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Inorganic Nitrate

Inorganic Nitrate for Heart Failure

Phase 1 & 2

Waitlist Available

Led By Linda R Peterson, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable medical therapy - defined by no addition or removal (or change of more than 100%) of the following: beta-adrenergic blockade, angiotensin converting enzyme (ACE) inhibitors, or angiotensin receptor blocker (ARB or aldosterone antagonists) for 30 days prior to enrolment

Diagnosis of heart failure with reduced ejection fraction (NYHA II-IV)

Must not have

Active myocarditis

Estimated glomerular filtration rate < 50 ml/min on most recent clinical laboratories

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time 0 (before receiving the kno3 dose) and hourly after receiving kno3 (1, 2, and 3 hours post-dose)

Awards & highlights

No Placebo-Only Group

Summary

This trial is to study the effects of inorganic nitrate on blood pressure, blood nitrate levels, breath nitric oxide levels, and exercise performance, in order to see if it is an effective therapy for heart failure.

Who is the study for?

This trial is for adults aged 18-75 with heart failure characterized by reduced ejection fraction (NYHA II-IV) and stable on certain heart medications. Excluded are pregnant individuals, those with severe liver disease, recent other nitrate treatments, complex heart issues, or conditions affecting exercise test performance.

What is being tested?

The study tests if potassium nitrate pills can improve blood pressure, blood nitrate levels, breath NO levels, and exercise performance in heart failure patients. It compares the effects of these pills to beetroot juice shots and looks at different doses.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects of nitrates like potassium nitrate may include headaches, dizziness, flushing or a drop in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart medication doses haven't changed significantly in the last 30 days.

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I have been diagnosed with heart failure where my heart doesn’t pump well.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have inflammation of the heart muscle.

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My kidney function is reduced, with a filtration rate under 50 ml/min.

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I haven't taken phosphodiesterase inhibitors in the last 3 months and am willing to avoid them during the trial.

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I have a complex heart condition present since birth.

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I have been diagnosed with thickened heart muscles.

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I have chest pain due to heart artery disease.

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I have had heart surgery or a procedure to improve blood flow to the heart in the last 3 months.

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I have severe heart valve leakage.

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I have severe liver disease without taking blood thinners, shown by brain issues, INR >1.7, or bleeding from enlarged veins.

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I need extra oxygen to breathe at rest or during physical activity.

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I have a terminal illness and am expected to live less than a year.

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I have an active collagen vascular disease.

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I do not have any major health issues that would stop me from doing exercise tests.

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I have atrial fibrillation or flutter.

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I have moderate to severe narrowing of my heart valves.

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My heart condition is due to infiltrative cardiomyopathy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time 0 (before receiving the kno3 dose) and hourly after receiving kno3 (1, 2, and 3 hours post-dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time 0 (before receiving the kno3 dose) and hourly after receiving kno3 (1, 2, and 3 hours post-dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time 0 (before receiving the kno3 dose) and hourly after receiving kno3 (1, 2, and 3 hours post-dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

VO2peak

Secondary study objectives

Blood Nitrite Levels

Breath Nitric Oxide (NO) Level

Peak Muscle Power

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 20mmol KNO3Experimental Treatment1 Intervention

Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10 or 20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and the other dose (10 or 20 mmol KNO3) during dose visit 2. The dose order will be randomized.

Group II: 10mmol KNO3Experimental Treatment1 Intervention

0 / 19Eligibility criteria met