Intensive Vasodilator Therapy in Patients With Essential Hypertension
Condition: Essential Hypertension; High Blood Pressure
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether add-on of intensive vasodilator therapy can
      improve the coronary perfusion and reduce the total peripheral resistance in patients with
      ongoing treatment for essential hypertension.
    

Detailed description: 
      Morphological changes are observed in the microvasculature of patients with essential
      hypertension. The lumen diameter is reduced in resistance arteries, but with no change in
      vessel cross-sectional area or wall mass. These structural changes are termed inward
      eutrophic remodelling and results in an increased wall:lumen ratio, caused by rearrangement
      of cell matrix and not by hypertrophy of smooth muscle cells in the vascular wall as observed
      in secondary forms of hypertension. The morphological changes also occur in the coronary
      arteries and cause a reduction in the ability to increase coronary perfusion as response to
      increased cardiac work. This is observed as a reduced coronary flow reserve in patients with
      sustained hypertension.

      Two recently published clinical studies associates an increase in media:lumen ratio with an
      increased risk of cardiovascular events, and it therefore seems beneficial to normalize the
      vascular structure in patients with essential hypertension. It has previously been
      demonstrated that reversion of vascular remodelling and thereby normalization of the vascular
      structure, requires vasodilatation and not just blood pressure reduction, suggesting that
      patients with essential hypertension can benefit from antihypertensive treatment aimed to
      induce vasodilatation.

      The purpose of this study is to determine whether add-on of intensive vasodilator therapy can
      improve the coronary perfusion (coronary flow reserve) and reduce the total peripheral
      resistance in patients with ongoing treatment for essential hypertension. We also aim to
      investigate whether changes in coronary flow reserve correlates better to changes in total
      peripheral resistance than changes in blood pressure. Particularly we aim to study if
      patients with high total peripheral resistance, despite blood pressure control, can benefit
      from intensive vasodilating therapy.
    

Intervention name(s): Amlodipine; Ramipril; Lercanidipine; Losartan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5 mg per day for 6 months as add-on to original ongoing antihypertensive treatment; 5 mg per day for the first to weeks as add-on to original ongoing antihypertensive treatment. Then upward adjustment to 10 mg per day for 6 months if no intolerable side effects are experienced.; Up to 20 mg per day for 6 months as add-on to original ongoing antihypertensive treatment; Up to 100 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
Other intervention name(s): Amlodipin
Intervention MeSH terms: Losartan; Amlodipine; Ramipril; Lercanidipine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inward eutrophic remodelling