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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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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 underlying clinical pathologies and co-morbid conditions present in these patients, a common pathophysiologic explanation is generally applied to explain their clinical symptoms. Our preliminary data show that a significant subgroup with HFPEF has increases in ventricular volumes and expanded plasma volumes, consistent with a volume overloaded state. In the setting of a preserved EF with end diastolic volume increased, stroke volume must increase, indicating a high output state. Anemia may be an important, modifiable contributor to the observed high output and volume overload as well as exercise intolerance in elderly HFPEF patients, abnormal ventricular remodeling and impaired overall health status and quality of life. This protocol evaluates the impact of treating anemia in subjects with HFPEF. The specific aims of the current study are to provide a comprehensive and mechanistically based assessment of how correcting anemia in subjects with HFPEF can impact on functional capacity, ventricular structure and function and overall health status. We propose to perform a randomized, prospective, double blind study in 80 subjects with HFPEF to test the hypothesis that the administration of subcutaneous erythropoietin will be associated with reverse ventricular remodeling, significant improvements in exercise capacity and improved health status.

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Erythropoietin alpha

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.

Group Type EXPERIMENTAL

Erythropoietin alpha

Intervention Type DRUG

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

Placebo consists of saline injections.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Erythropoietin alpha

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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Erythropoietin alpha (Epogen)

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No