Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF)
Completed · Phase 2 · Has a placebo group
Conditions studied: Anemia
In brief
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 ventricular remodeling, significant improvements in exercise capacity, and improved health status, as compared with placebo.
Key facts
- Study ID
- NCT00286182
- Run by
- Mathew S. Maurer
- People needed
- 56
- Starts
- 2007-07-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2017-03-10
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Clinical Cardiovascular Research Laboratory for the Elderly — New York, New York, United States
Full record on ClinicalTrials.gov
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