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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up determined at visit 1, visit 2, and visit 3, which will be scheduled throughout 8 weeks.
Awards & highlights

iNIX-HF Trial Summary

This trial will test whether KNO3 can improve exercise performance in patients with HFrEF.

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.Check my eligibility
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.See study design
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.

iNIX-HF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~determined at visit 1, visit 2, and visit 3, which will be scheduled throughout 8 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and determined at visit 1, visit 2, and visit 3, which will be scheduled throughout 8 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximal muscle power
VO2 Peak Testing
Secondary outcome measures
Breath nitric oxide (NO) level
KCCQ questionnaire
MLHFQ questionnaire
+3 more

Side effects data

From 2016 Phase 2 trial • 12 Patients • NCT02256345
44%
Any side effect
33%
GI symptoms
22%
Headache
11%
Tooth infection
11%
Fatigue
11%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized to KNO3
Randomized to KCl

iNIX-HF 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

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,627 Total Patients Enrolled
18 Trials studying Heart Failure
77,998 Patients Enrolled for Heart Failure
Linda R Peterson, MDPrincipal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
735 Total Patients Enrolled
2 Trials studying Heart Failure
168 Patients Enrolled for Heart Failure
Lauren K Park, PhDStudy DirectorWashington University School of Medicine

Media Library

KNO3 (Inorganic Nitrate) Clinical Trial Eligibility Overview. Trial Name: NCT05562167 — Phase 2
Heart Failure Research Study Groups: Potassium Nitrate (KNO3) treatment arm, Placebo-controlled arm
Heart Failure Clinical Trial 2023: KNO3 Highlights & Side Effects. Trial Name: NCT05562167 — Phase 2
KNO3 (Inorganic Nitrate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05562167 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the short- and long-term effects of potassium nitrate therapy on patients?

"The safety of the Potassium Nitrate treatment arm was rated a 2 due to limited evidence concerning its efficacy. That said, there is some assurance with regards to its safety as this trial has reached Phase 2."

Answered by AI

Are there any opportunities for participants to join this experiment?

"Indeed. According to clinicaltrials.gov, this medical study is still recruiting patients since it was first launched on the 1st of January 2023 and most recently updated on 29th September 2022. It needs 75 people from a single site in order to be completed successfully."

Answered by AI

Is there an age limit for enrollment into this medical experiment?

"According to the conditions laid out in this study, those aged between 19 and 79 are qualified to apply. Additionally, there are 22 trials available for minors and 687 studies dedicated to senior citizens."

Answered by AI

What is the overarching purpose of this clinical research endeavor?

"This 8-week trial will measure Maximal muscle power at Visit 1, 2 and 3. Secondary objectives involve gauging peak muscle velocity, assessing blood nitrate/nitrite concentrations and administering the Kansas City Cardiomyopathy Questionnaire."

Answered by AI

What is the cap for participants in this trial?

"Affirmative. Per the data on clinicaltrials.gov, this medical trial is currently recruiting participants after it was initially posted on January 1st 23 and last updated on September 29th 2022. 75 patients have to be sought from a single site."

Answered by AI

What criteria must a participant meet to be accepted into this experiment?

"This clinical trial seeks 75 individuals aged 19-79 that are suffering from chronic heart failure. To be considered, they must have had a stable medical regimen for the past 60 days, an ejection fraction of less than 45%, and classified as NYHA Class II-III."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF)
2023. "The Inorganic Nitrate and eXercise Performance in Heart Failure (iNIX-HF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05562167.
~50 spots leftby Jan 2028
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