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Landmark Trials in Heart Failure > Heart Failure > Flashcards

Heart Failure Flashcards

1
Q

VEHFT-1

A

1st RCT with survival endpoint (improved survival with Hydralazine/ISDN)

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2
Q

VEHFT-2

A

FIRST study to demonstrate difference between ACE-I vs Hydralazine/ISDN (Enalapril superior to hydralazine/ISDN for survival); showed difference between vasodilators and ACE-I

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3
Q

PRAISE-4

A
  • Amlodipine vs placebo (Amlodipine = placebo for survival)

- 1st to show safety of CCB in CHF

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4
Q

CONSENSUS-1 (1987)

A

Compared Enalapril vs placebo on top of digoxin + diuretic in NYHA IV (Enalapril superior to placebo for survival)

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5
Q

SOLVD

A

Enalapril vs placebo in NYHA II/III : (Enalapril superior to placebo for survival)

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6
Q

SOLVD-P

A

Enalapril vs placebo in NYHA I/II (Enalapril superior to placebo)

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7
Q

SAVE

A

Captopril vs placebo in post-MI pxs with LV dysfunction (Captopril superior to placebo for survival and CHF onset), FIRST trial to demonstrate remodeling hypothesis

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8
Q

AIRE

A

Ramipril vs placebo in HF after MI (improved survival with Ramipril), confirmed results of SAVE

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9
Q

MDC

A

Metoprolol vs placebo in NYHA II/III (Metoprolol equal with placebo in terms of survival but showed improved clinical status)
FIRST multicentre clinical trial to assess beta blocker

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10
Q

CIBIS-II

A

Bisoprolol vs placebo in NYHA III/IV (Bisoprolol showed reduced mortality)

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11
Q

CIBIS III

A

Outcomes did not vary when either ACEi or beta blocker was initiated first

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12
Q

MERIT

A

Metoprolol CR/XL with ACE-I (significant reduction in mortality with combination) ; further strengthened the role of of beta blocker in HF

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13
Q

COPERNICUS

A

Carvedilol vs placebo on top of standard medical tx, showed reduced CV death and hospitalization

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14
Q

SENIORS

A

Nebivolol vs placebo in pxs >=70y/o (no difference in all-cause mortality but showed safety for use in elderly)

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15
Q

ELITE

A

looked at the role of ARB in HF. Compared Losartan vs Captopril- found similar results but study was not designed as a superiority study, hence ACE-I is still the drug of choice

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16
Q

VAL-Heft

A

Valsartan vs placebo on top of ACE-I (showed added benefit in reducing hospitalization in HF)

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17
Q

A-Heft

A

ISDN + hydralazine

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18
Q

CHARM-ADDED

A

Candesartan on top of standard medical tx (showed added benefit of ARB on top of ACE-I + BB in hospitalization and mortality)

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19
Q

VALIANT

A

Valsartan was noninferior to captopril on all-cause mortality

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20
Q

RALES

A

Spironolactone on top of ACE-I, diuretic, digoxin in NYHA III/IV. Showed reduced overall mortality, hospitalization, and progressive HF. Established the role of aldosterone blocker in severe HF

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21
Q

EPHESUS

A

Eplerenone on top of standard tx (showed reduced overall CV mortality and hospitalization for CV events)

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22
Q

EMPHASIS-HF

A

Eplerenone on top of standard tx for HF with mild symptoms (showed improved CV mortality and hospitalization for HF)

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23
Q

SHIFT

A

Ivabradine vs placebo on top of standard tx for pxs with EF <35%. Showed reduced CV death and hospitalizion

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24
Q

PARADIGM-HF

A

role of angiotensin receptor-neprilysin inhibitor (ARNI) vs Enalapril for pxs with EF <=35%, NYHA Class II-IV. showed reductions in all-cause mortality, CV mortality, and HF hospitalizations with use of ARNI (Sacubitril/valsartan). Not routinely recommended starting HefRef pxs on ARNIs in pxs with NYHA class II or III who are tolerating ACE-I or ARB, but may be used as a replacement to further reduce mortality

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25
Q

PARAMOUNT

A

ARNI vs Valsartan alone. Double blind RCT in pxs with NYHA Class II/III with EF >45%. Showed improved NYHA functional class with ARNI versus valsartan alone

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26
Q

TOPCAT

A

MRAs shown to improve measures of diastolic function and exercise capacity in HFpEF patients

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27
Q

CHAMPION

A

showed that modifying treatment based on data obtained from implantable hemodynamic monitors (IHMs) will lower HF events in HFpEF pts

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28
Q

EVEREST

A

NYHA Class III/IV hospitalized for worsening HF showed that oral tolvaptan in addition to standard tx improved many, but not all signs and symptoms of HF, without adverse events. But no effect in all cause mortality or composite of cardiovascular death or hospitalization for HF with long term tx

