Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF)
Condition: Anemia
MeSH terms: Heart Failure; Anemia
Intervention: Erythropoietin alpha; Placebo
Intervention description: 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.; Placebo
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Heart Failure; Elderly; Diastolic Dysfunction; Anemia; Ventricular End Diastolic Volume; Aged

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 ventricular remodeling, significant improvements in exercise capacity, and
      improved health status, as compared with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Heart failure and a preserved ejection fraction (HFPEF) - EF >=40%

          2. Anemia - defined as hemoglobin < 12 g/dL

          3. Age >= 55 years

          4. 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:

          1. Presence of uncontrolled hypertension (Systolic blood pressure > 160 mm Hg and/or
             diastolic blood pressure > 90 mm Hg)

          2. Resting heart rate > 120 bpm

          3. Baseline 6-minute walk test > 450 meters

          4. Valvular heart disease (e.g. more than mild regurgitant or stenotic mitral, aortic,
             tricuspid, or pulmonic valve disease).

          5. Infiltrative cardiac disease such as hemochromatosis and amyloidosis

          6. Hypertrophic cardiomyopathy

          7. Chronic pulmonary disease (FEV 1 < 60% predicted)

          8. Renal failure (GFR < 15 ml/min)

          9. Hemoglobin < 8 g/dL

         10. BMI > 40

         11. Exercise limited by angina, claudication, orthopedic, or neurological diseases.

         12. Severe liver dysfunction that is defined by an international normalized ratio > 2.0,
             not caused by an anticoagulant.

         13. Current or recent treatment (within past 6 months) with erythropoietin

         14. Erythropoietin level > 100 mU/ml

         15. Recent cardiac surgery (< 3 months)

         16. Known iron deficiency anemia from chronic GI blood loss, uterine bleeding, or other
             chronic bleeding

         17. Planned surgery during the course of the study

         18. Significant alcohol use or illicit drug use.

         19. Patients with a known hypercoagulable state.

         20. Active hematologic disease (e.g. sickle cell anemia, thalassemia, chronic myelogenous
             leukemia) or malignancy

         21. Patients with current seizure disorder or activity

         22. Patients who are known to be pregnant

         23. History of deep venous thrombosis (DVT) or pulmonary embolus (PE) within 12 months
             before study entry. Prior superficial thrombophlebitis is not an exclusion criterion.

         24. History of cerebrovascular accident (CVA) within 6 months

         25. History of transient ischemic attack (TIA) within 6 months

         26. 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).

         27. Allergy or sensitivity to human serum albumin

         28. Known hypersensitivity to mammalian cell-derived products