Clinical Trial: Effects of Intensive Long-Term Vasodilation in Hypertensive Patients With Microvascular Angina Pectoris

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Intensive Non-Sympathetic Activating Vasodilatory Treatment in Hypertensive Patients With Microvascular Angina Pectoris

Brief Summary: The purpose of this study is to determine if long-term vasodilatory treatment is more effective than the standard treatment in hypertensive patients with microvascular angina pectoris

Detailed Summary:

Patients with hypertension frequently develop angina pectoris. This can be caused by either epicardial stenotic disease or, equally frequent, by increased resistance in small resistance vessels - microvascular dysfunction. This increased resistance is caused by a process called remodelling, where the existing material in the vessel wall is rearranged around a smaller lumen, whereas the sensitivity of the smooth muscle cells to agonist stimuli is unchanged. Under resting conditions the resistance is determined by both the tone in the smooth muscle cells in the vessel walls and the structure of the vessels themselves (RREST). Under hyperemic conditions the muscles relax and the resistance is determined only by vessel structure (RMIN).

A literature survey of the various studies on this subject has shown that structural changes relates to tone rather than blood pressure. This suggests that resistance vessel structure will be normalized only by an antihypertensive treatment which normalizes RREST i.e. rely on vasodilatation as a cause of the antihypertensive effect more than reduction of cardiac output.

The main hypothesis is, that it is possible to reverse the structural changes in the resistance vessels by vasodilatory treatment for eight months, thereby achieving lower coronary and peripheral minimal resistance (as determined by MRI and plethysmography, respectively), higher work capacity on exercise-ECG and less tendency to angina in these patients.

We will include 80 patients with essential hypertension, angina pectoris CCS class II-III and signs of ischemia on exercise-ECG or myocardial SPECT, but without significant stenosis in angiography. The patients are randomised, in a parallel, open-label design, to either vasodilatory (lercanidipine, valsartan, doxazosin and nicora
Sponsor: University of Aarhus

Current Primary Outcome: Minimal coronary resistance [ Time Frame: 8 months ]

Original Primary Outcome: Minimal coronary resistance

Current Secondary Outcome:

  • Peripheral vascular resistance [ Time Frame: 8 months ]
  • Work capacity [ Time Frame: 8 months ]
  • Ischemia threshold [ Time Frame: 8 months ]


Original Secondary Outcome:

  • Peripheral vascular resistance
  • Work capacity
  • Ischemia threshold


Information By: University of Aarhus

Dates:
Date Received: January 19, 2007
Date Started: January 2007
Date Completion: December 2008
Last Updated: May 5, 2009
Last Verified: May 2009