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29
Q

I-PRESERVE

A

no differences and in meaningful endpoints in hfpef patients treated with Irbesartan

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30
Q

RELAX

A

Sildenafil, no improvement in functional capacity, quality of life, or other clincial and surrogate parameters

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31
Q

RELAX-AHF

A

Serelaxin vs placebo, relaxin improved dyspnea, reduced signs of congestion, with less early worsening of HF

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32
Q

TRUE-AHF

A

Ularitide: no improvement over clinical outcomes at 6 mos, associated with higher rate of hypotension and worsening of serum creatinine

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33
Q

ALDO-DHF

A

Spironolactone improved echocardiographic indices of diastolic dysfunction but failed to improve exercise capacity, symptoms, or QOL measures

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34
Q

NEAT-HFpEF

A

ISMN did not improve QOL or submaximal exercise capacity, and decreased overall activity levels in treated patients

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35
Q

PARAGON-HF

A

LCZ696 (ARB with endopeptidase inhibitor) shown to reduce circulating natriuretic peptides and reduce left atrial size to a greater extent than Valsartan alone in patients with HFpEF

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36
Q

CARRESS-HF

A

UF vs stepped pharmacologic care: worsening in creatinine in UF group, more adverse events in UF group including kidney failure, bleeding complications and IV catheter related complications

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37
Q

ASCEND-HF

A

Nesiritide+placebo on top of standard care:clinically insiginificant benefit on dyspnea, increased rates of hypotension

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38
Q

REVIVE II

A

reduced arrhythmias and improved survival with Levosimendan compared to placebo and dobutamine

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39
Q

SURVIVE

A

Levosimendan vs dobutamine – Levosimendan did not reduce all-cause mortality or any secondary clinical outcomes

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40
Q

PROTECT

A

Rolofylline (Selective A1 adenosine receptor antagonist)

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41
Q

COSMIC-HF

A

Omecamtiv mecarbil

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42
Q

ASTRONAUT

A

Aliskiren (direct renin inhibitor) – no significant difference in cardiovascular death or hospitalization at 6 or 12 months

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43
Q

OVERTURE

A

Omapatrilat+neutral endopeptidase inhibitor: this drug did not favorably influence the primary outcome measure of the combined risk of death or hospitalization for HF

44
Q

CORONA & GISSI-HF

A

low dose Rosuvastatin in pts with HFrEF demonstrated no improvement in aggregrate clinical outcomes

45
Q

WARCEF

A

full-dose ASA or INR-controlled warfarein – no significant difference in the primary outcome; a reduced risk of ischemic stroke with warfarin was offset by an increased risk of major hemorrhage

46
Q

CARE-HF

A

first study to demonstrate a reduction in all-cause-mortality with CRT placement in patients with HFrEF on optimal therapy

47
Q

PEP-HF

A

Perindopril in Elderly People with Chronic Heart Failure

48
Q

3CPO

A

NIV with cpap or nippv was associated with greater improvement in patient-reported dyspnea, HR, acidosis, and hypercapnea after 1 hour of therapy, although it was not associated with a 7-day mortality benefit or a decreased need for intubation

49
Q

ESCAPE

A

Use of pulmonary artery catheter (PAC) did not significantly affect the days alive and out of hospital during the first 6 months

50
Q

DOSE

A

initial dose of 2.5x the OPD dose of diuretics should be considered for patients receiving chronic oral diuretic therapy, with underlying renal dysfunction, or with severe overload

51
Q

ALARM-HF

A

diuretics + vasodilators had significantly better in-hospital survival than patients treated with diuretics alone in patients with AHF

52
Q

VMAC

A

decompensated CHF and dyspnea randomized to placebo, nitroglycerin and nesiritide, pts receiving nesiritide had a significantly greater decrease in PCWP

53
Q

ROSE-AHF

A

Nesiritide had no beneficial effect on urine output or cystatin C or on any of the other secondary endpoints reflective; low dose dopamine did not increase urine volume

54
Q

CASINO

A

significantly increased mortality with dobutamine compared to placebo

55
Q

DAD-HF

A

suggested that low dose furosemide + dopamine resulted in comparable urine output and dyspnea relief, but improved renal function profile and potassium homeostasis, compared to high dose furosemide

56
Q

DAD-HF II

A

no beneficial effect of the addition of low dose dopamine to furosemide

57
Q

OPTIME-CHF

A

milrinone or placebo-no difference in the primary endpoint of days hospitalized for cardiovascular causes with 60 days, but significant increases in sustained hypotension and new atrial arrhythmias were noted in the milrinone-treated patients

58
Q

SOAP II

A

dopamine or NE with a non-statistical difference increase in mortality with dopamine associated with a significant increase in arrhythmic events; subgroup analysis including the 280 patients with cardiogenic shock, NE had improved survival compared to dopamine

59
Q

UNLOAD

A

Patients receiving ultrafiltration demonstrated a greater reduction in body weight at 48 hours, but no improvements in dyspnea or renal function; Intriguingly, there was a reduction in postdischarge events at 90 days with ultrafiltration, although the number of events was small.

