heart failure with preserved and impaired systolic left ventricular function in allhat jb kostis, b...
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Heart Failure With Preserved And Heart Failure With Preserved And Impaired Systolic Left Ventricular Impaired Systolic Left Ventricular
Function In ALLHATFunction In ALLHAT
JB Kostis, B Davis, L Simpson, H Black, W Cushman, JB Kostis, B Davis, L Simpson, H Black, W Cushman, P Einhorn, M Farber, C Ford, D Levy, B Massie, S NawazP Einhorn, M Farber, C Ford, D Levy, B Massie, S Nawaz
For The ALLHAT Collaborative Research GroupFor The ALLHAT Collaborative Research Group
ALLHAT
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AntihypertensiveTrial Design
• Randomized, double-blind, multi-center clinical trial
• Determine whether occurrence of fatal CHD or nonfatal MI is lower for high-risk hypertensive patients treated with newer agents (CCB, ACEI, alpha-blocker) compared with a diuretic
• 42,418 high-risk hypertensive patients ≥ 55 years
ALLHAT
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Randomized Design of ALLHAT BP Trial
42,41842,418
High-risk High-risk hypertensive hypertensive patientspatients
Consent / Consent / RandomizeRandomize
AmlodipineAmlodipine
ChlorthalidoneChlorthalidone
DoxazosinDoxazosin
LisinoprilLisinopril
Follow until death or end of study (4-8 years, mean 4.9 years)Follow until death or end of study (4-8 years, mean 4.9 years)
ALLHATALLHAT
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Rationale for the Heart Failure Rationale for the Heart Failure Validation Study: BackgroundValidation Study: Background
Early termination of the doxazosin arm February 2000, due to:Early termination of the doxazosin arm February 2000, due to: 25% higher risk of CVD events in doxazosin compared to 25% higher risk of CVD events in doxazosin compared to
chlorthalidone, mostly driven by two-fold increase in HFchlorthalidone, mostly driven by two-fold increase in HF a very low probability of finding a significant difference for a very low probability of finding a significant difference for
the primary outcome by the scheduled trial endthe primary outcome by the scheduled trial end
Higher risk of HF in amlodipine and lisinopril arms compared Higher risk of HF in amlodipine and lisinopril arms compared with chlorthalidonewith chlorthalidone
ALLHAT DSMB recommended that this study be doneALLHAT DSMB recommended that this study be done
Early termination of the doxazosin arm February 2000, due to:Early termination of the doxazosin arm February 2000, due to: 25% higher risk of CVD events in doxazosin compared to 25% higher risk of CVD events in doxazosin compared to
chlorthalidone, mostly driven by two-fold increase in HFchlorthalidone, mostly driven by two-fold increase in HF a very low probability of finding a significant difference for a very low probability of finding a significant difference for
the primary outcome by the scheduled trial endthe primary outcome by the scheduled trial end
Higher risk of HF in amlodipine and lisinopril arms compared Higher risk of HF in amlodipine and lisinopril arms compared with chlorthalidonewith chlorthalidone
ALLHAT DSMB recommended that this study be doneALLHAT DSMB recommended that this study be done
ALLHAT
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Heart Failure Validation Study: Heart Failure Validation Study: Design and MethodsDesign and Methods
Protocol developed in collaboration with heart failure Protocol developed in collaboration with heart failure experts.experts.
Additional documentation collected for all hospitalized Additional documentation collected for all hospitalized heart failure events.heart failure events.
Documentation reviewed by cardiology fellows (blinded to Documentation reviewed by cardiology fellows (blinded to treatment assignment), for signs, symptoms, past history, treatment assignment), for signs, symptoms, past history, concomitant conditions, procedures, treatments.concomitant conditions, procedures, treatments.
Analyses performed using computer algorithm to Analyses performed using computer algorithm to determine whether each case met ALLHAT or determine whether each case met ALLHAT or Framingham criteria.Framingham criteria.
Protocol developed in collaboration with heart failure Protocol developed in collaboration with heart failure experts.experts.
Additional documentation collected for all hospitalized Additional documentation collected for all hospitalized heart failure events.heart failure events.
Documentation reviewed by cardiology fellows (blinded to Documentation reviewed by cardiology fellows (blinded to treatment assignment), for signs, symptoms, past history, treatment assignment), for signs, symptoms, past history, concomitant conditions, procedures, treatments.concomitant conditions, procedures, treatments.
Analyses performed using computer algorithm to Analyses performed using computer algorithm to determine whether each case met ALLHAT or determine whether each case met ALLHAT or Framingham criteria.Framingham criteria.
ALLHAT
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Heart failure developing in patients with hypertension is Heart failure developing in patients with hypertension is associated either with preserved or with impaired left associated either with preserved or with impaired left ventricular systolic function.ventricular systolic function.
