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Inorganic Nitrate

Sodium Nitrite for Pulmonary Hypertension (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 (i.e. the 10th week of placebo vs 10th week of nitrite)
Awards & highlights

PH-HFpEF Trial Summary

This trial will compare the effects of oral inorganic nitrite to placebo in patients with PH-HFpEF. The goal is to see if nitrite can improve exercise tolerance in these patients.

Eligible Conditions
  • Pulmonary Hypertension
  • Heart Failure

PH-HFpEF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks (i.e. the 10th week of placebo vs 10th week of nitrite)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks (i.e. the 10th week of placebo vs 10th week of nitrite) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pulmonary artery pressure (mPAP) during submaximal exercise as compared between placebo and nitrite
Secondary outcome measures
Change in endurance exercise time
Change in right heart catheterization (RHC) hemodynamics
Change in severity of heart failure
+1 more

Side effects data

From 2013 Phase 1 & 2 trial • 33 Patients • NCT02022670
20%
fatigue
10%
dizziness/light-headedness
10%
asymptomatic orthostatic hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sodium Nitrite 80 mg/d
Sodium Nitrite 160 mg/d

PH-HFpEF Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sodium NitriteExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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
400 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,851,015 Total Patients Enrolled
Michael Risbano, MD, MAPrincipal Investigator - University of Pittsburgh
University of Pittsburgh
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

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

What other scientific papers have been published on Sodium Nitrite?

"There are 4 ongoing clinical trials evaluating the efficacy of sodium nitrite. Of these, none have reached Phase 3. The majority of research locations for this study are situated in Bronx, New york; however, there are 7 total research sites."

Answered by AI

How many people fit the bill for this experiment?

"As of now, this study is not seeking new participants. However, this could change in the future as the trial was last edited on 10/24/2022. There are 1506 trials for heart failure and 4 studies concerning Sodium Nitrite that are actively enrolling participants if you are looking for other medical research opportunities."

Answered by AI

Are we still looking for participants for this research?

"This study, according to the information available on clinicaltrials.gov, is not currently looking for participants. The trial was first posted on 10/30/2017 and was most recently edited on 10/24/2022. Although this study is not looking for candidates anymore, there are 1510 other trials presently looking for patients right now."

Answered by AI

Is this a groundbreaking clinical trial?

"There are currently 4 live trials for Sodium Nitrite being conducted in 2 cities and 1 country. The earliest study for Sodium Nitrite was performed in 2016 by Mast Therapeutics, Inc. 57 studies have been completed since then."

Answered by AI

Has Sodium Nitrite been federally mandated for use?

"There is some data supporting Sodium Nitrite's safety, but none yet for efficacy. It received a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Michael Risbano 2017. "Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03015402.
~4 spots leftby Apr 2025
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