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Inorganic Nitrate
Nitrate Supplementation for Heart Failure (iNIX-HF Trial)
Phase 2
Recruiting
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
Be older than 18 years old
Must not have
Valvular heart disease with severe regurgitation or stenosis of any valve
Active collagen vascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up determined at visit 1, visit 2, and visit 3, which will be scheduled throughout 8 weeks.
Summary
This trial tests if taking potassium nitrate daily can help people with heart failure improve their muscle strength and exercise ability. The study involves an initial test followed by a period of daily doses. Potassium nitrate may work by improving blood flow in the body.
Who is the study for?
This trial is for adults with heart failure where the heart's left ventricle doesn't pump well (ejection fraction <45%). They should be in a stable condition without recent changes to key medications and not involved in other studies. Excluded are pregnant women, those with severe liver disease, recent major cardiovascular procedures, or conditions that prevent exercise testing.
What is being tested?
The iNIX-HF study tests if KNO3 can improve muscle power and aerobic performance in heart failure patients compared to a placebo. Participants will receive either KNO3 or placebo over six weeks and undergo exercise tests to measure any improvements.
What are the potential side effects?
While specific side effects of KNO3 aren't listed here, nitrates commonly cause headaches, dizziness, flushing, low blood pressure, and may interact with certain medications like phosphodiesterase inhibitors.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe heart valve disease.
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I have an active collagen vascular disease.
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I have severe liver disease with symptoms like confusion or bleeding from enlarged veins.
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I have a specific heart condition like thickened heart muscle, amyloidosis, heart inflammation, or a complex congenital heart disease.
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I am pregnant or a postmenopausal woman on hormone replacement therapy.
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I have ongoing chest pain or heart issues due to blocked heart arteries.
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My heart pumps well, with an ejection fraction of 45% or higher.
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I need extra oxygen when I'm resting or moving.
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I am not taking medication for gout.
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I have a terminal illness and am expected to live less than one year.
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I don't have any major health issues that would stop me from doing exercise tests.
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My kidney function is reduced, with a filtration rate below 45 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ determined at visit 1, visit 2, and visit 3, which will be scheduled throughout 8 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~determined at visit 1, visit 2, and visit 3, which will be scheduled throughout 8 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximal muscle power
VO2 Peak Testing
Secondary study objectives
Breath nitric oxide (NO) level
KCCQ questionnaire
MLHFQ questionnaire
+3 moreSide effects data
From 2016 Phase 2 trial • 12 Patients • NCT0225634533%
GI symptoms
33%
Any side effect
33%
Mild lower extremity edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized to KCl
Randomized to KNO3
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Potassium Nitrate (KNO3) treatment armExperimental Treatment1 Intervention
10 mmol of KNO3 via a single gel capsule to be consumed orally once per day for 6 weeks.
Group II: Placebo-controlled armPlacebo Group1 Intervention
10 mmol of placebo via a single gel capsule to be consumed orally once per day for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KNO3
2015
Completed Phase 2
~20
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Heart Failure with Reduced Ejection Fraction (HFrEF) include beta-blockers, ACE inhibitors, ARBs, and diuretics. These medications work by reducing the workload on the heart, lowering blood pressure, and preventing fluid buildup.
Potassium nitrate, which enhances nitric oxide availability, is being studied for its potential to improve exercise performance in HFrEF patients. Nitric oxide is a vasodilator that helps relax blood vessels, improving blood flow and reducing the heart's workload.
This is crucial for heart failure patients as it can enhance oxygen delivery to tissues, improve exercise capacity, and potentially reduce symptoms and hospitalizations.
Effects of pharmacological treatment of acute myocardial infarction on left ventricular function.Nitrates in myocardial infarction: a current perspective.
Effects of pharmacological treatment of acute myocardial infarction on left ventricular function.Nitrates in myocardial infarction: a current perspective.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,344,187 Total Patients Enrolled
18 Trials studying Heart Failure
77,730 Patients Enrolled for Heart Failure
Linda R Peterson, MDPrincipal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
626 Total Patients Enrolled
2 Trials studying Heart Failure
59 Patients Enrolled for Heart Failure
Lauren K Park, PhDStudy DirectorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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 disease.I have an active collagen vascular disease.I have severe liver disease with symptoms like confusion or bleeding from enlarged veins.My heart medication doses have been stable for the last 60 days.I have a specific heart condition like thickened heart muscle, amyloidosis, heart inflammation, or a complex congenital heart disease.I am pregnant or a postmenopausal woman on hormone replacement therapy.I am willing to stop taking antacids or proton pump inhibitors if my doctor agrees.Your blood pressure is too low (less than 90 over 40) or too high (greater than 180 over 100) during the screening.I have ongoing chest pain or heart issues due to blocked heart arteries.I have heart failure with an ejection fraction under 45% and moderate symptoms.My heart pumps well, with an ejection fraction of 45% or higher.I need extra oxygen when I'm resting or moving.I am not taking medication for gout.I have a terminal illness and am expected to live less than one year.I had a bad reaction to nitrate and haven't taken phosphodiesterase inhibitors in the last 3 months.I have not taken nitrate medication in the last 3 months.I don't have any major health issues that would stop me from doing exercise tests.My kidney function is reduced, with a filtration rate below 45 mL/min.
Research Study Groups:
This trial has the following groups:- Group 1: Potassium Nitrate (KNO3) treatment arm
- Group 2: Placebo-controlled arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.