Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-004077
NCT ID: NCT01932606
Sponsor Protocol Number: 13-004077
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 acute 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:
- 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 PCWP>15 mmHg and/or PCWP≥25 mmHg during exercise)
Exclusion Criteria:
- Systolic BP <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
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