ALLHAT provides the to examine occurrence and ALLHAT provides the to examine occurrence and differences in symptoms, signs and case fatality of heart differences in symptoms, signs and case fatality of heart failure with preserved or impaired left ventricular systolic failure with preserved or impaired left ventricular systolic function.function.
Heart failure developing in patients with hypertension is Heart failure developing in patients with hypertension is associated either with preserved or with impaired left associated either with preserved or with impaired left ventricular systolic function.ventricular systolic function.
ALLHAT provides the to examine occurrence and ALLHAT provides the to examine occurrence and differences in symptoms, signs and case fatality of heart differences in symptoms, signs and case fatality of heart failure with preserved or impaired left ventricular systolic failure with preserved or impaired left ventricular systolic function.function.
IntroductionIntroduction
HF With Preserved And Impaired Systolic Left Ventricular FunctionALLHAT
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HF With Preserved And Impaired HF With Preserved And Impaired Systolic Left Ventricular FunctionSystolic Left Ventricular Function
To verify the heart failure outcomes of ALLHAT, all To verify the heart failure outcomes of ALLHAT, all available hospitalized heart failure events reported by available hospitalized heart failure events reported by ALLHAT Investigators were systematically reviewed. ALLHAT Investigators were systematically reviewed.
Estimate of left ventricular ejection fraction by contrast Estimate of left ventricular ejection fraction by contrast ventriculography, echocardiography or radionuclide ventriculography, echocardiography or radionuclide study was available in 928 (66%) of 1,300 first study was available in 928 (66%) of 1,300 first hospitalized heart failure events meeting ALLHAT hospitalized heart failure events meeting ALLHAT criteria.criteria.
To verify the heart failure outcomes of ALLHAT, all To verify the heart failure outcomes of ALLHAT, all available hospitalized heart failure events reported by available hospitalized heart failure events reported by ALLHAT Investigators were systematically reviewed. ALLHAT Investigators were systematically reviewed.
Estimate of left ventricular ejection fraction by contrast Estimate of left ventricular ejection fraction by contrast ventriculography, echocardiography or radionuclide ventriculography, echocardiography or radionuclide study was available in 928 (66%) of 1,300 first study was available in 928 (66%) of 1,300 first hospitalized heart failure events meeting ALLHAT hospitalized heart failure events meeting ALLHAT criteria.criteria.
Methods
ALLHAT
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HF With Preserved And Impaired Systolic Left Ventricular FunctionALLHAT
45%
55%
HF by EF level <50% vs. >50%
N=928
EF>50%EF<50%
45%
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HF With Preserved And Impaired Systolic Left Ventricular Function
29%
12%25%
34%
ALLHAT
HF by EF level N=1399
EF N/A
EF<40%
EF>50%
EF 40-49%
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37%
18%
45%37%
HF With Preserved And Impaired Systolic Left Ventricular FunctionALLHAT
HF by EF level(% of those with available EF) N=928
EF<40%
EF 40-49%
EF>50%
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HF With Preserved And Impaired Systolic Left Ventricular Function
BaselineCharacteristics
Normal ImpairedP value
Normal vsImpaired
Total ALLHAT
Age 69.7 69.6 0.91 66.9
Ethnicity White non-Hispanic Black non-Hispanic Other
60.9% 31.5%7.6%
58.5% 34.2%7.3%
0.75 47.1%32.3%4.9%
Women 51.2% 37.5% <0.001 46.8%
Current Smoker 18.7% 19.2% 0.86 21.9%
Treated 95.0% 92.5% 0.12 90.2%
Atherosclerotic CVD 61.4% 64.4% 0.34 51.6%
ST dep. or T Wave Invers. 11.1% 12.2% 0.39 10.3%
Type II Diabetes 50.2% 50.2% 0.99 36.0%
LVH by ECG 18.7% 20.6% 0.48 16.4%
LVH by ECHO 6.6% 4.9% 0.27 4.5%
ALLHAT
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HF With Preserved And Impaired Systolic Left Ventricular Function
BaselineCharacteristics
Normal ImpairedP value
Normal vs.Impaired
Total ALLHAT
History of CHD 32.5% 38.2% 0.07 25.6%Blood PressureSBP meanDBP mean
