Trial Outcomes & Findings for Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction (NCT NCT02262078)

NCT ID: NCT02262078

Last Updated: 2017-08-29

Results Overview

Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured in millimeters of mercury (mmHg)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 26 participants
• Primary outcome timeframe: Baseline, after study drug dosing, approximately 4 minutes after starting exercise
• Results posted on: 2017-08-29

Participant Flow

Participants were referred to the Rochester, Minnesota Mayo Clinic cardiac catheterization laboratory for invasive hemodynamic exercise stress testing between December 2014 and December 2015.

Of 70 patients screened, 32 were excluded based upon entry criteria and 12 were excluded based on hemodynamic criteria for Heart Failure with preserved Ejection Fraction (HFpEF) (n=10) or because arterial pressures were too low (n=2).

Participant milestones

Measure	Placebo (Saline) Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise.	Sodium Nitrite Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise.
Overall Study STARTED	13	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction

Baseline characteristics by cohort

Measure	Sodium Nitrite n=13 Participants Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise.	Total n=26 Participants Total of all reporting groups	Placebo (Saline) n=13 Participants Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise.
Age, Continuous	67 years STANDARD_DEVIATION 9 • n=7 Participants	70 years STANDARD_DEVIATION 10 • n=5 Participants	72 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	6 Participants n=7 Participants	14 Participants n=5 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=7 Participants	12 Participants n=5 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=7 Participants	26 Participants n=5 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=7 Participants	26 participants n=5 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, after study drug dosing, approximately 4 minutes after starting exercise

Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured in millimeters of mercury (mmHg)

Outcome measures

Measure	Placebo (Saline) n=13 Participants Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise.	Sodium Nitrite n=13 Participants Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise.
Change in Pulmonary Capillary Wedge Pressure During Exercise	-1 millimeters of mercury Standard Deviation 2	-4 millimeters of mercury Standard Deviation 3

Adverse Events

Placebo (Saline)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sodium Nitrite

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo (Saline) n=13 participants at risk Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise.	Sodium Nitrite n=13 participants at risk Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise.
Cardiac disorders Vasovagal syncope	7.7% 1/13 • Number of events 1 • From baseline to X hours following treatment.	0.00% 0/13 • From baseline to X hours following treatment.
General disorders Taste perversion	0.00% 0/13 • From baseline to X hours following treatment.	7.7% 1/13 • Number of events 1 • From baseline to X hours following treatment.

Additional Information

Barry A. Borlaug, MD

Mayo Clinic

Email: Borlaug.Barry@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place