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The immediate effect of sildenafil on right ventricular function in patients with heart failure measured by cardiac magnetic resonance: a randomized control trial.

Fernandes AM, Andrade AC, Barroso ND, Borges IC, Carvalho-Andrade D, Rodrigues Junior ES, Guimarães LC, Durães AR, Borges SM, Aras Junior R - PLoS ONE (2015)

Bottom Line: Except for the increase in RV fractional area change following the administration of sildenafil (Sildenafil [before vs. after]: 34.3 [25.2-43.6]% vs. 42.9 [28.5-46.7]%, p = 0.04; Placebo [before vs. after]: 28.1 [9.2-34.8]% vs. 29.2 [22.5-38.8]%, p = 0.86), there was no statistically significant change in parameters.There was no improvement in left ventricular parameters or in the fractional area change of the pulmonary artery.This study demonstrated that a single dose of Sildenafil did not significantly improve RV function as measured by the CMR.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, Hospital Ana Neri, Federal University of Bahia, Bahia, Brazil.

ABSTRACT

Background: Studies have demonstrated that phosphodiesterase 5 (PDE5) inhibition is associated with right ventricle (RV) functional improvement in patients with primary pulmonary hypertension. This study aims to demonstrate the immediate impact of Sildenafil, a PDE5 inhibitor, on RV function, measured by cardiovascular magnetic resonance (CMR), in patients with heart failure (HF).

Methods: We conducted a randomized double-blind controlled trial.

Inclusion criteria: diagnosis of HF functional class I-III; left ventricle ejection fraction < 35%. Patients underwent CMR evaluation and were then equally randomly assigned to either 50 mg of Sildenafil or Placebo groups. One hour following drug administration, they were submitted to a second scan examination.

Results: 26 patients were recruited from a tertiary reference center in Brazil and 13 were allocated to each study group. The median age was 61.5 years (50-66.5 years). Except for the increase in RV fractional area change following the administration of sildenafil (Sildenafil [before vs. after]: 34.3 [25.2-43.6]% vs. 42.9 [28.5-46.7]%, p = 0.04; Placebo [before vs. after]: 28.1 [9.2-34.8]% vs. 29.2 [22.5-38.8]%, p = 0.86), there was no statistically significant change in parameters. There was no improvement in left ventricular parameters or in the fractional area change of the pulmonary artery.

Conclusion: This study demonstrated that a single dose of Sildenafil did not significantly improve RV function as measured by the CMR.

Trial registration: ClinicalTrials.gov NCT01936350.

No MeSH data available.


Related in: MedlinePlus

Flow chart of patients who participated in the trial.MR: magnetic resonance
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pone.0119623.g001: Flow chart of patients who participated in the trial.MR: magnetic resonance

Mentions: Initially, patients from a HF outpatient service in a tertiary health care institution were screened for eligibility and a CMR exam was scheduled. Clinical data was then collected for all recruited patients, who underwent CMR evaluation without any intervention. Subsequently, the patients were equally randomly assigned to either the Sildenafil (50 mg of Sildenafil citrate) or Placebo groups and one hour following administration of the drug they were submitted to a second scan examination. This time lapse was selected because the median peak plasma serum concentration of sildenafil is 60 minutes. The simple randomization process was based on a computer-generated list of random numbers. Except for interventionists, nurses and technicians were kept blind to drug assignment (Fig. 1).


The immediate effect of sildenafil on right ventricular function in patients with heart failure measured by cardiac magnetic resonance: a randomized control trial.

Fernandes AM, Andrade AC, Barroso ND, Borges IC, Carvalho-Andrade D, Rodrigues Junior ES, Guimarães LC, Durães AR, Borges SM, Aras Junior R - PLoS ONE (2015)

Flow chart of patients who participated in the trial.MR: magnetic resonance
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4368670&req=5

pone.0119623.g001: Flow chart of patients who participated in the trial.MR: magnetic resonance
Mentions: Initially, patients from a HF outpatient service in a tertiary health care institution were screened for eligibility and a CMR exam was scheduled. Clinical data was then collected for all recruited patients, who underwent CMR evaluation without any intervention. Subsequently, the patients were equally randomly assigned to either the Sildenafil (50 mg of Sildenafil citrate) or Placebo groups and one hour following administration of the drug they were submitted to a second scan examination. This time lapse was selected because the median peak plasma serum concentration of sildenafil is 60 minutes. The simple randomization process was based on a computer-generated list of random numbers. Except for interventionists, nurses and technicians were kept blind to drug assignment (Fig. 1).

Bottom Line: Except for the increase in RV fractional area change following the administration of sildenafil (Sildenafil [before vs. after]: 34.3 [25.2-43.6]% vs. 42.9 [28.5-46.7]%, p = 0.04; Placebo [before vs. after]: 28.1 [9.2-34.8]% vs. 29.2 [22.5-38.8]%, p = 0.86), there was no statistically significant change in parameters.There was no improvement in left ventricular parameters or in the fractional area change of the pulmonary artery.This study demonstrated that a single dose of Sildenafil did not significantly improve RV function as measured by the CMR.

View Article: PubMed Central - PubMed

Affiliation: Department of Cardiology, Hospital Ana Neri, Federal University of Bahia, Bahia, Brazil.

ABSTRACT

Background: Studies have demonstrated that phosphodiesterase 5 (PDE5) inhibition is associated with right ventricle (RV) functional improvement in patients with primary pulmonary hypertension. This study aims to demonstrate the immediate impact of Sildenafil, a PDE5 inhibitor, on RV function, measured by cardiovascular magnetic resonance (CMR), in patients with heart failure (HF).

Methods: We conducted a randomized double-blind controlled trial.

Inclusion criteria: diagnosis of HF functional class I-III; left ventricle ejection fraction < 35%. Patients underwent CMR evaluation and were then equally randomly assigned to either 50 mg of Sildenafil or Placebo groups. One hour following drug administration, they were submitted to a second scan examination.

Results: 26 patients were recruited from a tertiary reference center in Brazil and 13 were allocated to each study group. The median age was 61.5 years (50-66.5 years). Except for the increase in RV fractional area change following the administration of sildenafil (Sildenafil [before vs. after]: 34.3 [25.2-43.6]% vs. 42.9 [28.5-46.7]%, p = 0.04; Placebo [before vs. after]: 28.1 [9.2-34.8]% vs. 29.2 [22.5-38.8]%, p = 0.86), there was no statistically significant change in parameters. There was no improvement in left ventricular parameters or in the fractional area change of the pulmonary artery.

Conclusion: This study demonstrated that a single dose of Sildenafil did not significantly improve RV function as measured by the CMR.

Trial registration: ClinicalTrials.gov NCT01936350.

No MeSH data available.


Related in: MedlinePlus