Intensive Vasodilator Therapy in Patients With Essential Hypertension (Vasomore)

This study has been completed.
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Morten Engholm Pedersen, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01180413
First received: August 11, 2010
Last updated: April 18, 2012
Last verified: April 2012

August 11, 2010
April 18, 2012
December 2010
April 2012   (final data collection date for primary outcome measure)
Coronary Flow Reserve [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Determined by echocardiography
Same as current
Complete list of historical versions of study NCT01180413 on ClinicalTrials.gov Archive Site
  • Puls Wave Velocity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Left ventricular mass [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determined with echocardiography
  • Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Ambulatory Blood Pressure
  • Peripheral Vascular Resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    By Innocor
  • Minimal forearm vascular resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    By pletysmography
Same as current
Not Provided
Not Provided
 
Intensive Vasodilator Therapy in Patients With Essential Hypertension
Effects of Intensive Vasodilating add-on Therapy on Peripheral Vascular Resistance and Coronary Flow Reserve in Patients With Essential Hypertension

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Essential Hypertension
  • High Blood Pressure
  • Drug: Amlodipine
    5 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
    Other Name: Amlodipin
  • Drug: Ramipril
    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.
    Other Name: Ramipril
  • Drug: Lercanidipine
    Up to 20 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
    Other Name: Lercanidipine
  • Drug: Losartan
    Up to 100 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
    Other Name: Losartan
Experimental: Vasodilatory
Patients in this arm will receive intensive vasodilatory treatment
Interventions:
  • Drug: Amlodipine
  • Drug: Ramipril
  • Drug: Lercanidipine
  • Drug: Losartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ongoing antihypertensive treatment for >3 months
  • Blood pressure >120/75 during antihypertensive treatment
  • Ejection fraction > 45%

Exclusion Criteria:

  • Blood pressure >160/100
  • Pregnancy
  • fertile women not using safe contraceptives
  • known secondary hypertension
  • valvular disease of haemodynamic significance
  • known endocrine disease, nephropathy or hepatic disease
  • present malignant disease
  • known psychiatric disease
  • abnormal lab tests of clinical significance
  • known allergy to any study medication
  • body mass index > 35
  • Ongoing antihypertensive treatment with a combination of ACE-inhibitor and Calcium antagonist.
Both
25 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01180413
26169
Yes
Morten Engholm Pedersen, Aarhus University Hospital
Aarhus University Hospital
University of Aarhus
Principal Investigator: Morten Engholm Pedersen, MD Aarhus University and Aarhus University Hospital
Study Director: Ole Norling Mathiasen, MD, PhD Aarhus University and Aarhus University Hospital
Study Director: Niels Henrik Buus, DMSc Aarhus University and Aarhus University Hospital
Principal Investigator: Ashkan Eftekhari, MD, PhD Aarhus University and Aarhus University Hospital
Aarhus University Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP