Table 2.
Studies evaluating anti-inflammatory therapies in heart failure.
| Study (year) | Design | No. of Patients | Setting | Type of intervention and comparator | Endpoints | Key results |
|---|---|---|---|---|---|---|
| Van Tassell et al. (2016) | Randomized, double-blinded, placebo-controlled pilot study | 30 | ADHF, EF < 40%, and CRP levels ≥ 5 mg/L | Anakinra 100 mg twice daily for 3 days followed by once daily for 11 days or matching placebo | Reduction of systemic inflammatory response comparing the AUC at 72 h for hsCRP between allocation groups | Significant reduction of systemic inflammatory response with IL-1 blockade |
| REDHART (2017) | Single-center, prospective, double-blinded, placebo-controlled study | 60 | Acute systolic HF (EF < 50%) with hsCRP >2 mg/L | Subcutaneous injections with anakinra 100 mg for 2 weeks, 12 weeks, or placebo | Improvement of peak aerobic exercise capacity (measurement of peak oxygen consumption and ventilatory efficiency) | No change in peak oxygen consumption at 2 weeks, improvement with continued anakinra for 12 weeks |
| Zhang et al. (2008) | Prospective, single-arm, non placebo-controlled, observational study | 35 | Decompensated congestive HF refractory to conventional therapy | Prednisone (1 mg/kg/ day with maximum dosage of 60 mg/day) added to the standard treatment | Daily urine volume, assessed dyspnea, global clinical status, changes in renal function. | Induction of potent diuresis, relief of congestive symptoms and improvements in clinical status and renal function |
| COPE-ADHF (2014) | Multicenter, non-blinded, randomized trial | 102 | ADHF | 1 dose of dexamethasone (20 mg/day) intravenously followed by prednisone (orally, daily, 1 mg/kg/day) for 7 days | CV death within 30 days; patient-assessed dyspnea, change from baseline in serum creatinine levels and physician-assessed global clinical status at day 7 | Significant creatinine reduction after 7 days of treatment, CV death reduction at 30 days, improvement in patient-assessed dyspnea and physician-assessed global clinical status |
| Parissis et al. (2004) | Randomized, placebo-controlled trial | 27 | Decompensated advanced HF | 10 min intravenous levosimendan bolus of 6 ug/kg followed by continuous infusion | Reduction of circulating pro-inflammatory cytokines and soluble apoptosis mediators in patients with decompensated severe HF | Significant reduction of circulating pro-inflammatory cytokine IL-6, TNF-alfa and soluble apoptosis mediators, such as soluble Fas and Fas ligand |
ADHF, acute decompensated heart failure; AUC, area under the curve; CV, cardiovascular; EF, ejection fraction; HF, heart failure; hsCRP, high sensitivity C reactive protein; HHF, hospitalization for heart failure.