Heart failure with preserved and impaired systolic left ventricular function in allhat
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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

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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

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

Randomized 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)


ALLHAT

Rationale 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


ALLHAT

Heart 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.


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.


ALLHAT

HF 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.


ALLHAT

45%

EF>50%

EF<50%

N=928

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

HF With Preserved And Impaired Systolic Left Ventricular Function


ALLHAT

HF With Preserved And Impaired Systolic Left Ventricular Function

EF>50%

EF N/A

EF 40-49%

EF<40%

N=1399

HF by EF level


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


ALLHAT

HF With Preserved And Impaired Systolic Left Ventricular Function


ALLHAT

HF With Preserved And Impaired Systolic Left Ventricular Function


ALLHAT

HF With Preserved And Impaired Systolic Left Ventricular Function


HF With Preserved And Impaired Systolic Left Ventricular Function

ALLHAT


HF With Preserved And Impaired Systolic Left Ventricular Function

ALLHAT


HF With Preserved And Impaired Systolic Left Ventricular Function

ALLHAT

EF Range by Drug

*lisinopril vs. chlorthalidone p=0.04


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


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)


HF With Preserved And Impaired Systolic Left Ventricular Function

ALLHAT

Vital Status by Drug and EF Group


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


ALLHAT

Cumulative 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


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


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


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


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


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


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


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


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


ALLHAT

Post-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


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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