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ALLHAT. Heart Failure With Preserved And Impaired Systolic Left Ventricular Function In ALLHAT. JB Kostis, B Davis, L Simpson, H Black, W Cushman, P Einhorn, M Farber, C Ford, D Levy, B Massie, S Nawaz For The ALLHAT Collaborative Research Group. ALLHAT. Antihypertensive Trial Design.

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heart failure with preserved and impaired systolic left ventricular function in allhat
ALLHATHeart Failure With Preserved And Impaired Systolic Left Ventricular Function In ALLHAT

JB Kostis, B Davis, L Simpson, H Black, W Cushman,

P Einhorn, M Farber, C Ford, D Levy, B Massie, S Nawaz

For The ALLHAT Collaborative Research Group

antihypertensive trial design
ALLHATAntihypertensiveTrial 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
randomized design of allhat bp trial
ALLHATRandomized Design of ALLHAT BP Trial

42,418

High-risk hypertensive patients

Consent / Randomize

Amlodipine

Chlorthalidone

Doxazosin

Lisinopril

Follow until death or end of study (4-8 years, mean 4.9 years)

rationale for the heart failure validation study background
ALLHATRationale for the Heart Failure Validation Study: Background
  • Early termination of the doxazosin arm February 2000, due to:
    • 25% higher risk of CVD events in doxazosin compared to chlorthalidone, mostly driven by two-fold increase in HF
    • a very low probability of finding a significant difference for the primary outcome by the scheduled trial end
  • Higher risk of HF in amlodipine and lisinopril arms compared with chlorthalidone
  • ALLHAT DSMB recommended that this study be done
heart failure validation study design and methods
ALLHATHeart Failure Validation Study: Design and Methods
  • Protocol developed in collaboration with heart failure experts.
  • Additional documentation collected for all hospitalized heart failure events.
  • Documentation reviewed by cardiology fellows (blinded to treatment assignment), for signs, symptoms, past history, concomitant conditions, procedures, treatments.
  • Analyses performed using computer algorithm to determine whether each case met ALLHAT or Framingham criteria.
slide6
HF With Preserved And Impaired Systolic Left Ventricular Function

ALLHAT

Introduction

  • Heart failure developing in patients with hypertension is associated either with preserved or with impaired left ventricular systolic function.
  • ALLHAT provides the to examine occurrence and differences in symptoms, signs and case fatality of heart failure with preserved or impaired left ventricular systolic function.
hf with preserved and impaired systolic left ventricular function
ALLHATHF With Preserved And Impaired Systolic Left Ventricular Function

Methods

  • To verify the heart failure outcomes of ALLHAT, all available hospitalized heart failure events reported by ALLHAT Investigators were systematically reviewed.
  • Estimate of left ventricular ejection fraction by contrast ventriculography, echocardiography or radionuclide study was available in 928 (66%) of 1,300 first hospitalized heart failure events meeting ALLHAT criteria.
hf with preserved and impaired systolic left ventricular function1
ALLHAT

45%

EF>50%

EF<50%

N=928

HF by EF level <50% vs. >50%

HF With Preserved And Impaired Systolic Left Ventricular Function
hf with preserved and impaired systolic left ventricular function2
ALLHATHF With Preserved And Impaired Systolic Left Ventricular Function

EF>50%

EF N/A

EF 40-49%

EF<40%

N=1399

HF by EF level

slide10
ALLHAT

HF With Preserved And Impaired Systolic Left Ventricular Function

EF<40%

EF>50%

EF 40-49%

HF by EF level

(% of those with available EF)

N=928

slide13
ALLHAT

HF With Preserved And Impaired Systolic Left Ventricular Function

slide16
HF With Preserved And Impaired Systolic Left Ventricular Function

ALLHAT

EF Range by Drug

*lisinopril vs. chlorthalidone p=0.04

slide17
HF With Preserved And Impaired Systolic Left Ventricular Function

ALLHAT

EF Range by Drug; % of Those With Available EF

* lis vs. chlor, p=0.02

slide18
HF With Preserved And Impaired Systolic Left Ventricular Function

ALLHAT

Total

37.1

P=0.004

28.1

P=0.02

P=0.06

Vital Status (% Dead)

slide19
HF With Preserved And Impaired Systolic Left Ventricular Function

ALLHAT

Vital Status by Drug and EF Group

cumulative hf rate among all hf cases using allhat criteria with ef by ef class
ALLHAT

