Acute Haemodynamic Effects of Treatment With Angiotensin Converting Enzyme (ACE)-Inhibitors in Patients With Symptomatic Aortic Stenosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2007 by Rigshospitalet, Denmark. Recruitment status was Recruiting

First Received on November 10, 2005. Last Updated on September 2, 2008 History of Changes

Sponsor:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00252317

Purpose

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Acute Haemodynamic Effects of Treatment With ACE-Inhibitors in Patients With Symptomatic Aortic Stenosis (ACCESS)

Resource links provided by NLM:

Drug Information available for: Captopril Trandolapril

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Treatment with ACE-inhibitors improves haemodynamic parameters in patients with severe aortic stenosis. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

Treatment with ACE-inhibitors: [ Time Frame: 8 weeks ]
Increases working capacity in patients with severe aorta stenosis. [ Time Frame: 8 weeks ]
Improves systolic and diastolic function on left ventricle. [ Time Frame: 8 weeks ]
In patients with severe aortic stenosis is safe. [ Time Frame: 8 weeks ]
Degrease wall stress in left ventricle. [ Time Frame: 8 weeks ]

Estimated Enrollment:	64
Study Start Date:	November 2005
Estimated Study Completion Date:	October 2008

Arms	Assigned Interventions
Active Comparator: 1 Captopril test dose and Trandolapril	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)
Placebo Comparator: 2	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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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252317

Locations

Denmark
Rigshospitalet, Copenhagen University Hospital	Recruiting
Copenhagen, Kbh Ø, Denmark, 2100
Contact: Morten Dalsgaard, MD +45 35 45 06 29 md@dadlnet.dk

Sponsors and Collaborators

Rigshospitalet, Denmark

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

More Information

Publications:

Routledge HC, Townend JN. ACE inhibition in aortic stenosis: dangerous medicine or golden opportunity? J Hum Hypertens. 2001 Oct;15(10):659-67. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Feb 6.

ClinicalTrials.gov Identifier:	NCT00252317 History of Changes
Other Study ID Numbers:	3d
Study First Received:	November 10, 2005
Last Updated:	September 2, 2008
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:

Aortic stenosis
ACE-inhibitores

Additional relevant MeSH terms:

Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical
Angiotensin-Converting Enzyme Inhibitors
Captopril

Trandolapril
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012