drugset / Trial / NCT02742129
Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF
Phase 2
Completed
105 enrolled
Adrian Hernandez
Aires Pharmaceuticals, Inc. · collabMassachusetts General Hospital · collabMayo Clinic · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabUniversity of Vermont · collabUniversité de Montréal · collab
RandomizedCrossoverTriple-blindTreatment
Summary
A randomized, double-blind, placebo-controlled crossover study to assess the effect of inorganic nitrite (NO2) on aerobic capacity (peak VO2) after four weeks of dosing. Approximately 100 participants will be enrolled in this 2\*2 crossover study.
Timeline
- Start
- 2016-08-10
- Primary completion
- 2017-12-13
- Completion
- 2017-12-27
Outcome
Missed primary endpoint
registry p = 0.2650; Mean Difference (Final Values) -0.20 (95% CI -0.56 to 0.16) NCT02742129 ↗
paper there was no significant difference in mean peak oxygen consumption as compared with the placebo phase PMID 30398602 ↗
Publications
- Reddy YNV, Rikhi A, Obokata M, Shah SJ, Lewis GD, AbouEzzedine OF, Dunlay S, McNulty S, Chakraborty H, Stevenson LW, Redfield MM, Borlaug BA. Quality of life in heart failure with preserved ejection fraction: importance of obesity, functional capacity, and physical inactivity. Eur J Heart Fail. 2020 Jun;22(6):1009-1018. doi: 10.1002/ejhf.1788. Epub 2020 Mar 9.
- Borlaug BA, Anstrom KJ, Lewis GD, Shah SJ, Levine JA, Koepp GA, Givertz MM, Felker GM, LeWinter MM, Mann DL, Margulies KB, Smith AL, Tang WHW, Whellan DJ, Chen HH, Davila-Roman VG, McNulty S, Desvigne-Nickens P, Hernandez AF, Braunwald E, Redfield MM; National Heart, Lung, and Blood Institute Heart Failure Clinical Research Network. Effect of Inorganic Nitrite vs Placebo on Exercise Capacity Among Patients With Heart Failure With Preserved Ejection Fraction: The INDIE-HFpEF Randomized Clinical Trial. JAMA. 2018 Nov 6;320(17):1764-1773. doi: 10.1001/jama.2018.14852.
- Reddy YNV, Lewis GD, Shah SJ, LeWinter M, Semigran M, Davila-Roman VG, Anstrom K, Hernandez A, Braunwald E, Redfield MM, Borlaug BA. INDIE-HFpEF (Inorganic Nitrite Delivery to Improve Exercise Capacity in Heart Failure With Preserved Ejection Fraction): Rationale and Design. Circ Heart Fail. 2017 May;10(5):e003862. doi: 10.1161/CIRCHEARTFAILURE.117.003862.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Nitrite | Small molecule | 80 mg | Inhaled |