Efficacy of Treating Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF) on Ventricular Function, Exercise Capacity and Health Status
Overview
- Phase
- Phase 2
- Intervention
- Erythropoietin alpha
- Conditions
- Anemia
- Sponsor
- Mathew S. Maurer
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Change in Left Ventricular End-diastolic Volume
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Mathew S. Maurer
Associate Professor of Clinical Medicine
Columbia University
Eligibility Criteria
Inclusion Criteria
- •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.
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 \< 60% predicted)
- •Renal failure (GFR \< 15 ml/min)
- •Hemoglobin \< 8 g/dL
- •Exercise limited by angina, claudication, orthopedic, or neurological diseases.
Arms & Interventions
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.
Intervention: Erythropoietin alpha
Placebo
Placebo consists of saline injections.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Left Ventricular End-diastolic Volume
Time Frame: Baseline and 6 month
This outcome measure is collected using a three dimensional echocardiography.