pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
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acute heart failure | levosimendan | not classified | versus placebo or control No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
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REVIVE II, 2013 | levosimendan vs placebo | | | | REVIVE-I, 2003 | levosimendan vs placebo | | | | RUSSLAN, 2002 | levosimendan vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
REVIVE II, 2013 | Intravenous Levosimendan (n=299) vs. placebo (n=301) | patients with decompensated chronic heart failure | double blind Parallel groups Sample size: 299/301 Primary endpoint: worsening heart failure FU duration: 5 days | REVIVE-I, 2003 | levosimendan 0.1–0.2 mg/kg/min (n=-9) vs. placebo (n=-9) | patienst with HF andsymptoms at rest | Parallel groups Sample size: -9/-9 Primary endpoint: composite clinical FU duration: | RUSSLAN, 2002 | Levosimendan at different doses (0.1-0.4 microg x kg(-1) x min(-1)) for 6h (n=-9) vs. placebo (n=-9) | patients with left ventricular failure complicating acute myocardial infarction | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: hypotension or myocardial ischaemia FU duration: 14 days |
|
acute heart failure | levosimendan | not classified | versus active treatment No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
SURVIVE, 2007 | levosimendan vs dobutamine | | | all cause death (6M+) 0.91 [0.74; 1.12] Short term death (30d) 0.85 [0.63; 1.15] | CASINO | levosimendan vs dobutamine | | | | LIDO, 2002 | levosimendan vs dobutamine | | | |
Trial | Treatments | Patients | Method |
---|
SURVIVE, 2007 | Intravenous levosimendan (n=664) vs. intravenous dobutamine (n=663) | patients hospitalized with acute decompensated heart failure who required inotropic support | double-blind Parallel groups Sample size: 664/663 Primary endpoint: all cause mortality FU duration: 180 days | CASINO | Levosimendan 16 mg/kg þ 0.2 mg/kg/min (n=-9) vs. Dobutamine (10 mg/kg/min) and placebo (n=-9) | patients withdecompensatedlow-output HF | Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: | LIDO, 2002 | Levosimendan (n=-9) vs. Dobutamine (n=-9) | patients with low-output heart failure | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: haemodynamic improvement FU duration: 24h |
|
acute heart failure | nesiritide | not classified | versus placebo or control No demonstrated result for efficacy nesiritide inferior to placebo in terms of amelioration of Dyspnea at 24 h in ASCEND-HF, 2011 | 7 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
NSGET (efficacy trial), 2000 | nesiritide vs placebo | | | all cause death 1.48 [0.31; 7.03] | PROACTION, 2003 | nesiritide vs placebo | | | all cause death 4.88 [0.58; 41.10] | BNP-CARDS, 2007 | nesiritide vs placebo | | | | FUSION 2, 2008 | nesiritide vs placebo | | | | ASCEND-HF, 2011 | nesiritide vs placebo | | amelioration of Dyspnea at 24 h 1.11 [1.03; 1.19] | all cause death 0.90 [0.71; 1.14] 30-d HF rehospitalization
0.98 [0.82; 1.19] 30-d death or HF hospitalization 0.93 [0.81; 1.08] 30 day death 0.90 [0.71; 1.14] | VMAC (intravenous neseritide), 2002 | nesiritide vs placebo | | | | NSGET (comparative trial), 2000 | nesiritide vs control | | | |
Trial | Treatments | Patients | Method |
---|
NSGET (efficacy trial), 2000 | nesiritide(0.015 and 0.030 microg/kg/min (n=85) vs. placebo (n=42) | acutely decompensated heart failure requiring invasive monitoring | Sample size: 85/42 Primary endpoint: FU duration: | PROACTION, 2003 | nesiritidefor at least 12h (n=127) vs. placebo (n=123) | patients presenting to the ED with acutely decompensated
