Inorganic Nitrate as a Treatment for ANOCA: NO-ANOCA

NCT06948201 | Not Yet Recruiting

• 1 other identifier: 302494
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 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

Conditions

Coronary Microvascular Dysfunction (CMD); Angina Patients With Non-obstructive Coronary Artery Disease

Keywords

angina; ANOCA; Non-obstructive Coronary Artery Disease; CMD; Non-Obstructive CAD; Chest Pain in Women

Outcome Measures

Primary Outcomes (1)

• 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

  From enrollment to day 14

Secondary Outcomes (3)

• Submaximal Exercise Economy

  From enrollment to day 14

• Angina

  From enrollment to day 14

• Dyspnea Symptoms

  From enrollment to day 14

Study Arms (2)

Beetroot juice followed by placebo

OTHER

70mL Nitrate Rich Beetroot Juice for 14 days followed by placebo (70mL nitrate depleted beetroot juice) for 14 days

Dietary Supplement: 70mL Nitrate Rich Beetroot Juice followed by placebo (Nitrate depleted beetroot juice)

Placebo followed by Beetroot juice

OTHER

Placebo (70 mL nitrate depleted beetroot juice) for 14 days followed by Nitrate rich Beetroot juice for 14 days

Dietary Supplement: Placebo (70 mL Nitrate depleted beetroot juice) followed by 70mL Nitrate Rich Beetroot Juice

Interventions

70mL Nitrate Rich Beetroot Juice followed by placebo (Nitrate depleted beetroot juice) DIETARY_SUPPLEMENT

70mL Nitrate Rich Beetroot Juice for 14 days followed by placebo (Nitrate depleted beetroot juice) for 14 days

Beetroot juice followed by placebo

Placebo (70 mL Nitrate depleted beetroot juice) followed by 70mL Nitrate Rich Beetroot Juice DIETARY_SUPPLEMENT

Placebo (70 mL Nitrate depleted beetroot juice) for 14 days followed by 70mL Nitrate Rich Beetroot Juice for 14 days

Placebo followed by Beetroot juice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Rodriguez-Lozano, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuo Wang

CONTACT

434-982-1058; VJR7CE@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-site, double-blind, randomized crossover pilot study

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 29, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)