We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

PIE II: Pharmacological Intervention in the Elderly II

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00123955
First Posted: July 26, 2005
Last Update Posted: March 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dalane W. Kitzman, Wake Forest School of Medicine
Results First Submitted: February 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diastolic Heart Failure
Heart Failure, Congestive
Interventions: Drug: Spironolactone
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Spironolactone

Spironolactone

Spironolactone: 25mg tablet daily for 9 months

Placebo

Placebo

Placebo: Placebo tablet daily for 9 months


Participant Flow:   Overall Study
    Spironolactone   Placebo
STARTED   42   38 
COMPLETED   37   34 
NOT COMPLETED   5   4 
Adverse Event                1                0 
Withdrawal by Subject                4                3 
Death                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Spironolactone

Spironolactone

Spironolactone: 25mg tablet daily for 9 months

Placebo

Placebo

Placebo: Placebo tablet daily for 9 months

Total Total of all reporting groups

Baseline Measures
   Spironolactone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   38   80 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.0  (7.3)   71.7  (7.3)   70.8  (7.3) 
Gender 
[Units: Participants]
     
Female   34   30   64 
Male   8   8   16 
Peak VO2 (ml/kg/min) 
[Units: Ml/kg/min]
Mean (Standard Deviation)
 13.5  (2.9)   13.3  (2.9)   13.4  (2.9) 
Workload (Watts) 
[Units: Watts]
Mean (Standard Deviation)
 63  (26)   60  (26)   62  (26) 


  Outcome Measures

1.  Primary:   Exercise Intolerance   [ Time Frame: Baseline, 4 and 9 months ]

2.  Primary:   Quality of Life   [ Time Frame: Baseline, 4 and 9 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Concentric Left Ventricular Remodeling   [ Time Frame: Baseline, 4 and 9 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Left Ventricular Diastolic Stiffness   [ Time Frame: Baseline, 4 and 9 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Dr. Dalane Kitzman
Organization: Wake Forest Baptist Health
phone: 336-716-3274
e-mail: dkitzman@wakehealth.edu


Publications:


Responsible Party: Dalane W. Kitzman, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00123955     History of Changes
Other Study ID Numbers: AG0030
R01AG018915 ( U.S. NIH Grant/Contract )
2R01AG018915-05 ( U.S. NIH Grant/Contract )
First Submitted: July 22, 2005
First Posted: July 26, 2005
Results First Submitted: February 6, 2015
Results First Posted: February 23, 2015
Last Update Posted: March 13, 2015