Intensive Vasodilator Therapy in Patients With Essential Hypertension

NCT ID: NCT01180413

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-04-30

Brief 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.

Conditions

Essential Hypertension; High Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vasodilatory

Patients in this arm will receive intensive vasodilatory treatment

Group Type: EXPERIMENTAL

Amlodipine

Intervention Type: DRUG

5 mg per day for 6 months as add-on to original ongoing antihypertensive treatment

Ramipril

Intervention Type: DRUG

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

Intervention Type: DRUG

Up to 20 mg per day for 6 months as add-on to original ongoing antihypertensive treatment

Losartan

Intervention Type: DRUG

Up to 100 mg per day for 6 months as add-on to original ongoing antihypertensive treatment

Interventions

Amlodipine

5 mg per day for 6 months as add-on to original ongoing antihypertensive treatment

Intervention Type: 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.

Intervention Type: DRUG

Lercanidipine

Up to 20 mg per day for 6 months as add-on to original ongoing antihypertensive treatment

Intervention Type: DRUG

Losartan

Up to 100 mg per day for 6 months as add-on to original ongoing antihypertensive treatment

Intervention Type: DRUG

Other Intervention Names

Amlodipin

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Morten Engholm Pedersen

MD/PhD-Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Morten Engholm Pedersen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University and Aarhus University Hospital

Ole Norling Mathiasen, MD, PhD

Role: STUDY_DIRECTOR

Aarhus University and Aarhus University Hospital

Niels Henrik Buus, DMSc

Role: STUDY_DIRECTOR

Aarhus University and Aarhus University Hospital

Ashkan Eftekhari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University and Aarhus University Hospital

Locations

Aarhus University Hospital - dept. cardiology (A)

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

26169

Identifier Type: -

Identifier Source: org_study_id