About this trial
The purpose of this study is to see if inorganic nitrate in the form of beetroot juice helps blood flow and physical fitness in women with ANOCA and CMD. The main questions it aims to answer are:
AIM 1: Test the hypothesis that fourteen days of nitrate rich beetroot juice will increase cardiac perfusion and improve quality of life compared to placebo.
AIM 2: Test the hypothesis that fourteen days of nitrate rich beetroot juice will increase physical fitness and reduce angina and dyspnea symptoms compared to placebo.
Exploratory AIM 3: Test the hypothesis that fourteen days of nitrate rich beetroot juice will improve vascular health and function.
Participants will:
* Take study beverage for 4 weeks total. * Stress Cardiac magnetic resonance imaging and 12 lead electrocardiograms * Complete questionnaires * Cycling exercise test * Non invasive vascular testing * Blood draws
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Female sex.
Willing and able to provide written informed consent.
Signs and symptoms of suspected ischemia prompted referral for further evaluation by cardiac catheterization or CCTA within two years of consent.
Disqualifiers
History of non-ischemic cardiomyopathy LVEF <40% or hypertrophic cardiomyopathy.
History of congestive heart failure, severe pulmonary disease, liver disease
History of acute coronary syndrome (ACS) within previous 30 days
Stroke within the last 180 days or intracranial hemorrhage at any time.
Trial design
Crossover
Treatments tested in this trial
70mL Nitrate Rich Beetroot Juice followed by placebo (Nitrate depleted beetroot juice)
Dietary supplement70mL Nitrate Rich Beetroot Juice for 14 days followed by placebo (Nitrate depleted beetroot juice) for 14 days
Placebo (70 mL Nitrate depleted beetroot juice) followed by 70mL Nitrate Rich Beetroot Juice
Dietary supplementPlacebo (70 mL Nitrate depleted beetroot juice) for 14 days followed by 70mL Nitrate Rich Beetroot Juice for 14 days
Treatment groups
Trial outcomes
Primary outcomes
Change in Coronary Flow Reserve
Coronary flow reserve is calculated as the ratio of hyperemic myocardial blood flow to the resting myocardial blood flow using cardiovascular magnetic resonance myocardial perfusion imaging
Secondary outcomes
Submaximal Exercise Economy
Submaximal Exercise Economy is calculated by a change in oxygen consumption (VO2 in mL/kg/min) from baseline to day 14.
Angina
Angina is measured using the Seattle Angina Questionnaire from baseline to day 14. Question measurements range from activities being extremely limited to not at all limited by symptoms (chest pain, chest tightness, or angina) with less symptoms associated with better health related quality of life.
Dyspnea Symptoms
Dyspnea symptoms are measured using the Rose Dyspnea Score comparing from baseline to day 14. Less dyspnea symptoms are associated with a better health related quality of life.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: