Inhaled Sodium Nitrite on Heart Failure with Preserved Ejection Fraction

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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
  • Prior nitrate therapy (within previous 2 weeks)
  • 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
  • Constrictive pericarditis, or infiltrative, restrictive, or hypertrophic cardiomyopathies, pregnancy.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Barry Borlaug, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20144039

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