~5 spots leftby Apr 2026

Inorganic Nitrate for Heart Failure

Recruiting in 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.
My heart's pumping ability is below 45%.
I have been diagnosed with heart failure where my heart doesn’t pump well.
See 2 more

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
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.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who Is Running the Clinical Trial?

Washington University School of MedicineLead Sponsor

References