Trial · NCT00358215
RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
NCT00358215, Phase 3, Completed, Amgen; results first posted 2013-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial. Trials, record NCT00358215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00358215
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
- NCT number
- NCT00358215
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,278 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Heart Failure, Anemia, Cardiovascular Disease, Ventricular Dysfunction, Congestive Heart Failure
- Interventions
- Darbepoetin alfa, Placebo
- First posted
- 2006-07-31
- Last updated
- 2022-11-08
- Results first posted
- 2013-12-13
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to All Cause Death or First Hospitalization for Worsening Heart Failure | From randomization to the end of study; maximum time on study was 73 months | 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. |
| Secondary | Time to Death From Any Cause | From randomization to the end of study; maximum time on study was 73 months | 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. |
| Secondary | Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure | From randomization to the end of study; maximum time on study was 73 months | 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. |
| Secondary | Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Baseline and Month 6 | 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. |
| Secondary | Change From Baseline to Month 6 in KCCQ Symptom Frequency Score | Baseline and Month 6 | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to All Cause Death or First Hospitalization for Worsening Heart Failure | From randomization to the end of study; maximum time on study was 73 months | Intent-to-treat (ITT) analysis set, defined as all randomized participants | days | MEDIAN |
| SECONDARY | Time to Death From Any Cause | From randomization to the end of study; maximum time on study was 73 months | Intent-to-treat | days | MEDIAN |
| SECONDARY | Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure | From randomization to the end of study; maximum time on study was 73 months | Intent-to-treat | days | MEDIAN |
| SECONDARY | Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Baseline and Month 6 | Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Month 6 in KCCQ Symptom Frequency Score | Baseline and Month 6 | Intent-to-treat participants with non-missing change from Baseline to Month 6 in KCCQ score. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to All Cause Death or First Hospitalization for Worsening Heart Failure | Placebo | 1260.0 | Inter-Quartile Range 387.0 to 2176.0 | days | |
| Time to All Cause Death or First Hospitalization for Worsening Heart Failure | Darbepoetin Alfa | 1184.0 | Inter-Quartile Range 445.0 to 2074.0 | days | |
| Time to Death From Any Cause | Placebo | 1637.0 | Inter-Quartile Range 766.0 to 2229.0 | days | |
| Time to Death From Any Cause | Darbepoetin Alfa | 1629.0 | Inter-Quartile Range 682.0 to 2117.0 | days | |
| Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure | Placebo | 1414.0 | Inter-Quartile Range 429.0 to NA | days | |
| Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure | Darbepoetin Alfa | 1395.0 | Inter-Quartile Range 483.0 to NA | days | |
| Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Placebo | 4.48 | Standard Error 0.68 | units on a scale | |
| Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Darbepoetin Alfa | 6.68 | Standard Error 0.68 | units on a scale | |
| Change From Baseline to Month 6 in KCCQ Symptom Frequency Score | Placebo | 3.91 | Standard Error 0.76 | units on a scale | |
| Change From Baseline to Month 6 in KCCQ Symptom Frequency Score | Darbepoetin Alfa | 6.20 | Standard Error 0.76 | units on a scale |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 1,142 | |
| Overall Study | STARTED | Darbepoetin Alfa | 1,136 | |
| Overall Study | Received Investigational Product | Placebo | 1,140 | |
| Overall Study | Received Investigational Product | Darbepoetin Alfa | 1,133 | |
| Overall Study | COMPLETED | Placebo | 463 | |
| Overall Study | COMPLETED | Darbepoetin Alfa | 484 | |
| Overall Study | NOT COMPLETED | Placebo | 679 | |
| Overall Study | NOT COMPLETED | Darbepoetin Alfa | 652 |
Source ClinicalTrials.gov
Adverse events1,574
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Angina pectoris | Cardiac disorders | Placebo | 60 | 1,140 | |
| other | Angina pectoris | Cardiac disorders | Darbepoetin Alfa | 52 | 1,133 | |
| other | Cardiac failure | Cardiac disorders | Placebo | 92 | 1,140 | |
| other | Cardiac failure | Cardiac disorders | Darbepoetin Alfa | 69 | 1,133 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 68 | 1,140 | |
| other | Constipation | Gastrointestinal disorders | Darbepoetin Alfa | 81 | 1,133 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 135 | 1,140 | |
| other | Diarrhoea | Gastrointestinal disorders | Darbepoetin Alfa | 148 | 1,133 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 75 | 1,140 | |
| other | Nausea | Gastrointestinal disorders | Darbepoetin Alfa | 71 | 1,133 |
1 to 10 of 1,574Source ClinicalTrials.gov
See all 1,574 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Darbepoetin Alfa | ||
| Total, other adverse events | Placebo | 741 | 1,140 |
| Total, other adverse events | Darbepoetin Alfa | 710 | 1,133 |
| Total, serious adverse events | Placebo | 741 | 1,140 |
| Total, serious adverse events | Darbepoetin Alfa | 781 | 1,133 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Darbepoetin Alfa vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00358215
GET https://conductscience.org/api/trials/v1/NCT00358215/events?page=2