Essential HypertensionPhase 4VasomoreNCT01180413
Intensive Vasodilator Therapy in Patients With Essential Hypertension
A Phase 4 study testing Amlodipine, Ramipril and Lercanidipine in people with Essential Hypertension and High Blood Pressure, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Essential Hypertension, High Blood Pressure
- What is being tested?
- Amlodipine, Ramipril and Lercanidipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2010to Apr 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ongoing antihypertensive treatment for >3 months
- Blood pressure >120/75 during antihypertensive treatment
- Ejection fraction > 45%
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Amlodipine, Ramipril, Lercanidipine, Losartan
- Keywords
- Inward eutrophic remodelling
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Also called Amlodipin
5 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
RamiprilDrug
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.
LercanidipineDrug
Up to 20 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
LosartanDrug
Up to 100 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
| Study group | Role | What they receive |
|---|---|---|
| Vasodilatory | Experimental | Patients in this arm will receive intensive vasodilatory treatment Receives: Drug: Amlodipine; Drug: Ramipril; Drug: Lercanidipine; Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Flow Reserve
Determined by echocardiography
Measured: 6 months
Secondary outcomes (5)
Puls Wave Velocity
Measured: 6 months
Left ventricular mass
Determined with echocardiography
Measured: 6 months
Blood Pressure
Ambulatory Blood Pressure
Measured: 6 months
Peripheral Vascular Resistance
By Innocor
Measured: 6 months
Minimal forearm vascular resistance
By pletysmography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Morten Engholm Pedersen, Aarhus University Hospital
- Investigators
- Morten Engholm Pedersen, MD, Principal investigator, Aarhus University and Aarhus University HospitalOle Norling Mathiasen, MD, PhD, Study director, Aarhus University and Aarhus University HospitalNiels Henrik Buus, DMSc, Study director, Aarhus University and Aarhus University HospitalAshkan Eftekhari, MD, PhD, Principal investigator, Aarhus University and Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180413
- Sponsor's protocol ID
- 26169
- Acronym
- Vasomore
- Status last verified
- Apr 2012
- First submitted
- 11 Aug 2010
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Vasodilating add-on Therapy on Peripheral Vascular Resistance and Coronary Flow Reserve in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01180413
- Acronym / sponsor ID
- Vasomore / 26169
- Conditions
- Essential Hypertension, High Blood Pressure
- Keywords
- Inward eutrophic remodelling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Dec 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 12 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vasodilatory | Experimental | Drug: Amlodipine, Drug: Ramipril, Drug: Lercanidipine, Drug: LosartanPatients in this arm will receive intensive vasodilatory treatment |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ongoing antihypertensive treatment for >3 months
- Blood pressure >120/75 during antihypertensive treatment
- Ejection fraction > 45%
Key exclusion criteria (12 listed)
- Blood pressure >160/100
- Pregnancy
- fertile women not using safe contraceptives
- known secondary hypertension
- valvular disease of haemodynamic significance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmlodipineAlso: Amlodipin5 mg per day for 6 months as add-on to original ongoing antihypertensive treatment | Drug | Vasodilatory |
| Ramipril5 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. | Drug | Vasodilatory |
| LercanidipineUp to 20 mg per day for 6 months as add-on to original ongoing antihypertensive treatment | Drug | Vasodilatory |
| LosartanUp to 100 mg per day for 6 months as add-on to original ongoing antihypertensive treatment | Drug | Vasodilatory |
Primary outcome
Coronary Flow Reserve
Time frame: 6 months
Determined by echocardiography
5 secondary outcomes
Puls Wave Velocity
Time frame: 6 months
Left ventricular mass
Time frame: 6 months
Blood Pressure
Time frame: 6 months
Peripheral Vascular Resistance
Time frame: 6 months
Minimal forearm vascular resistance
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Engholm Pedersen, MD principal investigator
Aarhus University and Aarhus University Hospital
Ole Norling Mathiasen, MD, PhD study director
Aarhus University and Aarhus University Hospital
Niels Henrik Buus, DMSc study director
Aarhus University and Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine, Ramipril and Lercanidipine in people with Essential Hypertension and High Blood Pressure, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary Flow Reserve (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2012.