60
Q

CARRESS

A

randomized 188 patients with AHF, WRF, and persistent congestion to a strategy of stepped pharmacologic care (IV diuretics dosed by investigator to maintain urine output of 3 to 5 L/day plus IV vasodilators or inotropes if needed to achieve target urine output) or ultrafiltration (fluid removal rate, 200 mL/hr; UF resulted in similar weight loss but resulted in an increase in creatinine levels

61
Q

AVOID-HF

A

(Aquapheresis Versus Intravenous Diuretics and Hospitalizations for Heart Failure) there were trends suggesting longer time to first HF event and fewer HF and cardiovascular events in the adjustable ultrafiltration group compared to those randomized to adjustable IV loop diuretics. There was no difference in renal function, but more patients assigned to ultrafiltration experienced adverse events

62
Q

SMAC-HF

A

HSS (150 mL 3% normal saline [NS]) plus furosemide (250-mg IV bolus twice daily) and sodium restriction to 120 mmol/day versus furosemide (250-mg IV bolus twice daily) and sodium restriction to 80 mmol/day; There was a shorter LOS, increased creatinine clearance at discharge, reduced readmission rate, and improved survival for patients in the HSS group.

63
Q

VERITAS

A

addition of IV tezosentan to standard therapy did not improve symptoms nor decrease worsening HF or mortality at 7 days after randomization

64
Q

BLAST-AHF

A

TRV027 conferred no benefit over placebo at any dose with regard to the primary composite endpoint or any of the individual components, although there were no significant safety issues.

65
Q

SOCRATES-Reduced study

A

vericiguat did not significantly improve log-transformed NT-proBNP concentrations compared to placebo, but there was a suggestion of a dose-response effect

66
Q

ATOMIC-AHF

A

IV omecamtiv mecarbil did not meet the primary endpoint of dyspnea improvement compared to the pooled placebo

67
Q

TACTICS

A

Tolvaptan vs placebo - Tolvaptan resulted in greater weight loss and net fluid loss vs placebo but likely to experience worsening renal function

68
Q

HORIZON-HF

A

addition of istaroxime to standard therapy lowered PCWP and heart rate and increased SBP

69
Q

RED-HF

A

Darboietin alfa in heart failure

70
Q

RAPID-CHF

A

FIRST RCT of ultrafilitration for ADHF

71
Q

ELITE-II

A

losartan was not associated with improved survival in elderly HF patients compared to captopril but was significantly better tolerated

72
Q

HEAAL

A

high-dose losartan was not associated with significant reduction in the primary endpoint of patients with HF compared to low-dose losartan, but was associated with a reduction in hospitalization

73
Q

BEST

A

Bucindolol

74
Q

CAPRICORN

A

Carvedilol

75
Q

BEAT

A

Bucindolol

76
Q

COMET

A

Carvedilol was associated with a significant 33% reduction in all-cause mortality compared with Metoprolol tartrate

77
Q

BEAUTIFUL

A

10,000 patients with coronary heart disease and EF <40% were randomized to Ivabradine, this trial did not meet its primary endpoint of reducing CV death, MI, or HF hospitalization, Ivabradine was well tolerated in this patient population

78
Q

ALOFT

A

aliskiren was shown to decrease significantly NT-proBNP in urinary aldosterone

79
Q

ATMOSPHERE

A

same result with ASTRONAUT, clinical trials failed to improve outcomes in HFrEF patients, and renin inhibitors such as aliskiren are not presently recommended as an alternative to an ACEI or ARB or in combination with ACEIs

80
Q

RADIANCE and PROVED

A

Randomized Assessment of Digoxin and Inhibitors of Angiotensin-Converting Enzyme and the Prospective Randomized Study of Ventricular Function and Efficacy of Digoxin (PROVED), provided strong support for clinical benefit from digoxin

81
Q

DIG

A

digoxin had a neutral effect on the primary endpoint of mortality, digoxin reduced hospitalizations

82
Q

GISSI-HF

A

1g/day of omega 3 PUFA resulted in significant reduction in both all-cause mortality

83
Q

GENETIC-AF

A

bucindolol vs metoprolol succinate on recurrence of symptomatic atrial fibrillation/atrial flutter in HF patients

84
Q

STICH

A

CABG did not reduce all cause death

85
Q

ANDROMEDA

A

Drodenarone - two-fold increased mortality in HF patients

86
Q

HF-action

A

exercise training did not have a favorable impact on all-cause mortality or HF hospitalization

