Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF)
Anemia
About this trial
This is an interventional treatment trial for Anemia focused on measuring Heart Failure, Elderly, Diastolic Dysfunction, Anemia, Ventricular End Diastolic Volume, Aged
Eligibility Criteria
Inclusion Criteria: Heart failure and a preserved ejection fraction (HFPEF) - EF >=40% Anemia - defined as hemoglobin < 12 g/dL Age >= 55 years Patients must be able to understand and sign the informed consent document after the nature of the study has been fully explained, prior to beginning any study procedures. Exclusion Criteria: Presence of uncontrolled hypertension (Systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 90 mm Hg) Resting heart rate > 120 bpm Baseline 6-minute walk test > 450 meters Valvular heart disease (e.g. more than mild regurgitant or stenotic mitral, aortic, tricuspid, or pulmonic valve disease). Infiltrative cardiac disease such as hemochromatosis and amyloidosis Hypertrophic cardiomyopathy Chronic pulmonary disease (FEV 1 < 60% predicted) Renal failure (GFR < 15 ml/min) Hemoglobin < 8 g/dL BMI > 40 Exercise limited by angina, claudication, orthopedic, or neurological diseases. Severe liver dysfunction that is defined by an international normalized ratio > 2.0, not caused by an anticoagulant. Current or recent treatment (within past 6 months) with erythropoietin Erythropoietin level > 100 mU/ml Recent cardiac surgery (< 3 months) Known iron deficiency anemia from chronic GI blood loss, uterine bleeding, or other chronic bleeding Planned surgery during the course of the study Significant alcohol use or illicit drug use. Patients with a known hypercoagulable state. Active hematologic disease (e.g. sickle cell anemia, thalassemia, chronic myelogenous leukemia) or malignancy Patients with current seizure disorder or activity Patients who are known to be pregnant History of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 12 months before study entry. Prior superficial thrombophlebitis is not an exclusion criterion. History of cerebrovascular accident (CVA) within 6 months History of transient ischemic attack (TIA) within 6 months History of acute coronary syndrome (ACS), or other arterial thrombosis within 6 months before study entry. ACS includes unstable angina, Q wave myocardial infarction (QwMI), and non-Q wave myocardial infarction (NQMI). Allergy or sensitivity to human serum albumin Known hypersensitivity to mammalian cell-derived products
Sites / Locations
- Clinical Cardiovascular Research Laboratory for the Elderly
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Erythropoietin alpha
Placebo
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 consists of saline injections.