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Inorganic Nitrate
Inorganic Nitrate for Heart Failure
Phase 1 & 2
Waitlist Available
Led By Andrew R Coggan, PhD
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)
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
VO2peak
Secondary outcome measures
Blood Nitrite Levels
Breath Nitric Oxide (NO) Level
Peak Muscle Power
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
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.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,667 Total Patients Enrolled
18 Trials studying Heart Failure
78,031 Patients Enrolled for Heart Failure
Andrew R Coggan, PhDPrincipal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
139 Total Patients Enrolled
1 Trials studying Heart Failure
126 Patients Enrolled for Heart Failure
Linda R Peterson, MDPrincipal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
768 Total Patients Enrolled
2 Trials studying Heart Failure
201 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 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.Your blood pressure is too low (less than 95 mmHg) or too high (more than 180 mmHg) when checked.I have a complex heart condition present since birth.My heart medication doses haven't changed significantly in the last 30 days.Your heart's pumping function is strong, with an ejection fraction higher than 45%.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.My heart's pumping ability is below 45%.I have a terminal illness and am expected to live less than a year.I have been diagnosed with heart failure where my heart doesn’t pump well.I have an active collagen vascular disease.I haven't taken nitrate medication in the last 3 months.I do not have any major health issues that would stop me from doing exercise tests.I have atrial fibrillation or flutter.I am between 18 and 75 years old.Your diastolic blood pressure is too low (less than 40 mmHg) or too high (more than 100 mmHg) when checked at the start of the study.You had a bad reaction to nitrates and had to stop taking them.I have moderate to severe narrowing of my heart valves.I am either male or female.My heart condition is due to infiltrative cardiomyopathy.
Research Study Groups:
This trial has the following groups:- Group 1: 10mmol KNO3
- Group 2: 20mmol KNO3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has any prior research been conducted regarding KNO3, potassium nitrate?
"Currently, 4 clinical trials dedicated to the investigation of potassium nitrate (KNO3) are being conducted. Of these studies, 1 is in Phase 3 and the other three span over four separate locations located in Santiago, Región Metropolitana."
Answered by AI
Is the age threshold for participation in this trial set above 55 years old?
"This research endeavour is seeking participants aged 18 and above, yet not exceeding 74 years of age."
Answered by AI
What criteria is necessary for a person to qualify for enrollment in this trial?
"This research project aims to recruit 20 individuals between 18 and 74, all of whom are suffering from heart failure. The necessary requirements for eligibility include stable medical therapy over the preceding 30 days - with no major addition or removal (or change greater than 100%) of beta-adrenergic blockers, ACE inhibitors or angiotensin receptor blockers - as well as an age within the range mentioned previously."
Answered by AI
What is the capacity for enrollment in this clinical trial?
"This clinical trial is no longer recruiting participants; it was initially posted in October 2017 and last updated on February 2022. Alternatively, those looking for medical studies may be interested to know that 700 heart failure trials are currently being conducted and 4 KNO3 (potassium nitrate) research initiatives are actively enrolling patients."
Answered by AI
Are there any spots available for participation in this experiment?
"Unfortunately, the trial posted on clinicaltrials.gov is no longer actively recruiting patients after its last update in February of 2022. Nonetheless, there are 704 other medical studies seeking participants at this time."
Answered by AI
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