Phase 2
N=56
Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF)
Anemia
Bottom Line
View on ClinicalTrials.gov: NCT00286182 ↗Enrolled (actual)
56
Serious AEs
66.1%
Results posted
Jun 2016
Primary outcome: Primary: Change in Left Ventricular End-diastolic Volume — -6; -4 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erythropoietin alpha (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Mathew S. Maurer
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular End-diastolic Volume |
-6; -4 | — |
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
- Heart failure and a preserved ejection fraction (HFPEF) - EF >=40%
- Anemia - defined as hemoglobin = 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 Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT00286182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.