Status:
NOT_YET_RECRUITING
Inorganic Nitrate as a Treatment for ANOCA: NO-ANOCA
Lead Sponsor:
University of Virginia
Conditions:
Coronary Microvascular Dysfunction (CMD)
Angina Patients With Non-obstructive Coronary Artery Disease
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Females with heart disease often present unique phenotypes but are underrepresented in clinical trials. In females with angina, 40-65% have non-obstructive coronary artery disease (ANOCA), often due t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06948201
Start Date
May 1 2025
End Date
June 1 2026
Last Update
April 29 2025
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22903