RecruitingPhase 2ACTRN12623000120673

The Anti-Anginal effect of Zinc in Angina with Non-Obstructive Coronary Arteries (ANOCA) Patients


Sponsor

The University of Adelaide

Enrollment

50 participants

Start Date

Oct 24, 2023

Study Type

Interventional

Conditions

Summary

In 30% of patients with angina, angiography does not reveal obstructive coronary artery disease and the myocardial ischaemia may arise from large vessel coronary artery spasm (vasospastic angina) or coronary microvascular dysfunction (microvascular angina). Collectively, these patients are labelled as ANOCA (Angina with Non Obstructive Coronary Arteries) with 1,800 patients/year being afflicted within South Australia. These patients are significantly disabled with an impaired quality of life and have limited available effective therapies, except for calcium channel blockers in vasospastic angina. There is a need to develop novel therapies that effectively target coronary vasomotor dysfunction. Zinc (Zn), an essential micronutrient, is critical to the functioning of many metalloenzymes and transcription factors. Deficiency of Zn can exacerbate or complicate disease in multiple organ systems. We have demonstrated the importance of Zn homeostasis for the vasculature, including potentiating vasodilator responses via the nitric oxide production and inhibiting endothelin-1-induced constriction. We have recently conducted the first systematic study in Australian cardiac patients, showing a high prevalence of Zn deficiency (29%, n = 400), associated with worse disease. This study is a randomised, double-blind, placebo-controlled crossover study assessing the anti-anginal benefits and impact on health status of Zn 30mg once daily in ANOCA patients experiencing angina at least 3 times/week.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Angina is chest pain caused by reduced blood flow to the heart. In about 30% of patients with angina, the large heart arteries look completely normal on a scan — meaning the problem lies in either spasm of the arteries or tiny blood vessels that aren't working properly. This is called ANOCA (Angina with Non-Obstructive Coronary Arteries) and it can be severely disabling. Treatment options are limited, and there is an urgent need for new therapies. This study is testing whether zinc supplements — an essential mineral that plays a role in blood vessel function — can reduce angina episodes and improve quality of life in ANOCA patients. It is a crossover trial where all participants will receive both zinc and a placebo (dummy pill) at different times, so researchers can compare the two periods fairly. You may be eligible if you are 18 or older, have been diagnosed with ANOCA through an angiogram (heart artery scan), and experience chest pain at least 3 times a week. People with a recent heart attack, severely abnormal liver or kidney function, or significant anaemia are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Zinc Tablets - Nature's Own Australia - Dose - 30mg once daily - Duration - 8 weeks (4 weeks drug intervention and 4 weeks placebo) - The mode of administration - oral tablet Each subject will u

Zinc Tablets - Nature's Own Australia - Dose - 30mg once daily - Duration - 8 weeks (4 weeks drug intervention and 4 weeks placebo) - The mode of administration - oral tablet Each subject will undergo treatment with Zibotentan and matched placebo for 4 weeks in a computer-generated random order (double-blind, crossover design) giving a total dosing period of 8 weeks. There will be a 2-week washout interval between the two treatment periods. Participants will report the angina frequency through an angina diary. The drug compliance will be assessed through drug tablet return.


Locations(1)

The Queen Elizabeth Hospital - Woodville

SA, Australia

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ACTRN12623000120673