Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: Aires Pharmaceuticals, Inc.; National Heart, Lung, and Blood Institute (NHLBI)

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 <120 mmHg (during catheterization)

• Prior nitrate therapy (within previous 2 weeks)

• Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency

• Other "non-HFpEF" specific causes of heart failure such as significant valvular disease (>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