Supplemental Table 1. List of Advanced Heart Failure Trials Included in Analysis
StudyNInterventionStudies with ≤10 participants
Omoto et al. 16LVAD as bridge to transplantation
Kassai et al. 28Transapical left ventricular lead placement in CRT
Schwartz et al. 38Vagal stimulation
Jaski et al. 49Enzyme replacement via gene transplantation
Esmore et al. 59LVAD as bridge to transplantation vs. destination therapy
Dean et al. 69Moderate-intensity resistance training
Torre-Amione et al. 79Upper thoracic spinal cord stimulation
Benetti et al. 810Direct myocardial implantation of human fetal stem cells
De Ferrari et al. 910Intravenous administration of ivabradine
Studies with 11-100 participants
Grossman et al. 1011Low-dose levodopa (L-DOPA)
Carraro et al. 1112Daily periods of rest in dynamic cardiomyoplasty patients
Gold et al. 1212Dual-chamber pacing with a short atrioventricular delay
Bharani et al. 1312Terminalia Arjuna bark extract
Koreny et al. 1413Milrinone administration
Torre-Amione et al. 1514Prolonged infusion of tezosentan
Mehra et al. 1614Administration of n-3 ethyl ester concentrate (fish oil)
Middlekauff et al. 1715Acupuncture
Nanas et al. 1816Intermittent dobutamine infusions with oral amiodarone
Siegenthaler et al. 1917Long-term continuous axial flow pump support
Sirker et al. 2018Biventricular vs. left univentricular pacing in CRT
Sliwa et al. 2118Pentoxifylline administration
Dai et al. 2218Renal nerve blockade
Nanas et al. 2318Intermittent dobutamine infusions with oral amiodarone
Chen et al. 2418Mechanical ventilation; NPPV vs. ETI
Pacher et al. 2518Prostaglandin E1 infusion
Deswal eta l. 2618Administration of etanercept
Karavidas et al. 2718Positive airway pressure therapy
Fichtlscherer et al. 2818Administration of etanercept
Acevedo et al. 2919Administration of recombinant human growth hormone
Erlemeier et al. 3020Intermittent infusion of dobutamine
Chung et al. 3120Serial home infusions of nesiritide
Cobb et al. 3222Atrioventricular or interventricular delay programming in CRT
Wieselthaler et al. 3323Implantation of LVAD with magnetically levitated rotor
Hamilton et al. 3423Intravenous administration of triiodothyronine
Livi et al. 3524Implantation of Acorn CorCapTM cardiac support device
Roveda et al. 3624Exercise training
Parissis et al. 3725Serial levosimendan infusions
Stellbrink et al. 3825CRT using hemodynamically optimized pacing
Yu et al. 3925Delayed regional contraction after biventricular pacing in CRT
Tasal et al. 4029Single-dose vs. repeated infusions of levosimendan
Wimmer et al. 4130Infusions of prostaglandin E1 and dobutamine
Yu et al. 4230Cardiac contractility modulation
Berman et al. 4332Administration of coenzyme Q10
Acar et al. 4432Administration of oral and intravenous molsidomine
Frey et al. 4532Intravenous prostaglandin E1 vs. dobutamine
Newton et al. 4632Administration of nebulized furosemide
Quittan et al. 4733Neuromuscular electrical stimulation of thigh muscles
Malfatto et al. 4833Intermittent levosimendan infusions
Sueta et al. 4933Continual portable administration of intravenous epoprostenol
Oliva et al. 5038Intermittent low-dose dobutamine infusions
Schalcher et al. 5138Intravenous infusions of tezosentan
Jessup et al. 5239Percutaneous administration of gene therapy
Parissis et al. 5339Administration of levosimendan infusions
Zsebo et al. 5439Gene transfer
Bocchi et al. 5540Administration of granulocyte-colony stimulating factor
Ritzema et al. 5640Physician-directed patient self-management system
Moser et al. 5740Biofeedback-relaxation techniques for voluntary vasocontrol
MacDonald et al. 5841Radiofrequency ablation for persistent atrial fibrillation
Caponnetto et al. 5942Administration of ibopamine
Res et al. 6042Bifocal right biventricular pacing in CRT
Hülsmann et al. 6143Administration of atenolol
Paraskevaidis et al. 6243Administration of carvedilol
Flevari et al. 6345Administration of levosimendan
Bozkurt et al. 6447Sustained administration of etanercept
Krum et al. 6549Administration of carvedilol
Neelagaru et al. 6649Cardiac contractility modulation
Mavrogeni et al. 6750Intermittent levosimendan infusion
Nakamura et al. 6850Administration of angiotensin-converting enzyme inhibitors
Copie et al. 6952Administration of bisoprolol
Keith et al. 7056Vitamin E supplementation
Palazzuoli et al. 7158Administration of carvedilol
Pasqui et al. 7258Administration of levosimendan
Mozid et al. 7358Variable delivery methods of bone marrow-derived stem cells
Palazzuoli et al. 7459Administration of carvedilol
Paterna et al. 7560Combination high-dose furosemide and hypertonic saline
Tziakas et al. 7660Administration of levosimendan
Bonios et al. 7763Intermittent infusions of levosimendan and dobutamine
Stanek et al. 7868Prostaglandin E1 vs. prostacyclin vs. low-dose dobutamine
Morshuis et al. 7968Implantation of magnetically levitated centrifugal LVAD
Evangelista et al. 8071Exercise training
Mehra et al. 8171Long-term intravenous milrinone infusions
