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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00358215




Registration number
NCT00358215
Ethics application status
Date submitted
27/07/2006
Date registered
31/07/2006
Date last updated
31/08/2018

Titles & IDs
Public title
RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
Scientific title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia
Secondary ID [1] 0 0
RED-HF™ Trial
Secondary ID [2] 0 0
20050222
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Anemia 0 0
Cardiovascular Disease 0 0
Ventricular Dysfunction 0 0
Congestive Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darbepoetin alfa
Treatment: Drugs - Placebo

Experimental: Darbepoetin alfa - Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.

Placebo Comparator: Placebo - Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.


Treatment: Drugs: Darbepoetin alfa
Administered by subcutaneous injection

Treatment: Drugs: Placebo
Placebo subcutaneous injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to All Cause Death or First Hospitalization for Worsening Heart Failure - Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
Timepoint [1] 0 0
From randomization to the end of study; maximum time on study was 73 months
Secondary outcome [1] 0 0
Time to Death From Any Cause - Time from randomization to death due to any cause, estimated by the Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
Timepoint [1] 0 0
From randomization to the end of study; maximum time on study was 73 months
Secondary outcome [2] 0 0
Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure - Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
Timepoint [2] 0 0
From randomization to the end of study; maximum time on study was 73 months
Secondary outcome [3] 0 0
Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score - The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.
Timepoint [3] 0 0
Baseline and Month 6
Secondary outcome [4] 0 0
Change From Baseline to Month 6 in KCCQ Symptom Frequency Score - The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.
Timepoint [4] 0 0
Baseline and Month 6

Eligibility
Key inclusion criteria
- Heart failure of at least 3 months duration and of New York Heart Association (NYHA)
class II, III, or IV

- hemoglobin between 9.0 g/dL and 12.0 g/dL

- left ventricular ejection fraction equal to or less than 40%
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Transferrin saturation (Tsat) < 15%

- Blood pressure > 160/100 mm Hg

- Heart failure primarily due to valvular heart disease or clinically significant
valvular heart disease that might lead to surgical correction within 12 months of
randomization

- Recipient of a major organ transplant or receiving renal replacement therapy

- Serum creatinine > 3.0 mg/dL (> 265 µmol/L)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Research Site - Camperdown
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2050 - Camperdown
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2139 - Concord
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5042 - Bedford Park
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3052 - Parkville
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin
alfa compared to placebo on the composite of time to death from any cause or first hospital
admission for worsening heart failure in patients with symptomatic left ventricular systolic
dysfunction and anemia.
Trial website
https://clinicaltrials.gov/show/NCT00358215
Trial related presentations / publications
McMurray JJ, Anand IS, Diaz R, Maggioni AP, O'Connor C, Pfeffer MA, Polu KR, Solomon SD, Sun Y, Swedberg K, Tendera M, van Veldhuisen DJ, Wasserman SM, Young JB; RED-HF Committees and Investigators. Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial. Eur J Heart Fail. 2009 Aug;11(8):795-801. doi: 10.1093/eurjhf/hfp098. Erratum in: Eur J Heart Fail. 2010 Jul;12(7):765. Pouler, A C [corrected to Pouleur, A C].
Swedberg K, Young JB, Anand IS, Cheng S, Desai AS, Diaz R, Maggioni AP, McMurray JJ, O'Connor C, Pfeffer MA, Solomon SD, Sun Y, Tendera M, van Veldhuisen DJ; RED-HF Committees; RED-HF Investigators. Treatment of anemia with darbepoetin alfa in systolic heart failure. N Engl J Med. 2013 Mar 28;368(13):1210-9. doi: 10.1056/NEJMoa1214865. Epub 2013 Mar 10.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications