Trial Outcomes & Findings for Dietary Nitrate for Heart Failure (NCT NCT01682356)

NCT ID: NCT01682356

Last Updated: 2024-12-04

Results Overview

Maximal power of the quadriceps muscle group as measured using isokinetic dynamometry

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 2-3 h after acute dose of beetroot juice containing or essentially devoid of nitrate
• Results posted on: 2024-12-04

Participant Flow

Participant milestones

Measure	Placebo Then Nitrate Acute (single dose) placebo, 7 day washout, acute (single dose) nitrate	Nitrate Then Placebo Acute (single dose) nitrate, 7 day washout, acute (single dose) placebo
Overall Study STARTED	10	7
Overall Study COMPLETED	10	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dietary Nitrate for Heart Failure

Baseline characteristics by cohort

Measure	Placebo Then Nitrate n=10 Participants Placebo then nitrate	Nitrate Then Placebo n=7 Participants Nitrate then placebo	Total n=17 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 12 • n=5 Participants	57 years STANDARD_DEVIATION 12 • n=7 Participants	55 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-3 h after acute dose of beetroot juice containing or essentially devoid of nitrate

Population: Only 9 participants were assessed for maximal knee extensor power.

Maximal power of the quadriceps muscle group as measured using isokinetic dynamometry

Outcome measures

Measure	Placebo n=9 Participants Beetroot juice without nitrate.	Nitrate n=9 Participants Beetroot juice with nitrate.
Maximal Knee Extensor Power	4.20 W/kg Standard Error 0.33	4.74 W/kg Standard Error 0.41

SECONDARY outcome

Timeframe: 2-3 h after acute dose of beetroot juice containing or essentially devoid of nitrate

Population: Only 8 participants were assessed for VO2peak.

Peak oxygen consumption as measured during semi-recumbent cycle ergometer exercise

Outcome measures

Measure	Placebo n=8 Participants Beetroot juice without nitrate.	Nitrate n=8 Participants Beetroot juice with nitrate.
VO2peak	21.4 mL/min/kg Standard Error 2.1	23.0 mL/min/kg Standard Error 2.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 h

Nitrate in plasma before ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Baseline Plasma Nitrate	27 umol/L Standard Error 4	31 umol/L Standard Error 4

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 h

Nitrate in plasma 1 h after ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Plasma Nitrate @ 1 h	25 umol/L Standard Error 3	334 umol/L Standard Error 31

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 h

Nitrate in plasma 2 h after ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Plasma Nitrate @ 2 h	24 umol/L Standard Error 3	386 umol/L Standard Error 172

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 min post-exercise

Nitric oxide in breath 10 min after completion of exercise testing

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Plasma Nitrate @ 10 Min Post-exercise	25 umol/L Standard Error 3	397 umol/L Standard Error 45

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 h

Nitrite in plasma before ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Baseline Plasma Nitrite	0.292 umol/L Standard Error 0.070	0.341 umol/L Standard Error 0.146

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 h

Nitrite in plasma 1 h after ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Plasma Nitrite @ 1 h	0.254 umol/L Standard Error 0.064	0.298 umol/L Standard Error 0.085

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 h

Nitrite in plasma 1 h after ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Plasma Nitrite @ 2 h	0.216 umol/L Standard Error 0.050	0.315 umol/L Standard Error 0.059

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 min post-exercise

Nitrite in plasma 10 min after completion of exercise testing

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Plasma Nitrite @ 10 Min Post-exercise	0.306 umol/L Standard Error 0.083	0.400 umol/L Standard Error 0.093

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 h

Nitric oxide in breath before ingestion of beetroot juice

Outcome measures

Measure	Placebo n=15 Participants Beetroot juice without nitrate.	Nitrate n=15 Participants Beetroot juice with nitrate.
Baseline Breath Nitric Oxide	18 ppm Standard Error 1	20 ppm Standard Error 2

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 h

Nitric oxide in breath 1 h after ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=15 Participants Beetroot juice with nitrate.
Breath Nitric Oxide @ 1 h	19 ppm Standard Error 2	29 ppm Standard Error 3

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 h

Nitric oxide in breath 2 h after ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=15 Participants Beetroot juice with nitrate.
Breath Nitric Oxide @ 2 h	19 ppm Standard Error 2	31 ppm Standard Error 3

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 min post

Nitric oxide in breath 10 min after completion of exercise testing

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=15 Participants Beetroot juice with nitrate.
Breath Nitric Oxide @ 10 Min Post-exercise	17 ppm Standard Error 1	27 ppm Standard Error 3

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 h

Systolic blood pressure before ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Baseline Systolic Blood Pressure	106 mmHg Standard Error 4	109 mmHg Standard Error 4

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 h

Systolic blood pressure 1 h after ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Systolic Blood Pressure @ 1 h	104 mmHg Standard Error 4	109 mmHg Standard Error 3

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 h

Systolic blood pressure 2 h after ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Systolic Blood Pressure @ 2 h	104 mmHg Standard Error 3	106 mmHg Standard Error 4

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 min post-exercise

Systolic blood pressure 10 min after completion of exercise testing

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Systolic Blood Pressure @ 10 Min Post-exercise	111 mmHg Standard Error 4	106 mmHg Standard Error 3

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 h

Diastolic blood pressure before ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Baseline Diastolic Blood Pressure	68 mmHg Standard Error 3	71 mmHg Standard Error 3

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 h

Diastolic blood pressure 1 h after ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Diastolic Blood Pressure @ 1 h	66 mmHg Standard Error 3	68 mmHg Standard Error 2

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 h

Diastolic blood pressure 2 h after ingestion of beetroot juice

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Diastolic Blood Pressure @ 2 h	67 mmHg Standard Error 3	68 mmHg Standard Error 2

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 min post-exercise

Diastolic blood pressure 10 min after completion of exercise testing

Outcome measures

Measure	Placebo n=17 Participants Beetroot juice without nitrate.	Nitrate n=17 Participants Beetroot juice with nitrate.
Diastolic Blood Pressure @ 10 Min Post-exercise	69 mmHg Standard Error 3	69 mmHg Standard Error 2

OTHER_PRE_SPECIFIED outcome

Timeframe: after ingestion of BRJ or placebo

Subjects undergoing MRI or echocardiography will have various measures of cardiac function made

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day intervention

Each patient who is going to have a PA catheter placed for clinical purposes will have their PA pressures measured before and after ingestion of BRJ.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: each patient will undergo a study for a maximum of ~ 2 weeks

Each subject undergoes a laser Doppler test and a brachial artery test after ingesting BRJ or placebo. There is a 10 d washout period and then the test is repeated after the subject ingests the BRJ or placebo (whichever was not taken the first time).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: before and after BRJ or placebo ingestion

We will measure perfusion using noninvasive PET imaging

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: after BRJ or placebo ingestion

We will measure cyclic GMP and nitrate in LV tissue after LVAD placement and after ingestion of either BRJ or placebo

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nitrate

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

Linda R. Peterson, MD

Washington University School of Medicine

Phone: 314-362-4577

Email: lpeterso@wustl.edu

Results disclosure agreements

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