Augmentation of Parasympathetic Signaling with Pyridostigmine in Heart Failure
Alternate Titles(s): APP-HF
- Description
This dataset was collected during a prospective phase 2 double-blind randomized placebo-controlled a dose-finding clinical trial to compare the effects of three ascending doses of pyridostigmine (15, 30, and 60 mg three times daily) vs. matching placebo on post-exercise heart rate recovery and other measures of sympathovagal balance. The study included four stages:
- Screening, randomization, and baseline assessment (visits 1-3)
- Study drug up-titration (visits 4-7)
- Study drug maintenance and primary endpoint assessment (Visits 8-9)
- Study drug down-titration (visits 10-12)
Subjects were eligible if they were ambulatory adults age 21-75 years with left ventricular ejection fraction less than 35% and NYHA Class II-III symptoms despite guideline-recommended medical and device therapy. Study drug was self-administered by the subject at approximately 8-hour intervals (morning dose at 6-8AM, afternoon dose at 2-4PM, and evening dose at 10-12PM). The deceleration in heart rate immediately after exercise was the primary outcome variable. Additional variables collected include oxygen uptake; resting heart rate; heart rate variability; cardiovagal baroreflex function; post-exercise heart rate recovery; and blood analysis.
- Geographic Coverage
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New York (State) - New York City
Access
- Restrictions
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Application RequiredAuthor Approval Required
- Instructions
- Please complete the Data Request Form to request access to this dataset. The information included in the form will be sent to the Corresponding Author who will evaluate your request for their data. The Corresponding Author may ask you to provide additional information if necessary.
- Grant Support
- Other Resources
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ClinicalTrials.gov
NCT01415921