Inorganic Nitrate for Heart Failure

Palo Alto (17 mi)

Linda R. Peterson, MD, FACC, FAHA, FASE ...

Overseen byAndrew R Coggan, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to do the work that is necessary and sufficient for setting up an appropriate multi-center, randomized clinical trial (RCT) of a new therapy for heart failure: inorganic nitrate. The investigators will first determine the effects and palatability of \~12.8mmol KNO3 (an oral pill) as compared to the roughly equivalent amount of nitrate in 2 beetroot juice (BRJ) Sports Shots (by James White Drinks). Next, the investigators will determine the effects of inorganic nitrate (KNO3 in an oral pill format) on blood pressure, blood nitrate levels, breath nitric oxide (NO) levels, and exercise performance in a dose-response study. Third, the investigators will perform a small phase II chronic treatment study that will allow them to determine the best primary endpoint and the numbers of patients the investigators will need to study in the large, multi-center RCT to follow this project. In the small study and in the RCT to follow, the investigators will determine whether inorganic nitrate can improve aerobic exercise capacity, muscle power, and speed of muscle contraction, and lessen the effort of breathing during exercise.

Eligibility Criteria

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.

Inclusion Criteria

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

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

I am between 18 and 75 years old.

Exclusion Criteria

I have inflammation of the heart muscle.

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

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

I have a complex heart condition present since birth.

I have been diagnosed with thickened heart muscles.

I have chest pain due to heart artery disease.

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

I have severe heart valve leakage.

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

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

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

I have an active collagen vascular disease.

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

I have atrial fibrillation or flutter.

I have moderate to severe narrowing of my heart valves.

My heart condition is due to infiltrative cardiomyopathy.

Treatment Details

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.

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