Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study)

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks
Sildenafil	sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks

Participant Flow:   Overall Study

	Placebo	Sildenafil
STARTED	103	113
COMPLETED	98	101
NOT COMPLETED	5	12

1.  Primary:

Exercise Capacity, as Determined by Peak Oxygen Uptake   [ Time Frame: Change from Baseline to Week 24 ]

2.  Secondary:

Exercise Capacity, as Determined by Peak Oxygen Uptake   [ Time Frame: Change from Baseline to Week 12 ]

3.  Secondary:

Exercise Capacity as Determined by Walk Distance   [ Time Frame: Change from Baseline to Week 12 ]

4.  Secondary:

Composite Score Reflective of Clinical Status   [ Time Frame: Measured at Week 24 ]

5.  Secondary:

Exercise Capacity as Determined by Walk Distance   [ Time Frame: Change from Baseline to Week 24 ]

6.  Secondary:

Cardiopulmonary Exercise Test (CPET) Duration   [ Time Frame: Change from Baseline to Week 12 ]

7.  Secondary:

Cardiopulmonary Exercise Test (CPET) Duration   [ Time Frame: Change from Baseline to Week 24 ]

8.  Secondary:

Ventilatory Anaerobic Threshold   [ Time Frame: Change from Baseline to Week 12 ]

9.  Secondary:

Ventilatory Anaerobic Threshold   [ Time Frame: Change from Baseline to Week 24 ]

10.  Secondary:

Minnesota Living With Heart Failure Questionnaire (MLWHFQ)   [ Time Frame: Change from Baseline to Week 12 ]

11.  Secondary:

Minnesota Living With Heart Failure Questionnaire   [ Time Frame: Change from Baseline to Week 24 ]

12.  Other Pre-specified:

MRI Left Ventricular Mass   [ Time Frame: Change from Baseline to Week 24 ]

13.  Other Pre-specified:

MRI Left Ventricular Mass Index   [ Time Frame: Change from Baseline to Week 24 ]

14.  Other Pre-specified:

MRI Left Ventricular End Diastolic Volume   [ Time Frame: Change from Baseline to Week 24 ]

15.  Other Pre-specified:

MRI Left Ventricular End Diastolic Volume Index   [ Time Frame: Change from Baseline to Week 24 ]

16.  Other Pre-specified:

MRI Left Ventricular End Systolic Volume Index   [ Time Frame: Change from Baseline to Week 24 ]

17.  Other Pre-specified:

MRI Left Ventricular Ejection Fraction (LVEF)   [ Time Frame: Change from Baseline to Week 24 ]

18.  Other Pre-specified:

Echocardiogram Left Ventricular Mass   [ Time Frame: Change from Baseline to Week 24 ]

19.  Other Pre-specified:

Medial Diastolic Elastance   [ Time Frame: Change from Baseline to Week 24 ]

20.  Other Pre-specified:

Lateral Diastolic Elastance   [ Time Frame: Change from Baseline to Week 24 ]

21.  Other Pre-specified:

Medial Left Ventricular Relaxation   [ Time Frame: Change from Baseline to Week 24 ]

22.  Other Pre-specified:

Lateral Left Ventricular Relaxation   [ Time Frame: Change from Baseline to Week 24 ]

23.  Other Pre-specified:

Medial Filling Pressure   [ Time Frame: Change from Baseline to Week 24 ]

24.  Other Pre-specified:

Lateral Filling Pressure   [ Time Frame: Change from Baseline to Week 24 ]

25.  Other Pre-specified:

ECHO Effective Arterial Elastance   [ Time Frame: Change from Baseline to Week 24 ]

26.  Other Pre-specified:

ECHO Systemic Vascular Resistance   [ Time Frame: Change from Baseline to Week 24 ]

27.  Other Pre-specified:

MRI Effective Arterial Elastance   [ Time Frame: Change from Baseline to Week 24 ]

28.  Other Pre-specified:

MRI Systemic Vascular Resistance   [ Time Frame: Change from Baseline to Week 24 ]

29.  Other Pre-specified:

MRI Aortic Thickness   [ Time Frame: Change from Baseline to Week 24 ]

30.  Other Pre-specified:

MRI Aortic Distensibility   [ Time Frame: Change from Baseline to Week 24 ]

31.  Other Pre-specified:

ECHO Pulmonary Artery Systolic Pressure   [ Time Frame: Change from Baseline to Week 24 ]

32.  Other Pre-specified:

Best Available Creatinine   [ Time Frame: Change from Baseline to Week 24 ]

33.  Other Pre-specified:

Best Available Glomerular Filtration Rate (GFR)   [ Time Frame: Change from Baseline to Week 24 ]

34.  Other Pre-specified:

Cystatin C   [ Time Frame: Change from Baseline to Week 24 ]

35.  Other Pre-specified:

Uric Acid   [ Time Frame: Change from Baseline to Week 24 ]

36.  Other Pre-specified:

N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)   [ Time Frame: Change from Baseline to Week 24 ]

37.  Other Pre-specified:

Aldosterone   [ Time Frame: Change from Baseline to Week 24 ]

38.  Other Pre-specified:

High Sensitivity Troponin I   [ Time Frame: Change from Baseline to Week 24 ]

39.  Other Pre-specified:

Procollagen III N-terminal Peptide   [ Time Frame: Change from Baseline to Week 24 ]

40.  Other Pre-specified:

Endothelin-1   [ Time Frame: Change from Baseline to Week 24 ]

41.  Other Pre-specified:

High Sensitivity C-Reactive Protein   [ Time Frame: Change from Baseline to Week 24 ]

42.  Other Pre-specified:

Collagen Type I (CITP)   [ Time Frame: Change from Baseline to Week 24 ]

43.  Other Pre-specified:

Cyclic Guanosine Monophosphate (cGMP)   [ Time Frame: Change from Baseline to Week 24 ]

44.  Other Pre-specified:

Galectin 3   [ Time Frame: Change from Baseline to Week 24 ]

45.  Other Pre-specified:

Furosemide-Equivalent Dose   [ Time Frame: Change from Baseline to Week 24 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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