Trial Outcomes & Findings for Anemia in Heart Failure With a Preserved Ejection Fraction (HFPEF) (NCT NCT00286182)

Results Overview

This outcome measure is collected using a three dimensional echocardiography.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

Baseline and 6 month

Results posted on

2017-03-10

Participant milestones
Measure	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. 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	Placebo Placebo consists of saline injections. Placebo: Placebo
Overall Study STARTED	28	28
Overall Study COMPLETED	23	25
Overall Study NOT COMPLETED	5	3

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Erythropoietin Alpha n=28 Participants 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.	Placebo n=28 Participants Placebo consists of saline injections. Placebo: Placebo	Total n=56 Participants Total of all reporting groups
Age, Continuous	79 years STANDARD_DEVIATION 11 • n=5 Participants	74 years STANDARD_DEVIATION 9 • n=7 Participants	76.5 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants

Timeframe: Baseline and 6 month

This outcome measure is collected using a three dimensional echocardiography.

Outcome measures
Measure	Erythropoietin Alpha n=23 Participants 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. 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	Placebo n=25 Participants Placebo consists of saline injections. Placebo: Placebo
Change in Left Ventricular End-diastolic Volume	-6 mL Standard Error 14	-4 mL Standard Error 16

Serious events: 19 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Erythropoietin Alpha n=28 participants at risk 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.	Placebo n=28 participants at risk Placebo consists of saline injections. Placebo: Placebo
General disorders Hospitalization	57.1% 16/28 • Number of events 16	50.0% 14/28 • Number of events 14
General disorders Sudden Death	0.00% 0/28	3.6% 1/28 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.00% 0/28	3.6% 1/28 • Number of events 1
Cardiac disorders Heart Failure	10.7% 3/28 • Number of events 3	7.1% 2/28 • Number of events 2

Adverse event data not reported

Columbia University

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