Trial Outcomes & Findings for Inorganic NItrate and EXercise Performance in Heart Failure (iNIX-HF): Dose Response (NCT NCT02797184)
NCT ID: NCT02797184
Last Updated: 2025-05-20
Results Overview
peak oxygen consumption during treadmill exercise
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
42 participants
Primary outcome timeframe
acute - 2.5 hours post dose
Results posted on
2025-05-20
Participant Flow
Participant milestones
| Measure |
10mmol KNO3, Then 20mmol KNO3
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10mmol KNO3) in 2 gelatin capsules during dose visit 1 and the otherv20 mmol KNO3 during dose visit 2.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
|
20mmol KNO3, Then 10mmol KNO3
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and 10mmol KNO3 during dose visit 2.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
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|---|---|---|
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Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
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3
|
3
|
|
Overall Study
NOT COMPLETED
|
18
|
18
|
Reasons for withdrawal
| Measure |
10mmol KNO3, Then 20mmol KNO3
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10mmol KNO3) in 2 gelatin capsules during dose visit 1 and the otherv20 mmol KNO3 during dose visit 2.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
|
20mmol KNO3, Then 10mmol KNO3
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and 10mmol KNO3 during dose visit 2.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
|
|---|---|---|
|
Overall Study
Study was put on hold due to COVID-19. Could not finish these subjects before funding ran out.
|
18
|
18
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Baseline Characteristics
Inorganic NItrate and EXercise Performance in Heart Failure (iNIX-HF): Dose Response
Baseline characteristics by cohort
| Measure |
All Study Participants
n=6 Participants
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10 or 20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and the other dose (10 or 20 mmol KNO3) during dose visit 2. The dose order will be randomized.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
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1 Participants
n=99 Participants
|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: acute - 2.5 hours post dosepeak oxygen consumption during treadmill exercise
Outcome measures
| Measure |
10mmol KNO3
n=6 Participants
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10 or 20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and the other dose (10 or 20 mmol KNO3) during dose visit 2. The dose order will be randomized.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
|
20mmol KNO3
n=6 Participants
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10 or 20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and the other dose (10 or 20 mmol KNO3) during dose visit 2. The dose order will be randomized.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
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|---|---|---|
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VO2peak
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17.7 mL/kg/min
Standard Deviation 3.4
|
18.0 mL/kg/min
Standard Deviation 4.1
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SECONDARY outcome
Timeframe: acute - 2 hours post doseParticipants completed measurements of leg muscle power by doing knee extension exercises on a dynamometer (a device that measures voluntary muscle force production while controlling the speed of movement).
Outcome measures
| Measure |
10mmol KNO3
n=6 Participants
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10 or 20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and the other dose (10 or 20 mmol KNO3) during dose visit 2. The dose order will be randomized.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
|
20mmol KNO3
n=6 Participants
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10 or 20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and the other dose (10 or 20 mmol KNO3) during dose visit 2. The dose order will be randomized.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
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|---|---|---|
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Peak Muscle Power
|
469.4 Watts/kg
Standard Deviation 188.8
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497.9 Watts/kg
Standard Deviation 173.8
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SECONDARY outcome
Timeframe: time 0 (before receiving the KNO3 dose) and hourly after receiving KNO3 (1, 2, and 3 hours post-dose)concentrations of nitrite in the blood
Outcome measures
| Measure |
10mmol KNO3
n=6 Participants
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10 or 20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and the other dose (10 or 20 mmol KNO3) during dose visit 2. The dose order will be randomized.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
|
20mmol KNO3
n=6 Participants
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10 or 20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and the other dose (10 or 20 mmol KNO3) during dose visit 2. The dose order will be randomized.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
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|---|---|---|
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Blood Nitrite Levels
0 hr
|
0.489 micro M
Standard Deviation 0.295
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0.432 micro M
Standard Deviation 0.258
|
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Blood Nitrite Levels
1 hr post-ingestion KNO3
|
0.568 micro M
Standard Deviation 0.244
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0.591 micro M
Standard Deviation 0.481
|
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Blood Nitrite Levels
2 hr post-ingestion KNO3
|
0.658 micro M
Standard Deviation 0.277
|
0.864 micro M
Standard Deviation 0.916
|
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Blood Nitrite Levels
3 hr post-ingestion KNO3
|
0.646 micro M
Standard Deviation 0.261
|
0.769 micro M
Standard Deviation 0.529
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SECONDARY outcome
Timeframe: time 0 (before receiving the KNO3 dose) and hourly after receiving KNO3 (1, 2, and 3 hours post-dose)Breath nitric oxide (NO) level will be taken via NIOX breath analyzer
Outcome measures
| Measure |
10mmol KNO3
n=4 Participants
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10 or 20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and the other dose (10 or 20 mmol KNO3) during dose visit 2. The dose order will be randomized.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
|
20mmol KNO3
n=4 Participants
Intervention: Subjects with heart failure will receive a single oral dose of potassium nitrate (10 or 20 mmol KNO3) in 2 gelatin capsules during dose visit 1 and the other dose (10 or 20 mmol KNO3) during dose visit 2. The dose order will be randomized.
KNO3, potassium nitrate: Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
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|---|---|---|
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Breath Nitric Oxide (NO) Level
0 hr
|
26 ppb
Standard Deviation 13
|
23 ppb
Standard Deviation 9
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Breath Nitric Oxide (NO) Level
1 hr
|
28 ppb
Standard Deviation 11
|
30 ppb
Standard Deviation 14
|
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Breath Nitric Oxide (NO) Level
2 hr
|
28 ppb
Standard Deviation 9
|
36 ppb
Standard Deviation 21
|
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Breath Nitric Oxide (NO) Level
3 hr
|
32 ppb
Standard Deviation 7
|
43 ppb
Standard Deviation 16
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Adverse Events
10mmol KNO3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
20mmol KNO3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place