Status:
COMPLETED
Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Aires Pharmaceuticals, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 administ...
Detailed Description
Patients referred to the cardiac catheterization laboratory for invasive exercise stress testing will be prospectively recruited. Standard right heart catheterization using high fidelity micromanomete...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02262078
Start Date
October 1 2014
End Date
December 1 2015
Last Update
August 29 2017
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905