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PIE II: Pharmacological Intervention in the Elderly II

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dalane W. Kitzman, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00123955
First received: July 22, 2005
Last updated: February 23, 2015
Last verified: February 2015
Results First Received: February 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diastolic Heart Failure
Heart Failure, Congestive
Interventions: Drug: Spironolactone
Drug: Placebo

  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
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
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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
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  
Number of Participants  
[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.   Safety Issue:   No

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

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


  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
No text entered.


  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: 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 ( US NIH Grant/Contract Award Number )
2R01AG018915-05 ( US NIH Grant/Contract Award Number )
Study First Received: July 22, 2005
Results First Received: February 6, 2015
Last Updated: February 23, 2015
Health Authority: United States: Federal Government