149.680.7
147.981.6
0.100.18
146.384.0
Fasting Glucose mean>126 mg/dL
140.840.5%
144.046.7%
0.650.10
123.029.1%
LDL mean 133.4 137.5 0.14 135.8HDL mean<35 mg/dL
45.222.1%
42.529.3%
0.0030.02
46.819.2%
Triglyceride mean 182.7 189.8 0.44 175.7
ALLHAT
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Symptoms ofHeart Failure
Normal ImpairedP value
Normal vs.Impaired
%Missing
PND 29.4% 35.8% 0.04 56.5%
Orthopnea 41.7% 45.5% 0.25 45.8%
Dyspnea at rest 50.7% 49.6% 0.73 45.6%
DOE 69.0% 67.4% 0.61 30.9%
NYHA Class III 64.0% 57.1% 0.03 39.2%
Night Cough 11.6% 8.1% 0.07 82.0%
HF With Preserved And Impaired Systolic Left Ventricular FunctionALLHAT
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Signs of Heart Failure Normal Impaired
P valueNormal vs.Impaired
%Missing
Ankle Edema 2+ 37.9% 26.5% 0.0002 15.3%
Bilateral Ankle Edema 67.1% 54.2% 0.0001 10.9%
Tachycardia 120+ 11.8% 13.4% 0.47 28.7%
Jugular Venous Distention 36.3% 37.2% 0.78 28.2%
Increased Venous Pressure >8 AND <16 CM H2O 10.9% 9.5% 0.48 61.6%
Hepatojugular Reflux 2.6% 4.3% 0.15 90.9%
Rales 73.7% 76.5% 0.33 11.5%
S3 Gallop 10.0% 19.6% <0.0001 39.9%
Hepatomegaly 2.4% 5.7% 0.01 50.4%
Cardiomegaly 60.0% 62.8% 0.37 27.7%
HF With Preserved And Impaired Systolic Left Ventricular FunctionALLHAT
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Signs of Heart Failure Normal Impaired
P value Normal vs.Impaired
%Missing
Acute Pulmonary EdemaNo
28.4%13.7%
30.6%14.2%
0.47 56.4%
Pleural EffusionNo
35.1%16.4%
40.7%13.2%
0.08 47.2%
Pulmonary VascularEngorgementRedistribution
39.6%16.4%
37.2%22.1%
0.450.03
54.1%73.9%
X-Ray Characteristic of HFReviewer OpinionReport
48.3%50.7%
52.6% 55.5%
0.200.14
39.9%36.6%
HF With Preserved And Impaired Systolic Left Ventricular FunctionALLHAT
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26.5 41.6 31.9
28.6 39.9 31.4
28.6 39.4 31.9
33.7 33.2 34.7
29.9 23.3 36.2
0% 20% 40% 60% 80% 100%
CHLOR
DOX
.
CHLOR
AML
LIS*
NL EF Low EF EF N/A
EF Range by Drug
HF With Preserved And Impaired Systolic Left Ventricular FunctionALLHAT
*lisinopril vs. chlorthalidone p=0.04
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38.9 61.1
41.7 58.2
42.1 57.9
46.9 53.1
52.6 47.4
0% 20% 40% 60% 80% 100%
CHLOR
DOX
.
CHLOR
AML
LIS*
NL EF Low EF
EF Range by Drug; % of Those With Available EF
HF With Preserved And Impaired Systolic Left Ventricular FunctionALLHAT
* lis vs. chlor, p=0.02
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24.8
3.4
30.3
6.8
0.0
5.010.0
15.0
20.025.0
30.0
35.040.0
NL EF Low EF
Death after HF Death with HF
Vital Status (% Dead)
28.1
37.1P=0.004
P=0.02
P=0.06
HF With Preserved And Impaired Systolic Left Ventricular Function
ALLHAT Total
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0
20
40
60
80
CHLOR AML LIS
NL EF
Low EF
p=0.22p=0.001 p=0.31
Vital Status by Drug and EF Group
HF With Preserved And Impaired Systolic Left Ventricular Function
ALLHAT
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Cumulative HF Rate Among All HF Cases Using ALLHAT Criteria;
With EF by EF Class
0.00
0.20
0.40
0.60
0.80
1.00
Co
nd
itio
nal
Cu
mu
lati
ve A
LL
HA
T#1
HF
Rat
e
0 1 2 3 4 5 6 7
Time to event, y
>50%40 - 49%<40%
ALLHAT
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Cumulative HF Rate Among All HF Cases Using ALLHAT Criteria;
With EF by EF Class
0.00
0.20
0.40
0.60
0.80
1.00
Co
nd
itio
nal
Cu
mu
lati
ve A
LL
HA
T#1
HF
Rat
e
0 1 2 3 4 5 6 7
Time to event, y
Normal (EF>50)
Impaired (EF<50)
ALLHAT
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Cumulative HF Rate Using ALLHAT Criteria; With EF<50
0.00
0.01
0.02
0.03
Cu
mu
lati
ve A
LL
HA
T#1
HF
Rat
e
0 1 2 3 4 5 6 7
Time to event, y
ChlorthalidoneAmlodipineLisinopril
RR (95%CI) P value
A/C 1.28 (1.02-1.61) 0.03
L/C 0.90 (0.70-1.16) 0.43
ALLHAT
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Cumulative HF Rate Using ALLHAT Criteria; With EF>50
0.00
0.01
0.02
0.03
Cu
mu
lati
ve A
LL
HA
T#1
HF
Rat
e
0 1 2 3 4 5 6 7
Time to event, y
ChlorthalidoneAmlodipineLisinopril
ALLHAT
RR (95%CI) P value
A/C 1.56 (1.21-2.01) 0.0005
L/C 1.38 (1.06-1.80) 0.02
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Cumulative HF Rate Using ALLHAT Criteria; With EF<50
0.00
0.01
0.02
Cu
mu
lati
ve A
LL
HA
T#1
HF
Rat
e
0 1 2 3 4
Time to event, y
