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Table 1 Baseline Characteristics of Included RCTs

From: Pulmonary hemodynamics and effects of phosphodiesterase type 5 inhibition in heart failure: a meta-analysis of randomized trials

Study

Individuals randomized

(n; PDE5i / Placebo)

Intervention

Inclusion criteria

Entry criteria

Male (%; PDE5i / Placebo)

Age (yrs; PDE5i / Placebo)

LVEF

(%; PDE5i / Placebo)

mPAP

(mmHg; PDE5i / Placebo)

PASP

(mmHg; PDE5i / Placebo)

Follow-up duration

(months)

Outcome measures

Drug

Dosage

NYHA

LVEF

Webster LJ et al., 2004 [26]

35/35

Sildenafil

50 mg qd

CHF (HFrEF)

II–III

-

100/100

60 (total)a

26 (total)a

-

-

1.5

International Index of Erectile Function

Katz SD et al., 2005 [27]

60/72

Sildenafil

25 / 50 / 100 mg

CHF (HFrEF) with ED

I–III

≤40%

100/100

60/60

33/30

-

-

3

International Index of Erectile Function

Guazzi M et al., 2007 [6]

23/23

Sildenafil

50 mg bid

HFrEF

II–III

≤45%

100/100

62/63

30.6/31.9

-

34/32

6

CPET, EchoCG, FMD

Lewis GD et al., 2007 [5]

17/17

Sildenafil

25 to 75 mg tid

HFrEF with PH

II–IV

<40%

82/88

54/62

19/20

30/33

-

3

CPET: peak VO 2

Behling A et al., 2008

11/8

Sildenafil

50 mg tid

HFrEF

I–III

≤40%

82/50

45/53

27/39

-

56/62

1

CPET, EchoCG, FBF

Lewis GD et al., 2008 [22]

15/15

Sildenafil

25 to 75 mg tid

HFrEF with PHb

II–IV

<40%

90

58

26/28

30/33

-

3

CPET, Cardiac Cath, ventriculography

Guazzi M et al., 2011 [11]

23/22

Sildenafil

50 mg tid

HFrEF

II–III

<40%

100/100

60/61

29.5/30.2

-

37/38

12

EchoCG, CPET, BNP, QoL

Guazzi M et al., 2012 [7]

16/16

Sildenafil

50 mg tid

HFrEF with PH and EOB

III–IV

<45%

100/100

66/68

29/28

35/34

-

12

CPET, Cardiac Cath

Amin A et al., 2013 [8]

53/53

Sildenafil

25 mg bid for first 2 weeks;

50 mg tid for next 10 weeks

HFrEF

II–III

<35%

72/75

51/51

-

-

-

3

BP, NYHA, 6MWD

Kim KH et al., 2015 [9]

21/20

Udenafil

50 mg bid for first 4 weeks;

100 mg bid for next 8 weeks

HFrEF

II–IV

≤40%

76/60

62/65

30/29

-

41/43

3

EchoCG, CPET

Guazzi M et al., 2011 [12]

22/22

Sildenafil

50 mg tid

HFpEF with PH

II–IV

≥50%

77/82

72/73

60/60

39/37

55/52

12

EchoCG, Cardiac Cath, QoL

Redfield MM et al., 2013 [13]

113/103

Sildenafil

20 mg tid for first 12 weeks;

60 mg tid for next 12 weeks

HFpEF (RELAX trial)

II–IV

≥50%

57/47

68/69

60/60

-

41/41

6

EchoCG, CMRI, CPET, 6MWD

Borlaug BA et al., 2015 [14]

23/25

Sildenafil

20 mg tid for first 12 weeks;

60 mg tid for next 12 weeks

HFpEF (RELAX trial)c

II–IV

≥50%

39/44

69/71

60/60

-

28/30

6

EchoCG, CMRI, CPET, 6MWD, Radial applanation tonometry

Hoendermis ES et al., 2015 [15]

21/22

Sildenafil

20 mg tid for first 2 weeks;

60 mg tid for next 10 weeks

HFpEF with PH

II–III

≥45%

23/35

72/76

58/58

35/35

52/51

3

Cardiac Cath, CPET, EchoCG

Andersen MJ et al., 2013 [23]

35/35

Sildenafil

40 mg tid

Diastolic dysfunction after MI

-

≥45%

89/86

63/62

55/56

19/20

26/27

2

EchoCG, Cardiac cath, CPET, 6MWT

  1. Abbreviations: CHF congestive heart failure, HFrEF heart failure with reduced ejection fraction, HFpEF heart failure with preserved ejection fraction, PH pulmonary hypertension, EOB exercise oscillatory breathing, MI myocardial infarction, NYHA New York Heart Association, LVEF left ventricular ejection fraction, PDE5i phosphodiesterase type 5 inhibitor, mPAP mean pulmonary arterial pressure, PASP pulmonary artery systolic pressure, CPET cardiopulmonary exercise test, EchoCG echocardiography, FMD flow-mediated dilatation, BNP B-natriuretic peptide, QoL quality of life, BP blood pressure, 6MWD 6-min walking distance, CMR cardiac magnetic resonance
  2. a Mean of total study population
  3. b Lewis GD et al. 2008 [22] was a sub-analysis of 'Lewis GD et al. 2007 [5]'
  4. c Borlaug BA et al. 2015 [14] was a sub-analysis of 'Redfield et al. 2013 [13]', the RELAX trial