18 and older, any sex, with Pulmonary Hypertension Secondary or Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and NitritePrimary· Baseline and 10 weeks
Mean Pulmonary Artery Pressure measurement at submaximal exercise as compared between Placebo and Oral Nitrite at 10 weeks.
Supine Mean Pulmonary Artery Pressure at Baseline
Group
Value
95% CI
Oral Nitrite
48.75
± 11.73
Placebo
48.68
± 11.34
Supine Mean Pulmonary Artery Pressure at 10 Weeks
Group
Value
95% CI
Oral Nitrite
56.81
± 9.87
Placebo
55.0
± 8.10
Difference in 6-minute Walk TestSecondary· Baseline to 10 weeks
The 6-minute walk test measures the distance an individual is able to walk over 6 minutes on a hard, flat surface. The subject is allowed to self-pace and rest as needed.
The number of subjects with available 6-minute walk tests do not match the total number of subjects in the study due to: one subject fracturing a foot and several subjects missing visit timepoints due to health issues resulting in 6 minute walk test not being performed.
Baseline Distance
Group
Value
95% CI
Oral Nitrite
269.5
± 130.3
Placebo
253.2
± 59.7
10 Weeks Distance
Group
Value
95% CI
Oral Nitrite
267.6
± 164.1
Placebo
255.2
± 89.3
Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Capillary Wedge PressureSecondary· During Week 10 follow-up at rest and at exercise
Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Pulmonary Capillary Wedge Pressure are improved over the course of treatment.
Pulmonary Capillary Wedge Pressure (Rest)
Group
Value
95% CI
Oral Nitrite
28.2
± 8.7
Placebo
26.3
± 7.9
Pulmonary Capillary Wedge Pressure (Exercise)
Group
Value
95% CI
Oral Nitrite
29.9
± 11.8
Placebo
28.4
± 10.5
Change in Severity of Heart FailureSecondary· Baseline to Week 10
Determined by N-terminal pro b-type natriuretic peptide (NT-proBNP) plasma levels.
The number of subjects with available NT-proBNP values do not match the total number in the study as several subjects missed visit timepoints due to health issues resulting in NT-proBNP not being obtained.
Group
Value
95% CI
Oral Nitrite
4146.055
± 3357.261
Placebo
4215.096
± 3372.754
Change in Right Heart Catheterization (RHC) Hemodynamics - Trans Pulmonary GradientSecondary· During Week 10 follow-up at rest and at exercise
Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Trans Pulmonary Gradient are improved over the course of treatment.
Trans Pulmonary Gradient (Rest)
Group
Value
95% CI
Oral Nitrite
20.6
± 12.1
Placebo
22.6
± 11.1
Trans Pulmonary Gradient (Exercise)
Group
Value
95% CI
Oral Nitrite
27.1
± 11.2
Placebo
26.6
± 8.4
Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Vascular ResistanceSecondary· During Week 10 follow-up at rest and at exercise
Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Pulmonary Vascular Resistance are improved over the course of treatment.
Pulmonary Vascular Resistance (Rest)
Group
Value
95% CI
Oral Nitrite
3.2
± 2.5
Placebo
3.2
± 2.5
Pulmonary Vascular Resistance (Exercise)
Group
Value
95% CI
Oral Nitrite
3.4
± 2.4
Placebo
2.9
± 1.5
Change in Right Heart Catheterization (RHC) Hemodynamics - Cardiac OutputSecondary· During Week 10 follow-up at rest and at exercise
Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Cardiac Output are improved over the course of treatment.
Cardiac Output (Rest)
Group
Value
95% CI
Oral Nitrite
8.1
± 2.4
Placebo
8.8
± 3.1
Cardiac Output (Exercise)
Group
Value
95% CI
Oral Nitrite
9.4
± 3.1
Placebo
10
± 3.1
Number of Participants With Different Severities of Heart FailureSecondary· 10 weeks
Determined by NYHA functional classification changes. Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
While the change in severity of
Class I
Group
Value
95% CI
Oral Nitrite
2
Placebo
1
Class II
Group
Value
95% CI
Oral Nitrite
8
Placebo
5
Class III
Group
Value
95% CI
Oral Nitrite
6
Placebo
9
Class IV
Group
Value
95% CI
Oral Nitrite
0
Placebo
1
Change in Endurance Exercise TimeSecondary· 10 weeks
The endurance exercise time will be measured from the start of loaded pedaling to volitional exhaustion and the worklaod has returned to unloaded pedaling.
Group
Value
95% CI
Nitrite
-0.056
± 2.526
Placebo
-0.904
± 3.705
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline through study completion, up to 26 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main objective of this study is to determine the clinical efficacy of oral inorganic nitrite verses placebo and the therapeutic response with regards to exercise tolerance in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04289558 — Nitrite Infusion in Children With Malaria
· Phase 1
· withdrawn
NCT04401527 — Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite
· Phase 2
· withdrawn
NCT03331146 — Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass
· Phase 3
· withdrawn
NCT04354051 — The Nitrite and Coronary Flow Study
· Phase 1, PHASE2
· completed
NCT04001283 — Nitrite Effects on Cardiac Muscle in CABG
· Phase 2
· unknown
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pittsburgh
Last refreshed: 7 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03015402.