CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Pyridostigmine Bromidedrug
Likely dose
Pyridostigmine Bromide 60 mgfrom 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/NCT01415921
NCT01415921Phase 2Completed
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Augmentation of Parasympathetic Signaling With Pyridostigmine in Heart Failure

NYU Langone Health·interventional·Posted Aug 12, 2011·Updated Jul 31, 2017

In Brief

A Phase 2 clinical trial evaluating Pyridostigmine Bromide for Heart Failure. Completed, enrolled 33 participants across 1 site.

Detailed Summary

Heart failure, a common heart disease affecting nearly 6 million Americans, is associated with high rates of hospitalization and death. Abnormalities in the autonomic nervous system are thought to play an important role in the progression of heart failure. This proposal aims to determine whether novel application of pyridostigmine, a drug currently approved by the FDA only for the treatment of neuromuscular disease, can improve autonomic nervous system function in heart failure patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
CollaboratorsNathan Kline Institute for Psychiatric Research, Oklahoma State University, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 12, 2011
Enrollment StartOct 1, 2011
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.9 years ago

Interventions

Pyridostigmine Bromidedrug

15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue.