Phase 2
N=24
Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension Secondary · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03015402 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and Nitrite — 48.75; 48.68; 56.81; 55.0 mmHg — p=0.20
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sodium Nitrite (Drug); Placebo Oral Capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and Nitrite |
48.75; 48.68; 56.81; 55.0 | 0.20 |
| SECONDARY Difference in 6-minute Walk Test |
269.5; 253.2; 267.6; 255.2 | — |
| SECONDARY Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Capillary Wedge Pressure |
28.2; 26.3; 29.9; 28.4 | — |
| SECONDARY Change in Severity of Heart Failure |
4146.055; 4215.096 | — |
| SECONDARY Change in Right Heart Catheterization (RHC) Hemodynamics - Trans Pulmonary Gradient |
20.6; 22.6; 27.1; 26.6 | — |
| SECONDARY Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Vascular Resistance |
3.2; 3.2; 3.4; 2.9 | — |
| SECONDARY Change in Right Heart Catheterization (RHC) Hemodynamics - Cardiac Output |
8.1; 8.8; 9.4; 10 | — |
| SECONDARY Number of Participants With Different Severities of Heart Failure |
2; 1; 8; 5; 6; 9 | — |
| SECONDARY Change in Endurance Exercise Time |
-0.056; -0.904 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
Age 18 years and older
PH-HFpEF confirmed diagnosis by RHC:
- Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg AND
- Pulmonary capillary wedge pressure (PWCP) ≥ 15 mmHg AND
- Transpulmonary Gradient (TPG) ≥ 12 mmHg
Exclusion Criteria
- Age less than 18 years;
- SBP > 170 or 95 or 10
- Positive urine pregnancy test or breastfeeding;
- Ejection Fraction (EF) 3.0 mg/dL
- Receipt of an investigational product or device, or participation in a drug research study within a period of 15 days; RHC < 2 weeks from study screening RHC unless clinically indicated
Data sourced from ClinicalTrials.gov (NCT03015402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.