Haghjoo et al. 8273Right ventricle apex vs. high septum lead placement in CRT
Tang et al. 8374High- vs. low-dose enalapril
Torre-Amione et al. 8475Non-pharmacological immune modulation therapy
Cole et al. 8576Hospital visits with therapy dog
Stellbrink et al. 8677Univentricular pacing in CRT
Vrtovec et al. 8780Administration of atorvastatin
Morshuis et al. 8882Implantation of magnetically levitated centrifugal LVAD
Troughton et al. 8984Left atrial pressure sensing system and CRT
Bleeker et al. 9090Tissue Doppler imaging in CRT candidates
Imamura et al. 91100Administration of tolvaptan
Studies with 101-1000 participants
Gras et al. 92103Atrio-biventricular transvenous pacing system in CRT
Fonarow et al. 93104Captopril vs. hydralazine plus isosorbide dinitrate
Cohn et al. 94105Administration of carvedilol
Altenberger et al. 95120Pulsed infusions of levosimendan
Braun et al. 96124Implantation and utilization of CRT
Loh et al. 97125Intravenous milrinone vs. intravenous nitroglycerin
Rose et al. 98129Long-term use of LVAD
Jaarsma et al. 99132Supportive educational nursing interventions
Miller et al. 100133Continuous-flow LVAD as bridge to transplantation
Shah et al. 101137B-type natriuretic peptide-guided diuretic therapy
Kurtz et al. 102138Automated home telephone self-monitoring
Udelson et al. 103142Administration of conivaptan
Boriani et al. 104148Remote monitoring of patients implanted with CRT-D devices
Cowley et al. 105151Administration of enoximone
Meyns et al. 106160Partial vs. full support LVAD as bridge to transplantation
Lennie et al. 107175Dietary changes in sodium, lycopene, and omega-3 fatty acids
Anderson et al. 108189Extended infusions of intravenous milrinone
Slaughter et al. 109200Continuous- vs. pulsatile-flow LVAD
Rogers et al. 110200Implantation of mechanically assisted circulation device
Feldman et al. 111201Administration of low-dose oral enoxinome
Yancy et al. 112210Serial nesiritide infusions in outpatients
García-González et al. 113213Administration of intermittent repeated levosimendan infusions
Frey et al. 114236Hemodynamic stability-based staged medical therapy
Greenberg et al. 115250Intracoronary delivery of gene therapy
Bourge et al. 116274Continuous intracardiac pressure monitoring
Goldberg et al. 117280Daily electronic home weight monitoring system
Slaughter et al. 118332Ventricular assist device as bridge to transplantation
Schuchert et al. 119366Cardiac resynchronization therapy in symptomatic patients
Lahpor et al. 120411Implantation of continuous-flow ventricular assist device
Kadish et al. 121428Cardiac contractility modulation
Adams et al. 122430Administration of intravenous epoprostenol
Shah et al. 123500Pulmonary artery catheterization and hemodynamic monitoring
Abraham et al. 124500Utilization of cardiac resynchronization therapy
Glick et al. 125822Administration of aldactone
Yancy et al. 126900Serial infusions of nesiritide
Studies with >1000 participants
Deswal et al. 1271046Administration of vesnarinone
Taylor et al. 1281050Administration of isosobride dinitrate and hydralazine
Eichhorn et al. 1291068Monitoring magnesium levels with milrinone therapy
O'Connor et al. 1301153Administration of amlodipine
Bristow et al. 1311520Cardiac resynchronization therapy with defibrillation
Metra et al. 1321854Administration of low-dose oral enoximone
Hampton et al. 1331906Administration of oral ibopamine
The BEST Investigators1342708Administration of bucindolol
BEST: Beta-Blocker Evaluation of Survival Trial; CRT: cardiac resynchronization therapy; CRT-D: cardiac resynchronization therapy with implantable cardioverter-defibrillator; ETI: endotracheal intubation; LVAD: left ventricular assist device; NPPV: noninvasive positive-pressure ventilation.
Supplemental Table 2. Criteria Used to Define Advanced Heart Failure in Clinical Trials with ≥200 participants (N=27)
Criteria / N of trials with criterion required (%) / Range ofcutoff value / Mode of
cutoff value
New York Heart Association class / 27 (100) / II to IV / III-IV
Left ventricular ejection fraction, % / 21 (77.8) / <20 to <40 / <35
Specific HF symptoms present / 5 (18.5) / --- / ---
Inotrope-dependent status / 2 (7.4) / --- / ---
Previous HF admission / 8 (29.6) / --- / ---
Peak VO2 (ml/kg/min) / 2 (7.4) / <12 to <14 / ---
Cardiac index (L/m2/min) / 1 (3.7) / <2.5 / ---
PCWP (mmHg) / 3 (11.1) / ≥15 to >20 / ---
QRS prolongation (ms) / 2 (7.4) / ≥120 to >130 / ---
LVEDD (mm/m2) / 3 (11.1) / ≥55 to >65 / ---
6-min walk test (m) / 3 (11.1) / <300 to <400 / <400
BNP or NT-proBNP * / 2 (7.4) / --- / ---
Cardiothoracic ratio >0.5 / 1 (3.7) / --- / ---
* N-terminal pro-B-type natriuretic peptide >1200 pg/ml (or >1600 pg/mL if atrial fibrillation present) in 1 study and >3000pg/mL in 1 study. BNP: B-type natriuretic peptide; HF: heart failure; LVEDD: left ventricular end diastolic diameter; NT-proBNP: N-terminal pro-B-type natriuretic peptide;PCWP: pulmonary capillary wedge pressure
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