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Sponsored by: |
Rigshospitalet, Denmark |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00252317 |
Abundant evidence suggests that Angiotensin Converting Enzyme (ACE) inhibition potentially could reduce the hazardous effects of aortic stenosis and improve haemodynamics. The treatment seems safe even in patients with severe stenosis. There are however no randomised clinical trials that can confirm this hypothesis.
Condition | Intervention | Phase |
---|---|---|
Aortic Stenosis |
Drug: Captopril and Trandolapril Drug: Captopril Test Dose and Trandolapril |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Acute Haemodynamic Effects of Treatment With ACE-Inhibitors in Patients With Symptomatic Aortic Stenosis (ACCESS) |
Estimated Enrollment: | 64 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
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1: Active Comparator
Captopril test dose and Trandolapril
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Drug: Captopril and Trandolapril
Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie. hypotension)
Drug: Captopril Test Dose and Trandolapril
Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie. hypotension)
|
2: Placebo Comparator |
Drug: Captopril and Trandolapril
Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie. hypotension)
Drug: Captopril Test Dose and Trandolapril
Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie. hypotension)
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Traditionally vasodilators are contraindicated in patients with aortic stenosis. Although no controlled data exists it is believed to be hazardous to reduce afterload, including treatment with angiotensin converting enzyme (ACE) inhibitors, in these patients with aortic stenosis due to the risk of increased transaortic gradient and thus severe hypotension and myocardial hypoperfusion. There is now growing evidence both experimental and clinical that ACE inhibition could have beneficial effects on left ventricular hypertrophy, diastolic function, acute, and possibly chronic haemodynamic parameters in patients with aortic stenosis.
There is, however, a lack of clinical randomized trials that could confirm these findings.
Aims
Prospective double blinded randomised study investigating the safety and effects of treatment with ACE-inhibitor in patients with severe aortic stenosis. Effects will be measured on :
Patients
32 patients with symptomatic aorta stenosis recruited from Rigshospitalet department of cardiology. Patients referred for evaluation prior to surgical intervention with insertion of a valvular prosthesis will be screened.
Additional 32 patients with asymptomatic aorta stenosis will be recruited from Rigshospitalet and other cardiology departments.
Methods
Recruitment
Patients with symptomatic severe aortic stenosis scheduled for aortic valve replacement at The Heart Centre at Rigshospitalets department of cardiology will be recruited.
Patients with severe asymptomatic aortic stenosis on Rigshospitalet will be recruited. If it is necessary, patients from other hospitals will be recruited.
Randomisation
After baseline screening, patients will be randomized to active treatment or placebo. Half of the patients will have ACE-inhibitors (Captopril-test dose after this Trandolapril) the other half placebo.
Administration of medicine
ACE-inhibitor/placebo administration will be double blinded and performed by a hospital pharmacist not involved in any other part of the project.
All patients will be hospitalised in the intensive care unit for the first 3 days to evaluate the acute haemodynamic changes when they start the treatment. If the patients have no symptoms after the 3 days they will discharge for further treatment for up to 8 weeks. Visits are planned after 2 and 8 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For patients with symptomatic aortic stenosis at least one of following:
Exclusion Criteria:
Denmark, KBH Ø | |
Rigshospitalet, Copenhagen University Hospital | Recruiting |
Copenhagen, KBH Ø, Denmark, 2100 | |
Contact: Morten Dalsgaard, MD +45 35 45 06 29 md@dadlnet.dk |
Principal Investigator: | Morten Dalsgaard, MD | Rigshospitalet, Denmark |
Principal Investigator: | Christian Hassager, MD, Phd | Rigshospitalet, Denmark |
Principal Investigator: | Peter Clemmensen, MD, Phd | Rigshospitalet, Denmark |
Principal Investigator: | Peer Grande, MD, Phd | Rigshospitalet, Denmark |
Study ID Numbers: | 3d |
Study First Received: | November 10, 2005 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00252317 |
Health Authority: | Denmark: Danish Medicines Agency |
Aortic stenosis ACE-inhibitores |
Pathological Conditions, Anatomical Captopril Trandolapril Heart Diseases |
Constriction, Pathologic Aortic valve stenosis Aortic Valve Stenosis Heart Valve Diseases |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors Ventricular Outflow Obstruction |