Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF)
|ClinicalTrials.gov Identifier: NCT00286182|
Recruitment Status : Completed
First Posted : February 3, 2006
Results First Posted : June 10, 2016
Last Update Posted : March 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: Erythropoietin alpha Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Efficacy of Treating Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF) on Ventricular Function, Exercise Capacity and Health Status|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: 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.
Drug: 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 any given weekly interval.
Other Name: Erythropoietin alpha (Epogen)
Placebo Comparator: Placebo
Placebo consists of saline injections.
- Change in Left Ventricular End-diastolic Volume [ Time Frame: Baseline and 6 month ]This outcome measure is collected using a three dimensional echocardiography.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286182
|United States, New York|
|Clinical Cardiovascular Research Laboratory for the Elderly|
|New York, New York, United States, 10034|
|Principal Investigator:||Mathew S Maurer, MD||Columbia University|