1.00

>50%

40 - 49%

0.80

<40%

0.60

Conditional Cumulative ALLHAT#1 HF Rate

0.40

0.20

0.00

0

1

2

3

4

5

6

7

Time to event, y

Cumulative HF Rate Among All HF Cases Using ALLHAT Criteria; With EF by EF Class
cumulative hf rate among all hf cases using allhat criteria with ef by ef class1
ALLHATCumulative HF Rate Among All HF Cases Using ALLHAT Criteria; With EF by EF Class

1.00

Normal (EF>50)

Impaired (EF<50)

0.80

0.60

Conditional Cumulative ALLHAT#1 HF Rate

0.40

0.20

0.00

0

1

2

3

4

5

6

7

Time to event, y

cumulative hf rate using allhat criteria with ef 50
ALLHAT

Chlorthalidone

Amlodipine

Lisinopril

Cumulative HF Rate Using ALLHAT Criteria; With EF<50

0.03

0.02

Cumulative ALLHAT#1 HF Rate

0.01

0.00

0

1

2

3

4

5

6

7

Time to event, y

cumulative hf rate using allhat criteria with ef 501
ALLHAT

Chlorthalidone

Amlodipine

Lisinopril

Cumulative HF Rate Using ALLHAT Criteria; With EF>50

0.03

0.02

Cumulative ALLHAT#1 HF Rate

0.01

0.00

0

1

2

3

4

5

6

7

Time to event, y

cumulative hf rate using allhat criteria with ef 502
ALLHAT

Chlorthalidone

Doxazosin

Cumulative HF Rate Using ALLHAT Criteria; With EF<50

0.02

0.01

Cumulative ALLHAT#1 HF Rate

0.00

0

1

2

3

4

Time to event, y

cumulative hf rate using allhat criteria with ef 503
ALLHAT

Chlorthalidone

Doxazosin

Cumulative HF Rate Using ALLHAT Criteria; With EF>50

0.02

Cumulative ALLHAT#1 HF Rate

0.01

0.00

0

1

2

3

4

Time to event, y

post hf mortality with preserved systolic function ef 50
ALLHAT

Chlorthalidone

Amlodipine

Lisinopril

Post-HF Mortality With Preserved Systolic Function (EF >50)

0.80

0.70

0.60

0.50

0.40

Cumulative Post-HF Mortality Rate

0.30

0.20

0.10

0.00

0

1

2

3

4

5

6

Time to event, y

post hf mortality with impaired systolic function ef 50
ALLHAT

Chlorthalidone

Amlodipine

Lisinopril

Post-HF Mortality With Impaired Systolic Function (EF<50)

0.80

0.70

0.60

0.50

0.40

Cumulative Post-HF Mortality Rate

0.30

0.20

0.10

0.00

0

1

2

3

4

5

6

Time to event, y

post hf mortality with preserved systolic function ef 501
ALLHAT

Doxazosin

Chlorthalidone

Post-HF Mortality With Preserved Systolic Function (EF >50)

0.80

0.70

0.60

0.50

Cumulative Post HF Mortality Rate

0.40

0.30

0.20

0.10

0.00

0

1

2

3

4

Time to event, y

post hf mortality with impaired systolic function ef 501
ALLHAT

Doxazosin

Chlorthalidone

Post-HF Mortality With Impaired Systolic Function (EF<50)

0.80

0.70

0.60

0.50

Cumulative Post-HF Mortality Rate

0.40

0.30

0.20

0.10

0.00

0

1

2

3

4

Time to event, y

post hf mortality by systolic function
ALLHATPost-HF Mortality By Systolic Function

0.80

Preserved Systolic Function (EF >50)

0.70

Impaired Systolic Function (EF <50)

0.60

0.50

0.40

Cumulative ALLHAT#1 HF to Death Rate

0.30

0.20

0.10

0.00

0

1

2

3

4

5

6

Time to Event, y

slide31
HF With Preserved And Impaired Systolic Left Ventricular Function

ALLHAT

Conclusions

  • Heart Failure with preserved left ventricular systolic function is common in treated patients with hypertension (compared to heart failure with impaired systolic function).
  • Heart Failure with preserved left ventricular systolic function is associated with more edema while heart failure with impaired left ventricular systolic function is associated with signs of ventricular dilatation.
  • Heart Failure with preserved left ventricular systolic function is associated with lower case fatality (than heart failure with impaired systolic function).
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