Nitrate Beetroot Juice to Help Blood Flow in Women with ANOCA and CMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial examines if daily 70 mL servings of nitrate-rich beetroot juice improve cardiac perfusion and exercise capacity in women with angina and non-obstructive coronary artery disease due to coronary microvascular dysfunction. Participants will receive either nitrate-rich beetroot juice or nitrate-depleted placebo for two weeks, in a crossover-like design with assessments including stress cardiac MRI, ECGs, questionnaires, cycling tests, noninvasive vascular tests, and blood draws. The study aims to see if increasing nitric oxide bioavailability via dietary nitrate can enhance vascular function and reduce angina and dyspnea. Exploratory analyses will evaluate broader vascular health changes. The total participation involves four weeks of beverage consumption and comprehensive cardiovascular testing to explore potential benefits and mechanisms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.
* No evidence of obstructive epicardial CAD (stenosis \>50%) of a major epicardial vessel or an FFR ≤0.80 by invasive catheterization or CCTA. Patients who have not undergone cardiac catheterization of CT angiogram within the last 2 years for chest pain can be scheduled for a screening CT angiogram of the coronary arteries to confirm eligibility.
* Impaired coronary flow reserve (cut-off values depending on methodology use between ≤2.0 and ≤2.5 by stress testing PET/CMR or Invasive assessment) or Abnormal index of coronary microcirculatory resistance (e.g., IMR \> 25)
* SGLT2i Naïve

Exclusion Criteria:

* 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.
* Severe valvular disease
* Life expectancy \<3 years, due to non-cardiovascular comorbidity.
* Pregnancy or women who are breast-feeding
* Type 1 diabetes mellitus
* Symptomatic hypotension or systolic BP\<95 mmHg on 2 consecutive measurements
* Active malignancy requiring treatment at the time of visit
* Severe (eGFR \<30 mL/min/1.73 m2 by CKD-EPI), unstable, or rapidly progressing renal disease at the time of randomization
* History of recurrent UTI/bladder/kidney infections
* Asthma with ongoing wheezing
* Known or suspected bronchoconstrictive or bronchospastic lung disease (ARDS, emphysema)
* Greater than first degree heart block
* Implanted cardiac device
* Profound sinus bradycardia (heart rates\<40 beats per minute)
* Atrial fibrillation or supraventricular arrhythmias at time of imaging
* Known intolerance of nitrates (other than hypotension)
* History of reaction to iodinated contrast agents
* Any orthopedic, neurological, or other condition that prevents participant from exercising
* Individuals currently taking nitroglycerine (or inorganic nitrates), PDE-5 inhibitors (ex: Cialis, Viagra), and xanthine oxidase inhibitors (ex: Allopurinol)
* Smokers within the last 5 years
* Prisoners
* Cognitively impaired individuals
* Non-English Speaking

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Patricia Rodriguez-Lozano, MD — University of Virginia
• Study coordinator: Shuo Wang
• Email: VJR7CE@uvahealth.org
• Phone: 434-982-1058

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.