drugset / Trial / NCT01932606

Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction

NCT01932606 ↗

Phase 2 Completed 28 enrolled Barry Borlaug
RandomizedParallel-groupDouble-blindTreatment

Summary

Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study assessed the effects of acute nitrite administration on resting and exercise hemodynamics in patients with HFpEF.

Timeline

Start
2013-08
Primary completion
2014-10
Completion
2014-10

Outcome

Met primary endpoint

paper primary endpoint of exercise PCWP was substantially improved by nitrite compared with placebo (adjusted mean: 19 ± 5 mm Hg vs. 28 ± 6 mm PMID 26449137 ↗

registry p = 0.0003 NCT01932606 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Nitrite Small molecule 50 ug/kg Intravenous