87
Q

MUSTIC

A

safety and efficacy of CRT in patients with advanced HF, ventricular dyssynchrony;
FIRST randomized SINGLE-blinded trials of CRT for HF; primary endpoints were exercise tolerance assessed by measurement of peak oxygen consumption (VO2) or the 6-minute hall walk distance (6MHWD) test and quality of life determined using the Minnesota Living with Heart Failure (MLWHF) questionnaire; Secondary endpoints included rehospitalizations and/or drug therapy modifications for worsening HF

88
Q

MIRACLE

A

FIRST prospective, randomized, DOUBLE-blind, parallel- controlled clinical trial designed to evaluate the benefits of CRT; Primary endpoints were NYHA class, quality of life score (using the MLWHF questionnaire), and 6MHWD. Secondary endpoints included assessments of a composite clinical response, cardiopulmonary exercise performance, cardiac structure and function, a variety of measures of worsening HF, and combined morbidity and mortality

89
Q

MIRACLE ICD

A

prospective, multicenter, random- ized, double-blind, parallel-controlled clinical trial intended to assess the safety and efficacy of a combined CRT-ICD system in patients with dilated cardiomyopathy

90
Q

CONTAK CD

A

enrolled 581 symptomatic HF patients with ventricular dyssynchrony and malignant ventricular tachyarrhythmias, who were all candidates for an ICD


91
Q

COMPANION

A

was a multicenter, prospective RCT designed to compare drug therapy alone to drug therapy combined with CRT in patients with dilated cardiomyopathy, an intraventricular conduction defect (IVCD), NYHA Class III or IV HF, and no indication for a device; Compared to optimal medical therapy alone, the combined endpoint of mortality or HF hospitalization was reduced by 35% for patients receiving CRT and 40% for patients receiving CRT-ICD

92
Q

REVERSE

A

the first large, randomized, multicenter trial to demonstrate the potential for CRT to slow progression of disease through reverse remodeling in NYHA Class I and II HF patients with ventricular dyssynchrony.

93
Q

MADIT CRT

A

multicenter RCT designed to address the potential survival and morbidity benefit of CRT in NYHA Class I and II HF patients by assessing the reduction in risk of death and nonfatal HF events; led the FDA to expand the indication for CRT to NYHA Class II or ischemic Class I patients, with LVEF less than 30%, QRS duration longer than 130 milliseconds, and LBBB

94
Q

RAFT

A

FIRST to show a mortality benefit of combined CRT-ICD over an ICD alone, and a mortality reduction with the addition of CRT in patients in NYHA

95
Q

EchoCRT

A

CRT in patients with NYHA Class III or IV HF, LVEF of 35% or less, QRS duration less than 130 milliseconds, and echocardiographic evidence of LV dyssynchrony; demonstrated the potential for harm in using CRT in narrow-QRS patients. Thus, CRT is considered contraindicated in these patients.

96
Q

Landmark trials establishing the role of ICD’s as primary prevention of mortality in HF patients (3)

A

MADIT II
DEFINITE
SCD-HeFT

97
Q

MADIT II

A

prospectively designed and powered to assess the survival benefit of ICDs in a population of post–myocardial infarction (MI) patients with reduced EF (<30%).

98
Q

DEFINITE

A

FIRST RCT of primary prevention therapy with an ICD in nonischemic cardiomyopathy patients

99
Q

SCD-HeFT

A

three-arm trial, comparing treatment with an ICD to amiodarone and placebo; ICD was associated with a statistically significant 23% reduction in all-cause mortality compared to placebo; provides the most robust evidence to date supporting the prophylactic use of an ICD in patients with NYHA Class II and III systolic HF

100
Q

DANISH

A

prophylactic ICD insertion in pts with symptomatic HF not caused by CAD was not associated with significant lower long-term rate of death from any cause than the usual clinical care

101
Q

ISTIMIR

A

evaluating MV replacement and repair for severe ischemic MR demonstrated no difference in short- or long-term mortality between patients cohorts

102
Q

PARTNER

A

demonstrated TAVR to be a safe treatment strategy in high-risk patients LV dysfunction


103
Q

RESTORE

A

(Reconstructive Endoventricular Surgery Returning Torsion Original Radius Elliptical Shape to the Left Ventricle) multicenter study investigated various techniques for LV reconstruction

104
Q

CUPID 2

A

delivery of SERCA 2a for the treatment of heart failure

105
Q

CARVEDILOL-US

A

Carvedilol vs placebo in NYHA II/III
(Carvedilol superior to placebo for morbidity and mortality) However this was not designed as a mortality study
follow-up period was short

Landmark Trials in Heart Failure (1 decks)

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