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Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Mathew S. Maurer, Columbia University
ClinicalTrials.gov Identifier:
NCT00286182
First received: February 1, 2006
Last updated: May 3, 2016
Last verified: May 2016
Results First Received: August 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Anemia
Interventions: Drug: Erythropoietin alpha
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
Erythropoietin Alpha

Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.

Erythropoietin alpha: Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in

Placebo

Placebo consists of saline injections.

Placebo: Placebo


Participant Flow:   Overall Study
    Erythropoietin Alpha     Placebo  
STARTED     28     28  
COMPLETED     23     25  
NOT COMPLETED     5     3  



  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
Erythropoietin Alpha Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
Placebo

Placebo consists of saline injections.

Placebo: Placebo

Total Total of all reporting groups

Baseline Measures
    Erythropoietin Alpha     Placebo     Total  
Number of Participants  
[units: participants]
  28     28     56  
Age  
[units: years]
Mean (Standard Deviation)
  79  (11)     74  (9)     76.5  (10)  
Gender  
[units: participants]
     
Female     18     20     38  
Male     10     8     18  
Region of Enrollment  
[units: participants]
     
United States     28     28     56  



  Outcome Measures

1.  Primary:   Change in Left Ventricular End-diastolic Volume   [ Time Frame: Baseline and 6 month ]


  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
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  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: Mathew Maurer, MD, Professor of Medicine at the Columbia University Medical Center
Organization: Columbia University
phone: 212-305-9808
e-mail: msm10@cumc.columbia.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mathew S. Maurer, Columbia University
ClinicalTrials.gov Identifier: NCT00286182     History of Changes
Other Study ID Numbers: AAAB3037
R01AG027518-01 ( US NIH Grant/Contract Award Number )
Study First Received: February 1, 2006
Results First Received: August 17, 2015
Last Updated: May 3, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board