Status:
COMPLETED
Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF)
Lead Sponsor:
Mathew S. Maurer
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Anemia
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if treating anemia with subcutaneous erythropoetin in patients with heart failure and a preserved ejection fraction (HFPEF) will be associated with reverse ve...
Detailed Description
Heart failure frequently occurs in patients with a preserved ejection fraction (HFPEF) and affected subjects are predominantly elderly women with several co-morbid conditions. Despite the diversity of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00286182
Start Date
July 1 2007
End Date
November 1 2012
Last Update
March 10 2017
Active Locations (1)
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1
Clinical Cardiovascular Research Laboratory for the Elderly
New York, New York, United States, 10034