drugset / Trial / NCT02256345

Pharmacokinetics, Pharmacodynamics, and Impact of Inorganic Nitrate on Exercise in HFpEF

NCT02256345

Phase 2 Completed 12 enrolled University of Pennsylvania
RandomizedParallel-groupSingle-blindTreatment

Summary

This study will be performed to determine the safety, tolerability, and dose-response to inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study: 1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely given to subjects with HFpEF. 2. Determine if there is a dose-response effect of nitrate supplementation on exercise capacity, evidenced by peak oxygen consumption (peak VO2), and physiologic adaptations to exercise.

Timeline

Start
2015-01
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Potassium Nitrate Other / unclassified 6 mmol Oral