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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Essential Hypertension
High Blood Pressure
 Drug: Amlodipine
Drug: Ramipril
Drug: Lercanidipine
Drug: Losartan
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Intensive Vasodilating add-on Therapy on Peripheral Vascular Resistance and Coronary Flow Reserve in Patients With Essential Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Coronary Flow Reserve [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Determined by echocardiography


Secondary Outcome Measures:
  • 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


Enrollment: 48
Study Start Date: December 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vasodilatory
Patients in this arm will receive intensive vasodilatory treatment
 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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180413

Locations
Denmark
Aarhus University Hospital - dept. cardiology (A)
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
Investigators
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
  More Information

No publications provided

Responsible Party: Morten Engholm Pedersen, MD/PhD-Student, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01180413     History of Changes
Other Study ID Numbers: 26169
Study First Received: August 11, 2010
Last Updated: April 18, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:
Inward eutrophic remodelling

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Lercanidipine
Ramipril
Losartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013