What is the clinical evidence from this study?

Study design: RCT. Population: Persistent pulmonary hypertension after correction of valvular heart disease (n=200). Intervention: Sildenafil vs. Placebo. Primary outcome: Composite clinical score combining death, hospital admission for heart failure, change in functional class, and patient global self-assessment (OR 0.39, 95% CI 0.22-0.67, p=<0.001).

What does this research mean for the field?

Treatment with sildenafil in patients with persistent pulmonary hypertension after successfully corrected valvular heart disease results in worse clinical outcomes compared to placebo. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

August 16, 2026European Heart JournalOpen Access

Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial

Q: What are the key findings of this study?

Sildenafil treatment for 6 months in patients with persistent pulmonary hypertension after corrected valvular heart disease resulted in worse composite clinical scores compared to placebo (OR for improvement 0.39).

Q: What does this research mean for the field?

Treatment with sildenafil in patients with persistent pulmonary hypertension after successfully corrected valvular heart disease results in worse clinical outcomes compared to placebo. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

Q: What question did this study set out to answer?

To determine whether treatment with sildenafil improves clinical outcomes in patients with persistent pulmonary hypertension following successful heart valve replacement or repair.

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Key result

Sildenafil worsens clinical outcomes vs placebo in persistent pulmonary hypertension after valve surgery.

OR 0.39
95% CI 0.22-0.67
P<0.001
n=200

Why the study?

It was unknown whether treatment with sildenafil improves outcomes in patients with persistent pulmonary hypertension after correction of valvular heart disease.

Does sildenafil improve the composite clinical score in adults with persistent pulmonary hypertension after successful correction of valvular heart disease?

Key Points

To determine whether treatment with sildenafil improves clinical outcomes in patients with persistent pulmonary hypertension following successful heart valve replacement or repair.
Multicenter, double-blind, randomized, parallel, placebo-controlled trial (N=200; NCT00862043) in stable adults with mean pulmonary artery pressure ≥ 30 mmHg who underwent successful valve repair or replacement ≥ 1 year prior.
Patients were randomized to receive oral sildenafil (40 mg three times daily, n = 104) or placebo (n = 96) for 6 months.
Fewer patients receiving sildenafil improved their composite clinical score compared with placebo (27 vs. 44), while more worsened (33 vs. 14; odds ratio 0.39, 95% CI 0.22–0.67, P < 0.001).
Six-month survival without heart failure admission was 0.76 in the sildenafil group versus 0.86 in the placebo group (hazard ratio 2.0, 95% CI = 1.0–4.0; log-rank P = 0.044), with 31 versus 22 heart failure hospital admissions (OR 0.43, 95% CI 0.20–0.94; P = 0.035).
Changes in 6-minute walk test distance, natriuretic peptides, and Doppler-derived systolic pulmonary pressure were similar between groups.

Study Design

Type

RCT (n=200)

Blinding

Double-blind

Randomization

Randomly permuted blocks of size four

Multicenter

Yes

Structured PICO

Does sildenafil improve the composite clinical score in adults with persistent pulmonary hypertension after successful correction of valvular heart disease?

Population

200 stable adults (median age 72, 77% female) with persistent pulmonary hypertension at least 1 year after successful correction of valvular heart disease, followed for 6 months.

Intervention

Sildenafil 40 mg oral three times daily (or 20 mg three times daily for low BMI/hypotension) for 6 months.

Comparator

Matching placebo for 6 months.

Outcome

Composite clinical score at 6 months combining death, hospital admission for heart failure requiring intravenous diuretic treatment, change in WHO functional class, and patient global self-assessment.composite

Main Result

Odds Ratio: 0.39 (95% CI 0.22–0.67)

Absolute Event Rate: 26% vs 45.8%

p-value: p=<0.001

Limitations

The study group was heterogeneous in terms of VHD primary lesions, but sample size did not allow for detailed subgroup comparisons.
The study was underpowered to obtain significant results in most of the secondary endpoints.
The composite clinical score merges outcomes of diverse significance and may seem subjective.
Small sample size limited interaction analyses

Discussion

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Key expert perspectives

Captured external expert commentary on this paper, strongest first. Original sources are linked where available.

JB Javier BermejoCardiologist, Gregorio Marañón University Hospital, Madrid

“Compared to patients taking placebo, the chance for worse clinical outcomes – as defined by the combined clinical score – was more than twice as high in those taking sildenafil. We were unable to identify any particular subset of patients who could potentially benefit from sildenafil.”

Hospital General Universitario Gregorio MarañónConference Coverage

IM Irene M. LangProfessor of vascular biology, Medical University of Vienna

“a very clear study”

Medical University of ViennaConference Coverage

JB Javier BermejoCardiologist, Gregorio Marañón University Hospital, Madrid

“We believe based upon our results that off-label use of sildenafil in patients with left heart disease-pulmonary hypertension due to valvular disease should be discouraged.”

Hospital General Universitario Gregorio MarañónConference Coverage

Implication

Avoid sildenafil in persistent PH after valve correction; challenges assumptions favoring PDE5 inhibition in this setting.

Cite This Study

Bermejo et al. (2017) conducted an RCT in Persistent pulmonary hypertension after correction of valvular heart disease (n=200). Sildenafil vs. Placebo was evaluated on Composite clinical score combining death, hospital admission for heart failure, change in functional class, and patient global self-assessment (OR 0.39, 95% CI 0.22-0.67, p=<0.001). Sildenafil treatment for 6 months in patients with persistent pulmonary hypertension after corrected valvular heart disease resulted in worse composite clinical scores compared to placebo (OR for improvement 0.39).

synapsesocial.com/papers/6a824be8ccba119b6216fa6d https://doi.org/10.1093/eurheartj/ehx700

Topics

Valvular heart disease HFrEF treatment Heart failure

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Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Key expert perspectives

Implication

Cite This Study

Topics

Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial

Key Points

Study Design

Structured PICO

Main Result

Limitations

Discussion

Key expert perspectives

Implication

Cite This Study

Also Consider

Topics

Also Consider