Inorganic Nitrate for Heart Failure

Recruiting in Palo Alto (17 mi)

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

Overseen byLinda R Peterson, MD

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.

Research Team

Linda R Peterson, MD

Principal Investigator

Washington University School of Medicine

Andrew R Coggan, PhD

Principal Investigator

Washington University School of Medicine

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.

My heart's pumping ability is below 45%.

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

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Exclusion Criteria

I have inflammation of the heart muscle.

Pregnancy

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

See 21 more

Treatment Details

Interventions

KNO3 (Inorganic Nitrate)

Trial OverviewThe 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.

Participant Groups

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