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

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ClinicalTrials.gov Identifier: NCT00252317
Recruitment Status : Unknown
Verified November 2007 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : November 11, 2005
Last Update Posted : September 3, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Aortic Stenosis Drug: Captopril and Trandolapril Drug: Captopril Test Dose and Trandolapril Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Haemodynamic Effects of Treatment With ACE-Inhibitors in Patients With Symptomatic Aortic Stenosis (ACCESS)
Study Start Date : November 2005
Estimated Study Completion Date : October 2008


Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

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

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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00252317     History of Changes
Other Study ID Numbers: 3d
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: September 3, 2008
Last Verified: November 2007

Keywords provided by Rigshospitalet, Denmark:
Aortic stenosis
ACE-inhibitores

Additional relevant MeSH terms:
Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Captopril
Trandolapril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents