Phase 2 N=33 Randomized Quadruple-blind Treatment

Safety Study of Pyridostigmine in Heart Failure

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT01415921 ↗

Enrolled (actual)

Serious AEs

15.2%

Results posted

Oct 2016

Primary outcome: Primary: Baseline Heart Rate Recovery — 32.5; 30.4 beats per minute

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pyridostigmine Bromide (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: NYU Langone Health
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline Heart Rate Recovery	32.5; 30.4	—
PRIMARY Post Exercise Heart Rate Recovery	38.5; 34.9	—

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.

Eligibility Criteria

Inclusion Criteria

Age 21-75 years
Symptomatic NYHA Class II-III heart failure >6 months
Left ventricular ejection fraction 3 months
Able and willing to provide written informed consent

Exclusion Criteria

Contraindications to cholinergic stimulation
Heart failure primarily attributable to genetic, valvular, infiltrative diseases
Persistent atrial fibrillation
Sick sinus syndrome
Pacemaker dependency during exercise
Severe chronotropic incompetence with peak exercise heart rate 160 mmHg
Resting heart rate 100 min-1
Serum sodium 2.5 mg/dl
Liver function tests >3 times upper limit of normal
Severe anemia (Hemoglobin 240 msec or second or third degree heart block on electrocardiogram
Exercise limited primarily by angina or non-cardiac co-morbid condition
Pregnant or breast-feeding women
Current treatment with medications known to interact with pyridostigmine
Known intolerance of oral preparations containing bromides
Any condition (e.g., psychiatric illness or active substance abuse) or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's ability to adhere with study procedures.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01415921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.