Inorganic Nitrate as a Treatment for ANOCA: NO-ANOCA

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Virginia

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • 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

  • 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

Treatment groups

8 Participants
are divided into 2 treatment groups
Group A: Beetroot juice followed by placeboOther 1 intervention
Group B: Placebo followed by Beetroot juiceOther 1 intervention

Trial outcomes

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

Time frame
From enrollment to day 14

Secondary outcomes

1

Submaximal Exercise Economy

Submaximal Exercise Economy is calculated by a change in oxygen consumption (VO2 in mL/kg/min) from baseline to day 14.

Time frame
From enrollment to day 14
2

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.

Time frame
From enrollment to day 14
3

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.

Time frame
From enrollment to day 14

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: