Effects of Intensive Long-Term Vasodilation in Hypertensive Patients With Microvascular Angina Pectoris
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Purpose
The purpose of this study is to determine if long-term vasodilatory treatment is more effective than the standard treatment in hypertensive patients with microvascular angina pectoris
| Condition | Intervention |
|---|---|
|
Microvascular Angina Hypertension |
Drug: Lercanidipine Drug: Valsartan Drug: Nicorandil Drug: Doxazosin Drug: Moxonidin Drug: Pindolol Drug: Amiloride, hydrochlorothiazide |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intensive Non-Sympathetic Activating Vasodilatory Treatment in Hypertensive Patients With Microvascular Angina Pectoris |
- Minimal coronary resistance [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- Peripheral vascular resistance [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- Work capacity [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- Ischemia threshold [ Time Frame: 8 months ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vasodilatory
Patients in this arm will receive intensive vasodilatory treatment to lower blood pressure
|
Drug: Lercanidipine
Individual titration, max. dose 20 mg OD for 8 months
Other Name: Zanidip
Drug: Valsartan
Individual titration, max. dose 160 mg OD for 8 months
Other Name: Diovan
Drug: Nicorandil
Individual titration, max. dose 20 mg BD for 8 months
Other Name: Angicor
Drug: Doxazosin
Individual titration, max. dose 4 mg OD for 8 months
Other Name: Doxazosin "Stada"
Drug: Moxonidin
Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 0,2 mg OD for 8 months
Other Name: Moxonidin "Alpharma"
Drug: Pindolol
Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 10 mg OD for 8 months
Other Name: Visken
Drug: Amiloride, hydrochlorothiazide
Possible add-on therapy in case target blood pressure can not be reached with a combination of the other drugs in the Vasodilatory arm. Individual titration, max. dose 1 tbl. OD for 8 months
Other Name: Sparkal
|
Detailed Description:
Patients with hypertension frequently develop angina pectoris. This can be caused by either epicardial stenotic disease or, equally frequent, by increased resistance in small resistance vessels - microvascular dysfunction. This increased resistance is caused by a process called remodelling, where the existing material in the vessel wall is rearranged around a smaller lumen, whereas the sensitivity of the smooth muscle cells to agonist stimuli is unchanged. Under resting conditions the resistance is determined by both the tone in the smooth muscle cells in the vessel walls and the structure of the vessels themselves (RREST). Under hyperemic conditions the muscles relax and the resistance is determined only by vessel structure (RMIN).
A literature survey of the various studies on this subject has shown that structural changes relates to tone rather than blood pressure. This suggests that resistance vessel structure will be normalized only by an antihypertensive treatment which normalizes RREST i.e. rely on vasodilatation as a cause of the antihypertensive effect more than reduction of cardiac output.
The main hypothesis is, that it is possible to reverse the structural changes in the resistance vessels by vasodilatory treatment for eight months, thereby achieving lower coronary and peripheral minimal resistance (as determined by MRI and plethysmography, respectively), higher work capacity on exercise-ECG and less tendency to angina in these patients.
We will include 80 patients with essential hypertension, angina pectoris CCS class II-III and signs of ischemia on exercise-ECG or myocardial SPECT, but without significant stenosis in angiography. The patients are randomised, in a parallel, open-label design, to either vasodilatory (lercanidipine, valsartan, doxazosin and nicorandil) or standard treatment (metoprolol, diltiazem and isosorbide mononitrate). The aim of treatment in both arms is BP below 120/80 and the protocol allows further add-on therapy to reach this goal. The patients will be followed for eight months with a titration period of two months. MRI, plethysmography, exercise-ECG and echocardiography will be performed before and after the study period. The primary endpoint is minimal coronary resistance as determined by MRI; secondary endpoints are peripheral vascular resistance as determined by plethysmography, work capacity and ischemia threshold on exercise-ECG or myocardial SPECT.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- hypertension
- angina pectoris CCS class II-IV
- objective signs of ischemia on exercise-ECG or myocardial SPECT
- no significant stenosis on angiography (minimal lumen diameter >50% of relevant reference segment)
Exclusion Criteria:
- known allergy to any study medication
- abnormal lab tests of clinical significance
- valvular disease of haemodynamic significance
- known secondary hypertension
- atrial fibrillation or other significant arrythmias
- myocardial infarction < 30 days before inclusion
- resting angina < one week before inclusion
- known endocrine disease, nephropathy or hepatic disease
- present malignant disease
- pregnancy
- fertile women not using safe contraceptives > 6 months before inclusion. Use of contraceptives must continue 1 month after completion or retraction from the study
- body mass index > 30
- significant chronic obstructive lung disease (FEV1 < 1.5 l)
- participant in another study including test medicine
- present treatment with dipyridamole
- present treatment with phosphodiesterase-5-inhibitors that the patient does not want to discontinue during the study period
- heart transplanted patients
- patients with magnetizable metallic implants
Contacts and Locations| Denmark | |
| Aarhus Hospital | |
| Aarhus, Denmark, 8000 | |
| Principal Investigator: | Michael N Præstholm, MD | University of Aarhus |
| Study Director: | Kent L Christensen, MD, DrMSc | Aarhus Hospital, medical-cardiologic dept. A |
| Study Director: | Won Yong Kim, MD, DrMSc | Skejby Hospital, cardiologic dept. B |
| Study Director: | Hans Erik Bøtker, MD, DrMSc | Skejby Hospital, cardiologic dept. B |
More Information
No publications provided
| Responsible Party: | Kent Lodberg Christensen, DMSc, Aarhus Hospital |
| ClinicalTrials.gov Identifier: | NCT00424801 History of Changes |
| Other Study ID Numbers: | Vasointense |
| Study First Received: | January 19, 2007 |
| Last Updated: | May 5, 2009 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Danish Medicines Agency |
Additional relevant MeSH terms:
|
Angina Pectoris Hypertension Microvascular Angina Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms Amiloride Hydrochlorothiazide Pindolol Moxonidine Nicorandil |
Doxazosin Valsartan Lercanidipine Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Antihypertensive Agents Adrenergic beta-Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013