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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
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00252317
First received: November 10, 2005
Last updated: September 2, 2008
Last verified: November 2007
History of Changes
  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 4

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:

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)

  Show Detailed Description

  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:

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

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 May 22, 2013