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Inorganic Nitrate

Sodium Nitrite for Heart Failure (PH-HFpEF Trial)

Phase 2
Waitlist Available
Led By Michael Risbano, MD, MA
Research Sponsored by Gladwin, Mark, MD
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 10 weeks

Summary

This trial tests whether taking a nitrite pill can help people with certain heart and lung conditions exercise better by improving blood flow. Nitrate and nitrite supplementation have been studied for their potential to improve cardiovascular function and exercise performance by increasing nitric oxide levels in the blood.

Eligible Conditions
  • Heart Failure
  • Pulmonary Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and Nitrite
Secondary study objectives
Change in Endurance Exercise Time
Change in Right Heart Catheterization (RHC) Hemodynamics - Cardiac Output
Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Capillary Wedge Pressure
+5 more

Side effects data

From 2023 Phase 2 trial • 33 Patients • NCT03015402
38%
Shortness of breath
33%
Headache
29%
Fatigue
25%
Dizziness/Lightheadedness
25%
Nausea
17%
Tachycardia
17%
Chest Tightness
17%
Swelling of Extremity
13%
Dry Mouth
13%
Influenza
13%
Joint Pain
13%
Back Pain
13%
Cough
8%
Hypotension
8%
Hyperglycemia
8%
Muscle Strain
8%
Wheezing
8%
Increased Respiratory Rate
4%
Bradycardia
4%
Eczema
4%
Chest Cold
4%
Systolic Murmur
4%
Heartburn
4%
Diarrhea
4%
Hand,Food, and mouth
4%
Chills
4%
Abscess of tooth
4%
Cirrhosis
4%
Hypoglycemia
4%
Gout Flare
4%
Bibasilar Crackles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Nitrite
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sodium NitriteExperimental Treatment1 Intervention
Study
Group II: PlaceboPlacebo Group1 Intervention
Control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Nitrite
2017
Completed Phase 2
~290

Find a Location

Who is running the clinical trial?

Gladwin, Mark, MDLead Sponsor
14 Previous Clinical Trials
386 Total Patients Enrolled
3 Trials studying Heart Failure
113 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,933 Previous Clinical Trials
47,791,003 Total Patients Enrolled
209 Trials studying Heart Failure
677,706 Patients Enrolled for Heart Failure
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,590 Total Patients Enrolled
14 Trials studying Heart Failure
2,899 Patients Enrolled for Heart Failure
~4 spots leftby Nov 2025
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