Status:
COMPLETED
Safety Study of Pyridostigmine in Heart Failure
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Nathan Kline Institute for Psychiatric Research
Oklahoma State University
Conditions:
Heart Failure
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
Brief 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 pla...
Detailed Description
Autonomic dysregulation of the cardiovascular system, characterized by heightened sympathetic activity and withdrawal of parasympathetic activity promotes progression of heart failure. Pharmacological...
Eligibility Criteria
Inclusion
- Age 21-75 years
- Symptomatic NYHA Class II-III heart failure \>6 months
- Left ventricular ejection fraction \<35%
- Previous implantation of implantable cardiovertor defibrillator or pacemaker
- Guideline-recommended heart failure treatment for \> 3 months
- Able and willing to provide written informed consent
Exclusion
- 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 \< 100 min-1
- Severe exercise intolerance (unable to complete first stage of Bruce Protocol)
- Coronary or cerebral atherothrombotic events within the past year
- Hospitalization of emergency room visit for heart failure within last 3 months
- ICD shock in last 6 months
- Diabetes mellitus with peripheral neuropathy
- Autonomic or peripheral neuropathy of any cause
- Systolic blood pressure \<90 or \>160 mmHg
- Resting heart rate \<60 or \>100 min-1
- Serum sodium \< 132 mmol/L
- Serum creatinine \>2.5 mg/dl
- Liver function tests \>3 times upper limit of normal
- Severe anemia (Hemoglobin \<10 gm/dl)
- FEV1.0 \< 60% of predicted or FEV1.0/FVC ratio \<70%
- PR interval \>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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01415921
Start Date
October 1 2011
End Date
July 1 2015
Last Update
July 31 2017
Active Locations (1)
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1
New York University Langone Medical Center
New York, New York, United States, 10016