Phase 2
N=28
Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction
Heart Disease · Heart Failure With Preserved Ejection Fraction · Exercise Intolerance · Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01932606 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Exercise Pulmonary Capillary Wedge Pressure (PCWP) — 19.0; 28.0 mm Hg — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nitrite (Drug); Saline Placebo for Nitrite (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Barry Borlaug
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Pulmonary Capillary Wedge Pressure (PCWP) |
19.0; 28.0 | 0.0003 sig |
| SECONDARY Change in Central Pressures After Study Drug (Resting) |
-2; 0; -8; -3; -6; -1 | 0.0003 sig |
| SECONDARY Change in Heart Rate After Study Drug (Resting) |
0; -3 | 0.15 |
| SECONDARY Change in Blood Pressure After Study Drug (Resting) |
-7; -2; -3; -1 | 0.11 |
| SECONDARY Change in Pulmonary Vascular Resistance (PVR) After Study Drug (Resting) |
-0.3; -0.4 | 0.7 |
| SECONDARY Change in Pulmonary Artery (PA) Compliance After Study Drug (Resting) |
0.8; 0.2 | 0.1 |
| SECONDARY Change in Systemic Vascular Resistance (SVR) After Study Drug (Resting) |
140; 20 | 0.3 |
| SECONDARY Change in Left Ventricular Stroke Work (LVSW) After Study Drug (Resting) |
-6; 0 | 0.3 |
| SECONDARY Change in Oxygen Consumption (VO_2) After Study Drug (Resting) |
-2; -6 | 0.8 |
| SECONDARY Change in Arteriovenous Oxygen Content Difference After Study Drug (Resting) |
0.4; 0 | 0.1 |
| SECONDARY Change in Cardiac Output After Study Drug (Resting) |
-0.4; -0.2 | 0.4 |
| SECONDARY Change in Stroke Volume After Study Drug (Resting) |
-5; -1 | 0.4 |
| SECONDARY Change in Central Pressures After Study Drug (Exercise) |
-5; -1; -11; -4; 10; -2 | 0.0002 sig |
| SECONDARY Change in Heart Rate After Study Drug (Exercise) |
-1; 0 | 0.3 |
| SECONDARY Change in Blood Pressure After Study Drug (Exercise) |
-5; 2; -5; 0 | 0.2 |
| SECONDARY Change in PVR After Study Drug (Exercise) |
0; 0.2 | 0.3 |
| SECONDARY Change in PA Compliance After Study Drug (Exercise) |
0.8; 0.5 | 0.3 |
| SECONDARY Change in SVR After Study Drug (Exercise) |
-70; 70 | 0.007 sig |
| SECONDARY Change in LVSW After Study Drug (Exercise) |
15; -2 | 0.0003 sig |
| SECONDARY Change in Oxygen Consumption (VO_2) After Study Drug (Exercise) |
70; -30 | 0.02 sig |
| SECONDARY Change in Arteriovenous Oxygen Difference After Study Drug (Exercise) |
0.2; 0 | 0.6 |
| SECONDARY Change in Cardiac Output After Study Drug (Exercise) |
0.5; -0.4 | 0.002 sig |
| SECONDARY Change in Stroke Volume After Study Drug (Exercise) |
7; -5 | 0.0002 sig |
Summary
Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study assessed the effects of acute nitrite administration on resting and exercise hemodynamics in patients with HFpEF.
Eligibility Criteria
Inclusion Criteria
- Scheduled to undergo a cardiac catheterization procedure.
- Clinical symptoms of shortness of breath and fatigue
- Normal left ventricular ejection fraction (≥50%)
- Elevated left ventricular filling pressures at cardiac catheterization (defined as resting pulmonary capillary wedge pressure (PCWP)>15 mmHg and/or PCWP≥25 mmHg during exercise)
Exclusion Criteria
- Systolic BP moderate left-sided regurgitation, >mild stenosis), severe pulmonary disease, unstable coronary disease or coronary spasm, primary renal or hepatic disease, constrictive pericarditis, or infiltrative, restrictive, or hypertrophic cardiomyopathies
Data sourced from ClinicalTrials.gov (NCT01932606). 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.