Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Disease, Heart Failure With Preserved Ejection Fraction, Exercise Intolerance, Pulmonary Hypertension

In brief

Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study assessed the effects of acute nitrite administration on resting and exercise hemodynamics in patients with HFpEF.

Key facts

Study ID

NCT01932606

Run by

Barry Borlaug

People needed

28

Starts

2013-08-01

Expected to finish

2014-10-01

Last updated by the study team

2016-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo a cardiac catheterization procedure.
• Clinical symptoms of shortness of breath and fatigue
• Normal left ventricular ejection fraction (≥50%)
• Elevated left ventricular filling pressures at cardiac catheterization (defined as resting pulmonary capillary wedge pressure (PCWP)>15 mmHg and/or PCWP≥25 mmHg during exercise)

You may not qualify if…

• Systolic BP <120 mmHg
• 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, constrictive pericarditis, or infiltrative, restrictive, or hypertrophic cardiomyopathies

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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