Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF)

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mathew S. Maurer
• Collaborator: National Institute on Aging (NIA)
• Treatments: Epoetin Alfa

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