"Comparison of Ultrafiltration and Pharmacologic Therapy in Acute Decompensated Heart Failure". The New England Journal of Medicine. ClinicalTrials.gov number, NCT00608491.
Links to original sources: Wiki Journal Post Full Journal Article
In patients with acute decompensated heart failure, worsened renal function, and persistent congestion, is ultrafiltration superior to stepped pharmacologic therapy with regards to renal function preservation and weight loss?
In patients with acute decompensated heart failure, worsened renal function, and persistent congestion, stepped pharmacologic therapy was superior to ultrafiltration for the preservation of renal function at 96 hours, with similar weight loss. Ultrafiltration was associated with a higher rate of adverse events.
The CARRESS-HF (Cardiorenal Rescue Study in Acute Decompensated Heart Failure) trial examined the effects of ultrafiltration compared to diuretic-based pharmacologic therapy in patients hospitalized for acute decompensated heart failure with persistent congestion and worsening renal function. Ultrafiltration resulted in a significant increase in serum creatinine levels at 96 hours, did not lead to superior weight loss, and was associated with a higher rate of adverse events.
Current treatment guidelines state that ultrafiltration is reasonable in patients with congestive symptoms not responding to medical therapy. However, little was known about its safety and efficacy compared to pharmacologic therapy in patients with acute decompensated heart failure complicated by cardiorenal syndrome.
- Multicenter, randomized trial - N=188 patients - Stepped pharmacologic therapy (n=94) vs. ultrafiltration (n=94) - Primary endpoint: Bivariate change in serum creatinine level and body weight at 96 hours - Follow-up: 60 days
- Inclusion criteria: Hospitalized for acute decompensated heart failure, worsened renal function (increase in serum creatinine by at least 0.3 mg/dL within 12 weeks prior or 10 days after hospital admission), and persistent congestion. - Exclusion criteria: Serum creatinine level >3.5 mg/dL, intravenous vasodilators or inotropic agents use at admission. - Baseline characteristics: Median age 68 years, 75% male, median ejection fraction 33%, 77% had been hospitalized for heart failure in the previous year.
- Pharmacologic therapy: Intravenous diuretics managed to maintain urine output of 3 to 5 liters per day. - Ultrafiltration: Performed at 200 ml/h fluid removal rate.
- Primary: The bivariate end point of the change in serum creatinine level and weight 96 hours after enrollment showed a significant difference (P=0.003) favoring pharmacologic therapy. - Secondary: No significant differences in weight loss, mortality, or rate of hospitalization for heart failure during follow-up.
- The study was not blinded which could introduce bias. - The safest and most effective rates and durations of ultrafiltration are unknown. Outcomes may differ with variations in ultrafiltration intensity. - Results may not apply to other populations with acute decompensated heart failure.
Supported by the National Heart, Lung, and Blood Institute.
The full text of the CARRESS-HF trial is available at NEJM.org.