CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
KNO3 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02256345
NCT02256345Phase 2Completed
CompareCT.gov

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

University of Pennsylvania·interventional·Posted Oct 3, 2014·Updated Oct 3, 2017

In Brief

A Phase 2 clinical trial evaluating KNO3 and KCl for Heart Failure and Diastolic Heart Failure. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Diastolic Heart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 3, 2014
Enrollment StartJan 1, 2015
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.7 years ago

Interventions

KNO3drug

Active Comparator

KCldrug

Placebo Comparator