Intensive Vasodilator Therapy in Patients With Essential Hypertension

Essential Hypertension Clinical Trial

— Vasomore  

Official title:

Effects of Intensive Vasodilating add-on Therapy on Peripheral Vascular Resistance and Coronary Flow Reserve in Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180413
• Other study ID #: 26169
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2010
• Last updated: April 18, 2012
• Start date: December 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• High Blood Pressure
• Hypertension

Intervention

Drug:
• Amlodipine
5 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
• 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.
• Lercanidipine
Up to 20 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
• Losartan
Up to 100 mg per day for 6 months as add-on to original ongoing antihypertensive treatment

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital - dept. cardiology (A)	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Flow Reserve	Determined by echocardiography	6 months	No
Secondary	Puls Wave Velocity		6 months	No
Secondary	Left ventricular mass	Determined with echocardiography	6 months	No
Secondary	Blood Pressure	Ambulatory Blood Pressure	6 months	No
Secondary	Peripheral Vascular Resistance	By Innocor	6 months	No
Secondary	Minimal forearm vascular resistance	By pletysmography	6 months	No