Clinical Trial: Atorvastatin in Pulmonary Hypertension

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Effect and Tolerability of Atorvastatin Versus Placebo in Patients With Pulmonary Hypertension: Double-blinded, Randomised, Prospective Phase II Study for 6 Month

Brief Summary: Clinical effect and tolerability of atorvastatin versus placebo in patients with Pulmonary Hypertension: double-blinded, randomised, prospective phase II study for 6 months with adjusted doses of Atorvastatin

Detailed Summary:

PAH is characterized by dyspnea, fatigue, and lower extremity edema as a result of heart failure. Several research have proved that inflammation may participate in the pathogenesis of PAH. As atorvastatin inhibits inflammation and has beneficial effects on blood vessels in other types of cardiovascular disease. Therefore, atorvastatin may similarly benefit patients with PAH. Experimental data suggest that statins attenuates pulmonary hypertension in animal experiments. In addition, non-controlled clinical studies suggest that atorvastatin is effective and safe in patients with pulmonary hypertension.

Participants in this study will be randomly assigned to receive 6 months of daily placebo tablets or daily atorvastatin in a double-blind fashion. The study will compare the safety and efficacy of placebo and atorvastatin.


Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Current Primary Outcome: The placebo-corrected change from baseline to week 24 in 6-minute walk distance [ Time Frame: Measured at 6 months ]

Original Primary Outcome: Distance walked in six minutes [ Time Frame: Measured at 6 months ]

Current Secondary Outcome:

  • Time from randomization to clinical worsening [ Time Frame: Measured at 6 months ]
    Clinical worsening was defined as death, the first occurrence of hospitalization for pulmonary arterial hypertension, or initiation of PAH-specific drug therapy
  • Change from baseline to week 24 in World Health Organization functional class [ Time Frame: measured at 6 monthes ]
    World Health Organization (WHO) functional class: an adaptation of the New York Heart Association classification.
  • Change from baseline to week 24 in Borg dyspnea score [ Time Frame: measured at 6 monthes ]
    Borg dyspnea score: with 0 representing no dyspnea and 10 maximal dyspnea.
  • Change from baseline to week 24 in hemodynamic parameters derived from right heart catheterization. [ Time Frame: measured at 6 monthes ]
    Hemodynamic parameters: mean pulmonary artery pressure, right atrial pressure, cardiac index and pulmonary vascular resistance.


Original Secondary Outcome:

  • mean pulmonary arterial pressure [ Time Frame: Measured at 6 months ]
  • cardiac index [ Time Frame: measured at 6 monthes ]
  • heart rate [ Time Frame: measured at 6 monthes ]
  • blood pressure [ Time Frame: measured at 6 monthes ]
  • Borg scale [ Time Frame: measured at 6 monthes ]
  • Time to clinical events [ Time Frame: measured at 6 monthes ]


Information By: Chinese Academy of Medical Sciences, Fuwai Hospital

Dates:
Date Received: February 4, 2008
Date Started: February 2007
Date Completion:
Last Updated: February 22, 2012
Last Verified: February 2012