Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF)
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ClinicalTrials.gov Identifier: NCT02742129 |
Recruitment Status :
Completed
First Posted : April 18, 2016
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Heart Failure |
Interventions |
Drug: Nebulized Sodium Nitrite Drug: Placebo |
Enrollment | 105 |
Recruitment Details | Patients with a diagnosis of HFpEF are screened for entry criteria. Willing participants meeting entry criteria will be consented and questioned to confirm that HF symptoms are the primary limitation to activity. |
Pre-assignment Details | All consented participants continuing to meet the screening criteria will undergo a baseline HFN study-specific CPET to confirm Peak VO2 ≤75% with peak respiratory exchange ratio ≥ 1.0. All subjects that fulfill the CPET and other inclusion criteria and none of the exclusion criteria will be randomized. |
Arm/Group Title | AIR001 Crossover to Placebo | Placebo Crossover to AIR001 |
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Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug Nebulized Sodium Nitrite (AIR001) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Placebo instead of AIR001. | Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug (Placebo) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Nebulized Sodium Nitrite (AIR001) instead of Placebo. |
Period Title: Phase 1 | ||
Started | 53 | 52 |
Completed | 51 | 50 |
Not Completed | 2 | 2 |
Period Title: Phase 2 | ||
Started | 51 | 50 |
Completed | 50 | 48 |
Not Completed | 1 | 2 |
Arm/Group Title | AIR001 Crossover to Placebo | Placebo Crossover to AIR001 | Total | |
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Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug Nebulized Sodium Nitrite (AIR001) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Placebo instead of AIR001. Nebulized Sodium Nitrite: Inhaled, nebulized inorganic sodium nitrite vs. inhaled, nebulized placebo at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day. Placebo: Inhaled, nebulized placebo vs. inhaled, nebulized inorganic sodium nitrite at a dose of 80 mg (or maximally to |
Phase 1: Participants will wear an accelerometer device daily but take no study drug for 14 days (washout period). On day 15, participants begin phase I study drug (Placebo) at 46 mg, at minimum of 4 hours apart, for 3 doses per day during the active portion of the participant's day. On day 22 participants increase study drug dose to 80 mg at the same frequency. Regardless of participant's ability to tolerate study drug or if the participant requires down-titration, participants will begin Phase 2. Phase 2: Is identical to Phase 1 except subject will be taking Nebulized Sodium Nitrite (AIR001) instead of Placebo. Nebulized Sodium Nitrite: Inhaled, nebulized inorganic sodium nitrite vs. inhaled, nebulized placebo at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day. Placebo: Inhaled, nebulized placebo vs. inhaled, nebulized inorganic sodium nitrite at a dose of 80 mg (or maximally |
Total of all reporting groups | |
Overall Number of Baseline Participants | 53 | 52 | 105 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 53 participants | 52 participants | 105 participants | |
67.8 (8.5) | 67.5 (11.6) | 67.7 (10.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 53 participants | 52 participants | 105 participants | |
Female |
36 67.9%
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23 44.2%
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59 56.2%
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Male |
17 32.1%
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29 55.8%
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46 43.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 53 participants | 52 participants | 105 participants | |
Hispanic or Latino |
0 0.0%
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1 1.9%
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1 1.0%
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Not Hispanic or Latino |
53 100.0%
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51 98.1%
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104 99.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 53 participants | 52 participants | 105 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
6 11.3%
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7 13.5%
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13 12.4%
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White |
47 88.7%
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45 86.5%
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92 87.6%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Name/Title: | Adrian Hernandez |
Organization: | Duke Clinical Research Institute |
Phone: | 919-668-7515 |
EMail: | Adrian.Hernandez@duke.edu |
Responsible Party: | Adrian Hernandez, Duke University |
ClinicalTrials.gov Identifier: | NCT02742129 |
Other Study ID Numbers: |
Pro00071526 5U10HL084904 ( U.S. NIH Grant/Contract ) |
First Submitted: | April 8, 2016 |
First Posted: | April 18, 2016 |
Results First Submitted: | December 6, 2018 |
Results First Posted: | March 13, 2019 |
Last Update Posted: | March 13, 2019 |