Who is eligible for clinical trial NCT06948201?

Participants must meet protocol criteria for Coronary Microvascular Dysfunction (CMD). Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06948201 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-04-23

Inorganic Nitrate as a Treatment for ANOCA: NO-ANOCA (NCT06948201)

🟡 Not Yet Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: University of Virginia

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (27 items).

Location: University of Virginia — Charlottesville, Virginia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Virginia — Charlottesville, Virginia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