ChlorthalidoneDoxazosin
ALLHAT
RR (95% CI) P value
D/C 1.64 (1.27-2.12) 0.0001
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Cumulative HF Rate Using ALLHAT Criteria; With EF>50
0.00
0.01
0.02
Cu
mu
lati
ve A
LL
HA
T#1
HF
Rat
e
0 1 2 3 4
Time to event, y
Chlorthalidone
Doxazosin
RR (95% CI) P value
D/C 1.84 (1.35-2.52) 0.0001
ALLHAT
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Post-HF Mortality With Preserved Systolic Function (EF >50)
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
Cu
mu
lati
ve P
ost
-HF
Mo
rtal
ity
Rat
e
0 1 2 3 4 5 6
Time to event, y
ChlorthalidoneAmlodipineLisinopril
RR (95%CI) P value
A/C 0.70 (0.46-1.07) 0.10
L/C 1.07 (0.74-1.54) 0.73
ALLHAT
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Post-HF Mortality With Impaired Systolic Function (EF<50)
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
Cu
mu
lati
ve P
ost
-HF
Mo
rtal
ity
Rat
e
0 1 2 3 4 5 6
Time to event, y
ChlorthalidoneAmlodipineLisinopril
RR (95%CI) P value
A/C 1.08 (0.82-1.42) 0.59
L/C 1.06 (0.78-1.44) 0.72
ALLHAT
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Post-HF Mortality With Preserved Systolic Function (EF >50)
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
Cu
mu
lati
ve P
ost
HF
Mo
rtal
ity
Rat
e
0 1 2 3 4
Time to event, y
Doxazosin
Chlorthalidone
RR (95% CI) P value
D/C 0.86 (0.47-1.58) 0.62
ALLHAT
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Post-HF Mortality With Impaired Systolic Function (EF<50)
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
Cu
mu
lati
ve P
ost
-HF
Mo
rtal
ity
Rat
e
0 1 2 3 4
Time to event, y
Doxazosin
Chlorthalidone
RR (95% CI) P value
D/C 0.73 (0.47-1.14) 0.17
ALLHAT
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Post-HF Mortality By Systolic Function
0.00
0.10
0.20
0.30
0.40
0.50
0.60
0.70
0.80
Cu
mu
lati
ve A
LL
HA
T#1
HF
to
Dea
th R
ate
0 1 2 3 4 5 6Time to Event, y
Preserved Systolic Function (EF >50)
Impaired Systolic Function (EF <50)
ALLHAT
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Heart Failure with preserved left ventricular systolic Heart Failure with preserved left ventricular systolic
function is common in treated patients with function is common in treated patients with hypertension (compared to heart failure with impaired hypertension (compared to heart failure with impaired systolic function).systolic function).
Heart Failure with preserved left ventricular systolic Heart Failure with preserved left ventricular systolic function is associated with more edema while heart function is associated with more edema while heart failure with impaired left ventricular systolic function is failure with impaired left ventricular systolic function is associated with signs of ventricular dilatation.associated with signs of ventricular dilatation.
Heart Failure with preserved left ventricular systolic Heart Failure with preserved left ventricular systolic function is associated with lower case fatality (than function is associated with lower case fatality (than heart failure with impaired systolic function).heart failure with impaired systolic function).
Heart Failure with preserved left ventricular systolic Heart Failure with preserved left ventricular systolic
function is common in treated patients with function is common in treated patients with hypertension (compared to heart failure with impaired hypertension (compared to heart failure with impaired systolic function).systolic function).
Heart Failure with preserved left ventricular systolic Heart Failure with preserved left ventricular systolic function is associated with more edema while heart function is associated with more edema while heart failure with impaired left ventricular systolic function is failure with impaired left ventricular systolic function is associated with signs of ventricular dilatation.associated with signs of ventricular dilatation.
Heart Failure with preserved left ventricular systolic Heart Failure with preserved left ventricular systolic function is associated with lower case fatality (than function is associated with lower case fatality (than heart failure with impaired systolic function).heart failure with impaired systolic function).
Conclusions
HF With Preserved And Impaired Systolic Left Ventricular Function
ALLHAT