HF and dyspnea at rest or with minimal activity | double-blind Parallel groups Sample size: 127/123 Primary endpoint: FU duration: 30 days | BNP-CARDS, 2007 | nesiritide as a 0.01-µg/kg/min infusion for 48 hours (n=39) vs. placebo (n=36) | acute decompensated heart failure with moderate to severe renal insufficiency | Double blind Parallel groups Sample size: 39/36 Primary endpoint: >20% increase in SCr anytime during 1st hospital week FU duration: 7 days | FUSION 2, 2008 | nesiritide (2 µg/kg bolus plus 0.01 µg/kg-per-minute infusion for four to six hours) (n=911) vs. placebo (n=0) | patients with ACC/AHA stage C/D heart failure with two recent heart-failure hospitalizations, an ejection fraction of less than 40%, and NYHA class 4 symptoms or NYHA class 3 symptoms with creatinine clearance less than 60 mL/min | double-blind Parallel groups Sample size: 911/0 Primary endpoint: mortality and CV or renal hospitalization FU duration: 12 weeks | ASCEND-HF, 2011 | intravenous nesiritide for 24 hours to 7 days on top of standard therapy (n=3496) vs. matching placebo (n=3511) | Patients hospitalized for heart
failure (within 24 hours of hospitalization and institution of acute IV therapy for ADHF) | double-blind Parallel groups Sample size: 3496/3511 Primary endpoint: coprimary: dyspnea, death or HF hospitalization FU duration: 30 days | VMAC (intravenous neseritide), 2002 | intravenous nesiritidefor 3 hours (n=204) vs. placebo (n=142) 3rd arms with IV nitroglycerin for 3 hours(n=143) | acutely decompensated heart failure requiring hospitalization
| double-blind Sample size: 204/142 Primary endpoint: FU duration:
| NSGET (comparative trial), 2000 | nesiritide(0.015 and 0.030 microg/kg/min (n=203) vs. usual care (n=102)
| acutely decompensated heart failure requiring invasive monitoring
| open Parallel groups Sample size: 203/102 Primary endpoint: FU duration: <5 days
|
|
acute heart failure | nesiritide | not classified | versus active treatment No demonstrated result for efficacy | 3 trials | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
VMAC (24h), 2002 | nesiritide vs nitroglycerin | | | all cause death 1.56 [0.80; 3.04] | FUSION 1, 2004 | nesiritide vs standard care | | | | PRECEDENT, 2002 | nesiritide vs dobutamine | | | |
Trial | Treatments | Patients | Method |
---|
VMAC (24h), 2002 | nesiritideinfusion for 24 hours (n=280) vs. nitroglycerin (n=218) | acutely decompensated heart failure requiring hospitalization | Sample size: 280/218 Primary endpoint: FU duration: | FUSION 1, 2004 | nesiritide 0.005 microg/kg/min or 0.010 microg/kg/min once weekly (n=-9) vs. standard care (n=-9) | outpatient with co-morbid advanced heart failure and renal insufficiency | open Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: 12 weeks | PRECEDENT, 2002 | nesiritide(0.015 or 0.03 microg/kg/min) (n=-9) vs. Dobutamine (> or =5 microg/kg/min) (n=-9) | Symptomatic, Decompensated CHF | open Parallel groups Sample size: -9/-9 Primary endpoint: ECG Holter FU duration: |
|
acute heart failure | rolofylline | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
PROTECT, 2010 | rolofylline vs placebo | | | treatment success 0.92 [0.78; 1.09] |
Trial | Treatments | Patients | Method |
---|
PROTECT, 2010 | daily intravenous rolofylline (30 mg) for up to 3 days (n=-9) vs. placebo (n=-9) | patients hospitalized for acute heart failure with impaired renal function | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: treatment success FU duration: 3 days (60 days) |
|
acute heart failure | serelaxin | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
RELAX-AHF, 2013 | serelaxin vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
RELAX-AHF, 2013 | 48-h intravenous infusions of placebo or serelaxin (30 ìg/kg per day) within 16 h from presentation (n=-9) vs. placebo (on top stnadard care) (n=-9) | patients admitted to hospital for acute heart failure | Sample size: -9/-9 Primary endpoint: FU duration: |
|
acute heart failure | serelaxin | not classified | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | Trial | control | p<0.05 | harm | NS |
---|
Pre-RELAX-AHF, 2009 | serelaxin vs placebo | | | |
Trial | Treatments | Patients | Method |
---|
Pre-RELAX-AHF, 2009 | intravenous relaxin for 48 hours: 10µg/kg daily, 30µg/kg daily, 100µg/kg daily, 250µg/kg daily (n=172) vs. placebo (n=62) | Patients hospitalized with acute heart failure | double blind Parallel groups Sample size: 172/62 Primary endpoint: none defined FU duration: dose-finding phase IIb study |
|