Inorganic NItrate and EXercise Performance in Heart Failure (iNIX-HF): Dose Response
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|ClinicalTrials.gov Identifier: NCT02797184|
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: KNO3, potassium nitrate||Phase 1 Phase 2|
- Subjects will be patients with Heart Failure (HF).
- All subjects will be consented.
- All subjects will give permission for the investigators to review their medical records.
- After consenting to participate, subjects will be instructed to refrain from spitting or the use of an antibacterial mouthwash, antacids, proton pump inhibitors, or chewing gum during the morning of each clinic visit.
- Subjects will have a physical examination.
- Subjects will undergo transthoracic echocardiographic imaging at rest (unless they had this performed within the past 6 months).
- Subjects will be asked to undergo a mouth swab for bacterial DNA analyses.
- Subjects will be asked to answer questionnaires regarding their medical health (basic health questionnaire, Minnesota living with heart failure questionnaire, a combined fatigue questionnaire.
- Dose visit 1: Subjects will receive 2 capsules containing either 10 or 20 mmol of potassium nitrate (KNO3).
- Before and at 3 hourly time points after receiving the KNO3, subjects will undergo phlebotomy for plasma nitrate and nitrite levels, will have their blood pressure measured, and will blow into a small machine to assess the amount of nitric oxide in their breath.
- Exercise Test 1: Subjects will complete 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).
- Exercise Test 2: Subjects complete a measurement of peak aerobic capacity (VO2peak) while walking on a treadmill and breathing into a mouthpiece. Blood pressure, heart rate and heart rhythm will be monitored during this test.
- Subjects will undergo a 7 d washout period.
- Dose visit 2: Subjects will receive 2 capsules containing either 10 or 20 mmol of KNO3 (whichever dose they did not receive at dose visit 1). They will repeat the same assessments listed above in 10, 11, and 12.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects will receive one drug dose on the first dose visit and the second drug dose on the second dose visit. The order of the two drug doses (10 and 20 mmol KNO3) will be randomized, so that some subjects will receive the lower dose first and others will receive the higher dose first|
|Masking:||None (Open Label)|
|Masking Description:||Both the participant and the investigator will be masked to which KNO3 dose is administered at each visit. However, it is known at the outset that each patient will receive 10 mmol KNO3 during one visit and 20 mmol KNO3 at another visit, with the order randomly assigned.|
|Official Title:||Inorganic NItrate and EXercise Performance in Heart Failure (iNIX-HF): Dose Response|
|Actual Study Start Date :||October 31, 2017|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Aim 1. KNO3 dose response
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.
Drug: 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.
Other Name: saltpeter
- VO2peak [ Time Frame: acute - 2.5 hours post dose ]peak oxygen consumption during treadmill exercise
- Peak muscle power [ Time Frame: acute - 2 hours post dose ]assessment of quadriceps power
- Blood nitrate and blood nitrite levels [ Time Frame: time 0 (before receiving the KNO3 dose) and hourly after receiving KNO3 (1, 2, and 3 hours post-dose) ]concentrations of nitrate and nitrite in the blood
- Breath nitric oxide (NO) level [ Time Frame: time 0 (before receiving the KNO3 dose) and hourly after receiving KNO3 (1, 2, and 3 hours post-dose) ]breath NO level
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797184
|Contact: Deb Koudelisfirstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Dakkota Thies 314-747-3839 email@example.com|
|Contact: Linda R Peterson, MD 314-362-4577 firstname.lastname@example.org|
|Principal Investigator: Linda R Peterson, MD|
|Sub-Investigator: Andrew R Coggan, PhD|
|Principal Investigator:||Linda R Peterson, MD||Washington University School of Medicine|
|Principal Investigator:||Andrew R Coggan, PhD||Washington University School of Medicine|