Trial record 2 of 2 for:    red-hf

RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00358215
First received: July 27, 2006
Last updated: July 14, 2014
Last verified: July 2014

July 27, 2006
July 14, 2014
June 2006
October 2012   (final data collection date for primary outcome measure)
Time to All Cause Death or First Hospitalization for Worsening Heart Failure [ Time Frame: From randomization to the end of study; maximum time on study was 73 months ] [ Designated as safety issue: No ]
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.
To determine the efficacy of darbepoetin alfa compared with placebo on the composite of time to death from any cause or first hospital admission for worsening HF in subjects with symptomatic left ventricular systolic dysfunction and anemia.
Complete list of historical versions of study NCT00358215 on ClinicalTrials.gov Archive Site
  • Time to Death From Any Cause [ Time Frame: From randomization to the end of study; maximum time on study was 73 months ] [ Designated as safety issue: Yes ]
    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.
  • Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure [ Time Frame: From randomization to the end of study; maximum time on study was 73 months ] [ Designated as safety issue: Yes ]
    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.
  • Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline to Month 6 in KCCQ Symptom Frequency Score [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.
  • "To evaluate the effects of treatment with darbepoetin alfa on:
  • time to death from any cause
  • time to cardiovascular death or first hospital admission for worsening HF, whichever occurs first
  • change from baseline to month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
  • change from baseline to month 6 in KCCQ Symptom Frequency Score
Not Provided
Not Provided
 
RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
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

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.

Several epidemiological studies have demonstrated an association between HF and anemia and correlation of increased risk for mortality and hospitalization with low hemoglobin in patients with HF. Earlier single-center interventional studies suggest that meaningful clinical benefits may be achieved by raising hemoglobin concentration in patients with symptomatic HF and anemia. Data from Amgen's completed phase 2 multi-center studies support this hypothesis and show that darbepoetin alfa is well tolerated in patients with symptomatic left ventricular systolic dysfunction and anemia and effectively raises hemoglobin. The pivotal phase 3 Study 20050222 RED-HF Trial is evaluating the effect of treatment with darbepoetin alfa on the composite risk of all-cause mortality or hospitalization for worsening HF in patients with symptomatic left ventricular systolic dysfunction and anemia. This study also evaluates the effect of darbepoetin alfa treatment on all-cause death, on cardiovascular death or hospitalization for worsening HF, and on patient-reported quality-of-life outcomes.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heart Failure
  • Anemia
  • Cardiovascular Disease
  • Ventricular Dysfunction
  • Congestive Heart Failure
  • Drug: Darbepoetin alfa
    Administered by subcutaneous injection
    Other Name: Aranesp®
  • Drug: Placebo
    Placebo subcutaneous injection
  • 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.
    Intervention: Drug: Darbepoetin alfa
  • 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.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2278
October 2012
October 2012   (final data collection date for primary outcome measure)

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%

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT00358215
20050222, RED-HF™ Trial
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP