Phase 2 Completed N=26 Randomized Quadruple-blind Diagnostic

Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction

Source: ClinicalTrials.gov NCT02262078 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcomePrimary: Change in Pulmonary Capillary Wedge Pressure During Exercise — -1; -4 millimeters of mercury — p=0.002

Summary

Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study will assess the effects of nebulized inhaled nitrite administration on resting and exercise hemodynamics in patients with HFpEF referred to the catheterization lab.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pulmonary Capillary Wedge Pressure During Exercise	-1; -4	0.002 sig

Eligibility Criteria

Inclusion Criteria

Heart Failure with preserved Ejection Fraction (HFpEF) is defined by clinical symptoms of dyspnea and fatigue
Normal left ventricular ejection fraction (>/=50%)
And elevated Left Ventricular (LV) filling pressure at cardiac catheterization (defined as resting Pulmonary Capillary Wedge Pressure (PCWP)>15 mmHg and/or PCWP >/=25 mmHg during exercise).

Exclusion Criteria

Systolic Blood Pressure moderate left-sided regurgitation, >mild stenosis)
Severe pulmonary disease
Unstable coronary disease or coronary spasm
Primary renal or hepatic disease (end stage renal failure/on dialysis or clinical diagnosis of hepatitis or hepatic cirrhosis)
Constrictive pericarditis, or infiltrative, restrictive, or hypertrophic cardiomyopathies
Pregnant

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Data sourced from ClinicalTrials.gov (NCT02262078). 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. Informational only — not medical advice.