CHANCE-HF
Trial question
What is the role of CA-125-guided therapy in patients with acute HF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 380
380 patients (168 female, 212 male).
Inclusion criteria: patients discharged for acute HF and high CA-125.
Key exclusion criteria: life expectancy < 12 months due to other diseases different from HF; pregnancy; angina pectoris higher than class II; valvular heart disease already scheduled for surgical intervention.
Interventions
N=187 CA-125-guided therapy (treatment measures aimed to keep CA-125 ≤ 35 U/mL).
N=193 standard of care (therapy based on established European current guidelines).
Primary outcome
Death or acute heart failure readmission at 1 year, restricted mean survival time
0.74 years
0.66 years
0.7 years
0.6 years
0.4 years
0.2 years
0.0 years
Carbohydrate antigen-125-guided
therapy
Standard of
care
Significant
increase ▲
Significant increase in death or acute HF readmission at 1 year, restricted mean survival time (0.74 years vs. 0.66 years; AD 0.08 years, 95% CI 0.02 to 0.15).
Secondary outcomes
No significant difference in death or any rehospitalization at 1 year, restricted mean survival time (0.67 years vs. 0.61 years; AD 0.054 years, 95% CI -0.02 to 0.13).
No significant difference in the rate of all-cause mortality and days alive and out of the hospital (16.6% vs. 18.1%; HR 0.92, 95% CI 0.57 to 1.49).
Significant decrease in the incidence of recurrent hospitalizations (0.67 events/person-year vs. 1.06 events/person-year; RR 0.63, 95% CI 0.5 to 0.8).
Safety outcomes
No significant differences in hospitalizations due to hyperkalemia, hypokalemia or acute renal failure.
Conclusion
In patients discharged for acute HF and high CA-125, CA-125-guided therapy was superior to standard of care with respect to death or acute HF readmission at 1 year, restricted mean survival time.
Reference
Julio Núñez, Pau Llàcer, Vicente Bertomeu-González et al. Carbohydrate Antigen-125-Guided Therapy in Acute Heart Failure: CHANCE-HF: A Randomized Study. JACC Heart Fail. 2016 Nov;4(11):833-843.
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