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All material available on eHealthMe. All information is observation-only, and has not been supported by scientific studies or clinical trials unless otherwise stated. Different individuals may respond to medication in different ways. Using multiple imputation to account for missing week data, the mean difference between sildenafil and placebo was 0. There were no significant differences in the clinical rank score, change in 6-minute walk distance at 24 weeks, or change in peak oxygen consumption or 6-minute walk distance at 12 weeks between treatment groups Table 3.

There were no significant differences in the components of the clinical rank score at 24 weeks or in the overall incidence of adverse, or serious adverse, events in the treatment groups. All serious adverse events exclusive of death or cardiovascular or cardiorenal hospitalization Table 3 are listed in eTable 5. There were no other notable differences in the incidence of specific serious adverse events between study groups. In paired analysis, plasma cyclic guanosine monophosphate levels increased significantly from baseline to 24 weeks in patients randomized to receive sildenafil mean increase, 8.

At CMRI, there was no difference in change in left ventricular mass or left ventricular end-diastolic volume index between treatment groups Table 4. There was also no difference in change in Doppler-assessed left ventricular diastolic function parameters or pulmonary artery systolic pressure between treatment groups. However, the change in mean arterial pressure in the entire study population was not significantly different between groups, as noted above.

More patients had missing data for aortic distensibility at 24 weeks than at baseline, but there was no difference in change in distensibility between groups. Patients treated with sildenafil had a greater increase in creatinine, cystatin C, NT-proBNP, uric acid, and endothelin-1 than patients treated with placebo, whereas changes in aldosterone and NT-procollagen III were not significantly different between groups.

Contrary to our hypothesis, long-term PDE-5 inhibition in HFPEF had no effect on maximal or submaximal exercise capacity, clinical status, quality of life, left ventricular remodeling, diastolic function parameters, or pulmonary artery systolic pressure. Renal function worsened more and NT-proBNP, endothelin-1, and uric acid levels increased more in patients treated with sildenafil. Furthermore, there were more but not significantly more patients in the sildenafil group who withdrew consent, died, or were too ill to perform the cardiopulmonary exercise test, and patients treated with sildenafil had a higher incidence of vascular adverse events.

Given the strong rationale for testing PDE-5 inhibition in HFPEF 3 and the lack of benefit observed, it is important to consider whether the study population, specifics of the therapeutic intervention, and end points were appropriate.

The clinical characteristics of patients with HFPEF enrolled in major ongoing or completed clinical trials have been summarized. Severity of heart failure in our study was also similar to or greater than other HFPEF trials, although comorbidity burden diabetes, atrial fibrillation, kidney disease may have been greater in this study population.

Concentric remodeling and hypertrophy were common but not severe, and Doppler evidence of elevated filling pressures and pulmonary hypertension were present as was neuroendocrine activation consistent with the heart failure state.

However, the characteristics of the study population were notably different from the only other study to our knowledge that evaluated the effect of PDE-5 inhibition in HFPEF. In the study by Guazzi and coauthors, 8 sildenafil had a number of beneficial effects as outlined above, although effect on exercise capacity was not tested. Importantly, in that study, patients with HFPEF had fewer comorbidities and significantly higher blood pressure, left ventricular mass, and pulmonary artery systolic pressure than the patients in the RELAX study and catheterization-documented pulmonary arterial hypertension, profound right ventricular systolic dysfunction, and right ventricular failure were present.

It may be that the primary therapeutic effects of PDE-5 inhibitors in heart failure involve the drugs' ability to dilate the pulmonary vascular bed, enhance right ventricular contractility, and reduce ventricular interdependence, 4 , 19 - 22 and that pulmonary arterial hypertension and right ventricular failure must be significant in order to observe clinical benefit in HFPEF.

Our subgroup analysis did not show any trends toward improvement in peak oxygen consumption in patients with higher pulmonary artery systolic pressure, but the presence of pulmonary arterial hypertension or right ventricular dysfunction was not assessed in this study.

Although left ventricular hypertrophy was common in participants in this study, it was far less severe than among participants in the study by Guazzi et al.

In a randomized clinical trial of PDE-5 inhibition in pulmonary arterial hypertension, the effect of sildenafil on exercise capacity was not dose related as improvement in 6-minute walk distance was seen with 20 mg 3 times daily after just 4 weeks of therapy with no further improvement with higher doses or longer duration of therapy.

For patients with heart failure and reduced ejection fraction, the benefit of PDE-5 inhibition on exercise capacity has been demonstrated acutely after a single mg dose, 25 , 26 and with 75 mg, 3 times daily for 12 weeks dose uptitrated over the course of 6 weeks. While studies in pulmonary arterial hypertension and heart failure and reduced ejection fraction have observed effects on exercise capacity with similar doses and duration of therapy, we cannot exclude the possibility that inadequate dose or duration of PDE-5 inhibition contributed to our findings.

Therapeutic sildenafil levels were associated with minimal increases in plasma cyclic guanosine monophosphate. Heart failure with preserved ejection fraction is characterized by endothelial dysfunction 27 and by lower natriuretic peptide levels than observed in heart failure and reduced ejection fraction, 28 which may suggest limited nitric oxide and natriuretic peptide activity in HFPEF.

As previously described, 3 change in peak oxygen consumption was chosen as the primary end point in the RELAX trial based on previous preclinical and clinical studies and because noncardiovascular comorbidities and motivational factors can influence measures of submaximal exercise performance in HFPEF.

