- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00252317
Acute Haemodynamic Effects of Treatment With Angiotensin Converting Enzyme (ACE)-Inhibitors in Patients With Symptomatic Aortic Stenosis
Acute Haemodynamic Effects of Treatment With ACE-Inhibitors in Patients With Symptomatic Aortic Stenosis (ACCESS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 :
- Invasive measured haemodynamic parameters (Swann-Ganz)
- Working capacity
- Diastolic and systolic function (measured with tissue Doppler echocardiography)
- Blood pressure
- B-type natriuretic peptide (BNP)
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Kbh Ø
-
Copenhagen, Kbh Ø, Denmark, 2100
- Recruiting
- Rigshospitalet, Copenhagen University Hospital
-
Contact:
- Morten Dalsgaard, MD
- Phone Number: +45 35 45 06 29
- Email: md@dadlnet.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Valvular aortic stenosis with a aortic valve area < 1, 0 cm2
- Age > 18 years
- Willingness to give written informed consent
For patients with symptomatic aortic stenosis at least one of following:
- Stable angina pectoris
- Syncope at exertion
- Dizziness at exertion
- Previous pulmonary oedema
- Patients in New York Heart Association functional class II-IV
Exclusion Criteria:
- Sitting systolic pressure < 100 mmHg
- Creatinine > 200 mM at screening
- Renal artery stenosis
- Pregnancy or planned pregnancy
- Participation in other studies
- Any patient characteristic that may interfere with compliance with the study protocol
- Treated with ACE-inhibitor or angiotensin receptor blocker within the last month
- Known allergy to ACE-inhibitors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie.
hypotension)
Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie.
hypotension)
|
Active Comparator: 1
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)
Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie.
hypotension)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment with ACE-inhibitors improves haemodynamic parameters in patients with severe aortic stenosis.
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment with ACE-inhibitors:
Time Frame: 8 weeks
|
8 weeks
|
Increases working capacity in patients with severe aorta stenosis.
Time Frame: 8 weeks
|
8 weeks
|
Improves systolic and diastolic function on left ventricle.
Time Frame: 8 weeks
|
8 weeks
|
In patients with severe aortic stenosis is safe.
Time Frame: 8 weeks
|
8 weeks
|
Degrease wall stress in left ventricle.
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Publications and helpful links
General Publications
- Routledge HC, Townend JN. ACE inhibition in aortic stenosis: dangerous medicine or golden opportunity? J Hum Hypertens. 2001 Oct;15(10):659-67. doi: 10.1038/sj.jhh.1001260.
- Dalsgaard M, Kjaergaard J, Pecini R, Iversen KK, Kober L, Moller JE, Grande P, Clemmensen P, Hassager C. Predictors of exercise capacity and symptoms in severe aortic stenosis. Eur J Echocardiogr. 2010 Jul;11(6):482-7. doi: 10.1093/ejechocard/jeq002. Epub 2010 Feb 6.
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Pathological Conditions, Anatomical
- Aortic Valve Disease
- Heart Valve Diseases
- Ventricular Outflow Obstruction
- Aortic Valve Stenosis
- Constriction, Pathologic
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Angiotensin-Converting Enzyme Inhibitors
- Trandolapril
- Captopril
Other Study ID Numbers
- 3D
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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