Intensive Vasodilator Therapy in Patients With Essential Hypertension (Vasomore)
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|ClinicalTrials.gov Identifier: NCT01180413|
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : April 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Essential Hypertension High Blood Pressure||Drug: Amlodipine Drug: Ramipril Drug: Lercanidipine Drug: Losartan||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Intensive Vasodilating add-on Therapy on Peripheral Vascular Resistance and Coronary Flow Reserve in Patients With Essential Hypertension|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Patients in this arm will receive intensive vasodilatory treatment
5 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
Other Name: Amlodipin
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
- Coronary Flow Reserve [ Time Frame: 6 months ]Determined by echocardiography
- Puls Wave Velocity [ Time Frame: 6 months ]
- Left ventricular mass [ Time Frame: 6 months ]Determined with echocardiography
- Blood Pressure [ Time Frame: 6 months ]Ambulatory Blood Pressure
- Peripheral Vascular Resistance [ Time Frame: 6 months ]By Innocor
- Minimal forearm vascular resistance [ Time Frame: 6 months ]By pletysmography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180413
|Aarhus University Hospital - dept. cardiology (A)|
|Aarhus, Denmark, 8000|
|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|