Chronic Inhibition of cGMP phosphodiesterase 5A improves diabetic cardiomyopathy: a randomized, controlled clinical trial using magnetic resonance imaging with myocardial tagging

Circulation. 2012 May 15;125(19):2323-33. doi: 10.1161/CIRCULATIONAHA.111.063412. Epub 2012 Apr 11.

Abstract

Background: cGMP phosphodiesterase type 5 protein is upregulated in myocardial hypertrophy. However, it has never been ascertained whether phosphodiesterase type 5 inhibition exerts an antiremodeling effect in nonischemic heart disease in humans. We explored the cardioreparative properties of a selective phosphodiesterase type 5 inhibitor, sildenafil, in a model of diabetic cardiomyopathy.

Methods and results: Fifty-nine diabetic men (60.3 ± 7.4 years) with cardiac magnetic resonance imaging consistent with nonischemic, nonfailing diabetic cardiomyopathy (reduced circumferential strain [σ], -12.6 ± 3.1; increased left ventricular [LV] torsion [θ], 18.4 ± 4.6°; and increased ratio of LV mass to volume, 2.1 ± 0.5 g/mL) were randomized to receive sildenafil or placebo (100 mg/d). At baseline, the metabolic indices were correlated with torsion, strain, N-terminal pro-B-type natriuretic peptide, vascular endothelial growth factor, monocyte chemotactic protein-1, and blood pressure. After 3 months, sildenafil produced a significant improvement compared with placebo in LV torsion (Δθ: sildenafil, -3.89 ± 3.11° versus placebo, 2.13 ± 2.35°; P<0.001) and strain (Δσ: sildenafil, -3.30 ± 1.86 versus placebo, 1.22 ± 1.84; P<0.001). Sildenafil-induced improvement of LV contraction was accompanied by consistent changes in chamber geometry and performance, with a 6.5 ± 11 improvement in mass-to-volume ratio over placebo (P=0.021). Monocyte chemotactic protein-1 and transforming growth factor-β were the only markers affected by active treatment (Δmonocyte chemotactic protein-1: -75.30 ± 159.28 pg/mL, P=0.032; Δtransforming growth factor-β: 5.26 ± 9.67 ng/mL, P=0.009). No changes were found in endothelial function, afterload, or metabolism.

Conclusions: The early features of diabetic cardiomyopathy are LV concentric hypertrophy associated with altered myocardial contraction dynamics. Chronic phosphodiesterase type 5 inhibition, at this stage, has an antiremodeling effect, resulting in improved cardiac kinetics and circulating markers. This effect is independent of any other vasodilatory or endothelial effects and is apparently exerted through a direct intramyocardial action.

Trial registration: ClinicalTrials.gov NCT00692237.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Cardiac Imaging Techniques / methods
  • Cyclic Nucleotide Phosphodiesterases, Type 5 / metabolism*
  • Diabetes Mellitus, Type 2 / complications
  • Diabetic Cardiomyopathies / drug therapy*
  • Diabetic Cardiomyopathies / pathology*
  • Follow-Up Studies
  • Humans
  • Hypertrophy, Left Ventricular / drug therapy
  • Hypertrophy, Left Ventricular / pathology
  • Magnetic Resonance Imaging / methods*
  • Male
  • Middle Aged
  • Phosphodiesterase 5 Inhibitors / administration & dosage*
  • Phosphodiesterase 5 Inhibitors / adverse effects
  • Piperazines / administration & dosage*
  • Piperazines / adverse effects
  • Purines / administration & dosage
  • Purines / adverse effects
  • Sildenafil Citrate
  • Sulfones / administration & dosage*
  • Sulfones / adverse effects
  • Torsion, Mechanical
  • Treatment Outcome
  • Ventricular Remodeling / drug effects

Substances

  • Phosphodiesterase 5 Inhibitors
  • Piperazines
  • Purines
  • Sulfones
  • Sildenafil Citrate
  • Cyclic Nucleotide Phosphodiesterases, Type 5
  • PDE5A protein, human

Associated data

  • ClinicalTrials.gov/NCT00692237