Our trial was powered to detect a clinically significant difference in the change in peak oxygen consumption between groups and the estimate of variability SD, 2. The lack of treatment effect on submaximal exercise, clinical status, and physiologic end points supports the validity of the observed lack of treatment effect on maximal exercise capacity.

The high prevalence of chronotropic incompetence in the study population is noteworthy. Although numerous studies in animal models of renal dysfunction suggest that PDE-5 inhibition ameliorates progression of renal dysfunction of various etiologies, 3 , 29 - 31 in this trial, modest but statistically significant worsening of renal function was observed in patients treated with sildenafil and was associated with concordant increases in NT-proBNP, uric acid, and endothelin-1, suggesting that the decline in renal function was physiologically significant.

Studies in pulmonary arterial hypertension and erectile dysfunction have not reported worsening of renal function with PDE-5 inhibitor therapy, but little is known of the effect of PDE-5 inhibition on renal function in HFPEF. There were more but not significantly more patients who withdrew consent, died, or were too ill to perform the cardiopulmonary exercise test in the sildenafil treatment group, potentially accentuating the lack of benefit observed, particularly if those who withdrew did so due to adverse effects or poor clinical status.

A modest decrease in arterial elastance was noted in patients treated with sildenafil in the CMRI cohort. This may have been related to an effect of sildenafil on resistance that tended to decrease more in patients treated with sildenafil, but in the entire cohort, there were no differences in change in mean arterial pressure between treatment groups. The findings of this study must be interpreted in the context of other potential limitations.

Multicenter trials using peak oxygen consumption as a primary end point are challenging, but rigorous methodologies were used in the design and execution of the exercise test study protocol. The trial was not powered to address differences in clinical outcomes. Among patients with HFPEF, PDE-5 inhibition with administration of sildenafil for 24 weeks, compared with placebo, did not result in significant improvement in exercise capacity or clinical status.

Continued efforts to identify key pathophysiologic perturbations and novel therapeutic targets in HFPEF are needed. Drs Lee and Anstrom had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Analysis and interpretation of data: Drafting of the manuscript: Critical revision of the manuscript for important intellectual content: Administrative, technical, or material support: Conflict of Interest Disclosures: Dr Chen reported receiving funding for patents that his institution has licensed to Nile Therapeutics and Annexon with other patents pending at the US Patent and Trademark Office.

His institution has received a grant from Siemens. He has also given expert testimony about biomarkers in blood clotting and is the owner of Haematologic Technologies.

No other disclosures were reported. Pfizer provided study drug sildenafil and matched placebo. Role of the Sponsor: Pfizer had no role in the design and conduct of the study, collection, management, analysis, or interpretation of the data, or preparation, review, or approval of the manuscript. National Heart, Lung, and Blood Institute representatives provided advice on the trial design and appointed the protocol review committee and data and safety monitoring board.

The authors are solely responsible for the content of this article, which does not necessarily represent the official views of the National Heart, Lung, and Blood Institute or the National Institutes of Health.

We thank the patients who participated in this study, the Heart Failure Network site investigators and coordinators, the members of the Heart Failure Network data and safety monitoring board and protocol review committee, and the National Heart, Lung, and Blood Institute representatives. Flow of Patients Through the Trial. Baseline Characteristics of the Patients. Primary, Secondary, and Safety End Points. Additional Prespecified End Points.

Biomarker reference ranges eTable 3. Data are shown as median Interquartile range eTable 4. Epidemiology of diastolic heart failure. The effect of renin-angiotensin system inhibitors on mortality and heart failure hospitalization in patients with heart failure and preserved ejection fraction: Sildenafil citrate therapy for pulmonary arterial hypertension.

N Engl J Med. Sildenafil improves exercise capacity and quality of life in patients with systolic heart failure and secondary pulmonary hypertension. Phosphodiesterase 5 inhibition with sildenafil reverses exercise oscillatory breathing in chronic heart failure: Eur J Heart Fail. PDE5 inhibition with sildenafil improves left ventricular diastolic function, cardiac geometry, and clinical status in patients with stable systolic heart failure: Pulmonary hypertension in heart failure with preserved ejection fraction: Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure.

Reference equations for the six-minute walk in healthy adults. Chronotropic incompetence as a predictor of death among patients with normal electrograms taking beta blockers metoprolol or atenolol.

Enhanced external counterpulsation improves exercise tolerance in patients with chronic heart failure. J Am Coll Cardiol. Cardiac resynchronization in chronic heart failure. Recommendations for chamber quantification: J Am Soc Echocardiogr. Cardiac cycle-dependent changes in aortic area and distensibility are reduced in older patients with isolated diastolic heart failure and correlate with exercise intolerance.

Phosphodiesterase type 5 is highly expressed in the hypertrophied human right ventricle, and acute inhibition of phosphodiesterase type 5 improves contractility. Sildenafil enhances systolic adaptation, but does not prevent diastolic dysfunction, in the pressure-loaded right ventricle.

Pressure-overload magnitude-dependence of the anti-hypertrophic efficacy of PDE5A inhibition. J Mol Cell Cardiol. Chronic inhibition of cyclic GMP phosphodiesterase 5A prevents and reverses cardiac hypertrophy. Sildenafil improves exercise hemodynamics and oxygen uptake in patients with systolic heart failure.

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