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Safety Study of Pyridostigmine in Heart Failure (APP-HF)

This study has been completed.
Sponsor:
Collaborators:
Nathan Kline Institute for Psychiatric Research
Oklahoma State University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01415921
First received: August 10, 2011
Last updated: August 31, 2016
Last verified: August 2016
Results First Received: May 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Heart Failure
Intervention: Drug: Pyridostigmine Bromide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Admissions logs and other existing electronic hospital information systems

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pyridostigmine Bromide

Forced titration protocol 15-60 mg every 8 hours as tolerated

Pyridostigmine Bromide: 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.

Placebo

Matching placebo forced titration 15-60 mg as tolerated

Pyridostigmine Bromide: 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.


Participant Flow:   Overall Study
    Pyridostigmine Bromide   Placebo
STARTED   16   17 
COMPLETED   13   14 
NOT COMPLETED   3   3 
Adverse Event                0                1 
Physician Decision                1                1 
Withdrawal by Subject                0                1 
Other                2                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pyridostigmine Bromide

Forced titration protocol 15-60 mg every 8 hours as tolerated

Pyridostigmine Bromide: 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.

Placebo

Matching placebo forced titration 15-60 mg as tolerated

Pyridostigmine Bromide: 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.

Total Total of all reporting groups

Baseline Measures
   Pyridostigmine Bromide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   17   33 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   14   15   29 
>=65 years   2   2   4 
Gender 
[Units: Participants]
     
Female   2   2   4 
Male   14   15   29 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   3   2   5 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   3   6   9 
White   2   0   2 
More than one race   8   9   17 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   16   17   33 


  Outcome Measures
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1.  Primary:   Baseline Heart Rate   [ Time Frame: Baseline ]

2.  Primary:   Post Exercise Heart Rate Recovery   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stuart Katz, MD
Organization: New York University School of Medicine
phone: 212-263-3946
e-mail: stuart.katz@nyumc.org


Publications:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01415921     History of Changes
Other Study ID Numbers: 10-02167
10-02167 ( Other Identifier: NYU IRB )
1R01HL103988 ( US NIH Grant/Contract Award Number )
Study First Received: August 10, 2011
Results First Received: May 20, 2016
Last Updated: August 31, 2016