 therapy in a small number of patients with HFrEF to normalise serum T3 levels have shown initial promise and indicated no safety concerns. This project aims to assess the feasibility of a trial of T3 therapy in patients with moderate to severe HFrEF and low serum T3 levels.

  A prospective open-label interventional before-after feasibility trial of T3 therapy for 3 months will be conducted. Patients with moderate to severe HFrEF (ejection fraction <45%) stable on standard therapy will be invited to have their thyroid function assessed. Of these, those that have normal serum free T3 (FT3) levels ( 3.5 pmol/L) will have their health monitored remotely via NHS records. Those individuals with low serum FT3 levels (<3.5 pmol/L) will be recruited into a feasibility trial. These participants will be treated with oral T3 (Liothyronine) 10 mcg twice daily for 3 months. The primary co-outcomes will be acceptability of trial design (number of participants consented in relation to number of potential participants approached), retention of participants (number of participants completing the trial in relation to number of participants consented) and rate of recruitment (number of participants recruited per month). Secondary outcomes will be changes in heart rate, quality of life, 6-minute walking distance, thyroid function tests, and parameters of inflammation and cardiac function.

  This study will furnish important initial data to assess the feasibility of designing a subsequent larger randomised controlled trial of oral T3 therapy in stable chronic HFrEF patients with low serum T3 levels with the aim to assess efficacy and safety.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  22/SC/0107

• Date of REC Opinion

  5 May 2022

• REC opinion

  Further Information Favourable Opinion