Phase 2 N=26 Randomized Quadruple-blind Diagnostic

Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT02262078 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2017

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

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sodium Nitrite Inhalation Solution (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Dec 2015

Outcome Measures

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

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.

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

View full record on ClinicalTrials.gov →

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.