Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction
Acute Effects of Inhaled Sodium Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction
3 other identifiers
interventional
26
1 country
1
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 administration on resting and exercise hemodynamics in patients with HFpEF referred to the catheterization lab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 heart-failure
Started Oct 2014
Shorter than P25 for phase_2 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
January 19, 2017
CompletedAugust 29, 2017
July 1, 2017
1.2 years
September 30, 2014
November 21, 2016
July 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Pulmonary Capillary Wedge Pressure During Exercise
Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured in millimeters of mercury (mmHg)
Baseline, after study drug dosing, approximately 4 minutes after starting exercise
Study Arms (2)
Placebo (Saline)
PLACEBO COMPARATORParticipants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer
Sodium Nitrite
EXPERIMENTALParticipants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer
Interventions
90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise.
Normal saline will be administered (by inhalation) to participants prior to exercise.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Aires Pharmaceuticals, Inc.collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Publications (2)
Borlaug BA, Melenovsky V, Koepp KE. Inhaled Sodium Nitrite Improves Rest and Exercise Hemodynamics in Heart Failure With Preserved Ejection Fraction. Circ Res. 2016 Sep 16;119(7):880-6. doi: 10.1161/CIRCRESAHA.116.309184. Epub 2016 Jul 25.
PMID: 27458234RESULTReddy YNV, Stewart GM, Obokata M, Koepp KE, Borlaug BA. Peripheral and pulmonary effects of inorganic nitrite during exercise in heart failure with preserved ejection fraction. Eur J Heart Fail. 2021 May;23(5):814-823. doi: 10.1002/ejhf.2093. Epub 2021 Feb 1.
PMID: 33421267DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Patients with symptoms that might independently cause symptoms were excluded, including severe valvular or coronary heart disease and advanced lung, liver or kidney disease. Cannot determine if results would apply to these co-morbidities.
Results Point of Contact
- Title
- Barry A. Borlaug, MD
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Barry Borlaug, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 30, 2014
First Posted
October 10, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 29, 2017
Results First Posted
January 19, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share