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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Other forms of heart disease, Disorders of the thyroid gland
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Heart failure (HF) is a clinical syndrome in which patients have typical symptoms and signs resulting from an abnormality of cardiac structure and function. In Europe, 15 million individuals are living with HF and, unlike other cardiovascular conditions, the prevalence of HF continues to rise. Management of HF costs healthcare systems between 1 – 2% of all healthcare-related costs. For example, the average costs of HF in the UK are estimated at €26 million per million population; €37 million per million population in Germany; and €39 million per million per million population in France. Furthermore, outcomes of people with HF are poor, and, sometimes, can be worse than certain types of cancer. Despite some significant improvements in survival rates, approximately 1 in 3 patients admitted to hospital with HF die within 12 months. Beyond the risk of death, HF has a considerable, and lasting, impact on a patient’s health and well-being. The debilitating and chronic nature of this condition impacts all aspects of life and can increase the patient’s dependency on caregivers, leading to social isolation, anxiety and depression. Therefore, newer, safer and cost-effective therapies are required for improving the current management and prognosis of patients with HF. Thyroid hormones (TH) have a number of pleiotropic effects on the cardiovascular system in general and the myocardium in particular. The active TH triiodothyronine (T3) is important for myocardial contractility, acts as a vasodilator and has a direct positive action on myocardial mitochondrial function – processes that are involved in the pathogenesis of HF. Furthermore, ischaemic cardiomyocytes have reduced intra- and extra-cellular T3 levels due to the effects of acute injury on TH-modulating enzymes. The reduction in intracellular T3 has been linked to the development of HF. In rodent models, reduction in tissue T3 levels leads to a state of tissue hypothyroidism, independently of circulating T3 levels. In HF patients on standard therapy, low circulating T3 levels represent a strong independent prognostic predictor of death and major adverse cardiac events. It is therefore possible that T3 therapy in HF patients offers a potentially useful option to improve left ventricular (LV) function as well as morbidity and mortality. Trials of T3 in a small number of patients in other cardiac conditions such as coronary artery bypass grafting surgery have mostly suggested a beneficial impact on LV function. In addition, the safety profile of T3 on heart rate and rhythm has been proven in multiple RCTs in acute as well as chronic cardiac conditions. In the HF setting, there have been three controlled trials to date that have studied a small number of participants with HF and low circulating T3 levels. Of these, two have demonstrated that T3 is effective and safe in improving left ventricular function whereas the third failed to reach statistical significance. Thus, large adequately powered trials of T3 in HF patients with low serum FT3 levels are required to prove efficacy. This project aims to provide initial evidence regarding the feasibility of recruiting to such a trial and the usefulness of the methodology used and the interventional agent in assessing outcomes. The aims of this feasibility project are to evaluate the number of HFrEF patients with low serum FT3 levels and if a trial designed to normalise serum FT3 therapy in patients with chronic stable HF with reduced ejection fraction (HFrEF) and low circulating T3 levels is acceptable to patients and provides initial data of signal of efficacy.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
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 months3. Claustrophobia precluding cardiac magnetic resonance (MR) assessment4. Cardiac devices (such as implantable cardioverter defibrillators) that are incompatible with MR scanning5. Untreated valvular heart disease as the main cause of the HFrEF6. With severely abnormal serum TSH (< 0.1 or > 10.0 mIU/L) or thyroxine (FT4) levels (< 9.0 or > 23.0 pmol/L)7. Participants who are unable to provide written informed consent8. Individuals who are pregnant or trying to conceive
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Salman
Razvi
+44 (0)191 4456052
salman.razvi@ncl.ac.uk
The study is sponsored by Gateshead Health NHS Foundation Trust and funded by National Institute for Health and Care Research; Merck.
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Or CPMS 52501
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