Other forms of heart disease, Disorders of the thyroid gland Nutritional, Metabolic, Endocrine
Conditions
Interventions
The study design is a single-centre prospective open-label feasibility interventional before-after trial of T3 therapy for 3 months. There are two parts to the study design.
Part 1
Participants wil
Sponsors
Gateshead Health NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged between 18 – 80 years 2. Stable HFrEF (no admission to hospital with HF exacerbations in the previous 3 months) 3. Chronic HFrEF (diagnosed more than 3 months prior to recruitment) 4. Moderate – severe systolic left ventricular dysfunction (LVEF < 45% on cardiac echocardiogram within last 6 months) 5. On standard HFrEF therapy 6. With low serum T3 levels (< 3.5 pmol/L)
Exclusion criteria
Exclusion criteria: 1. Those on medications affecting thyroid function (such as levothyroxine, antithyroid drugs, amiodarone, lithium and sodium valproate) 2. Patients admitted to hospital with acute exacerbation of HF in the preceding 3 months 3. Claustrophobia precluding cardiac magnetic resonance (MR) assessment 4. Cardiac devices (such as implantable cardioverter defibrillators) that are incompatible with MR scanning 5. Untreated valvular heart disease as the main cause of the HFrEF 6. With severely abnormal serum TSH ( 10.0 mIU/L) or thyroxine (FT4) levels ( 23.0 pmol/L) 7. Participants who are unable to provide written informed consent 8. Individuals who are pregnant or trying to conceive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acceptability of trial design measured using the number of participants recruited /number of participants approached at baseline; the information is obtained from the study recruitment log 2. Retention of trial participants measured using the number of participants completing the study/number of participants recruited; the information is obtained from study records and recruitment log 3. Rate of recruitment: calculated as the number of participants recruited per month; the information is obtained from the study recruitment log | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with chronic and stable HFrEF with low serum FT3 levels at baseline; information obtained from study case report form 2. Change in LVEF at 3 months compared to baseline using cardiac MRI 3. Change in left ventricular systolic and diastolic diameters at 3 months compared to baseline – assessed by cardiac MRI 4. Change in N-terminal-pro brain natriuretic peptide (NT-pro BNP) and markers of inflammation (hsCRP) at 3 months from baseline 5. Change in thyroid function tests at 3 months from baseline 6. Health and Quality of life parameters measured using the EQ-5D and Minnesota Living with Heart Failure questionnaires assessed at baseline and at 3 months 7. Exercise capacity measured using the 6-minute walking distance at baseline and at 3 months 8. Pulse rate and rhythm (new-onset atrial fibrillation), admissions to hospital, and NYHA classification at baseline and at 3 months 9. Compliance with study medication measured using tablet counting at 3 months | — |
Countries
England, United Kingdom
Outcome results
None listed