NCT00252317

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

September 3, 2008

Status Verified

November 1, 2007

First QC Date

November 10, 2005

Last Update Submit

September 2, 2008

Conditions

Aortic Stenosis

Keywords

Aortic stenosisACE-inhibitores

Outcome Measures

Primary Outcomes (1)

  • Treatment with ACE-inhibitors improves haemodynamic parameters in patients with severe aortic stenosis.

    8 weeks

Secondary Outcomes (5)

  • Treatment with ACE-inhibitors:

    8 weeks

  • Increases working capacity in patients with severe aorta stenosis.

    8 weeks

  • Improves systolic and diastolic function on left ventricle.

    8 weeks

  • In patients with severe aortic stenosis is safe.

    8 weeks

  • Degrease wall stress in left ventricle.

    8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Captopril test dose and Trandolapril

Drug: Captopril and TrandolaprilDrug: Captopril Test Dose and Trandolapril

2

PLACEBO COMPARATOR
Drug: Captopril and TrandolaprilDrug: Captopril Test Dose and Trandolapril

Interventions

Captopril and TrandolaprilDRUG

Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie. hypotension)

12
Captopril Test Dose and TrandolaprilDRUG

Caps Captopril 6.25 mg test dose and Caps Trandolapril 0.5mg or 1.0mg or 2.0 mg (depending on symptoms ie. hypotension)

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, KBH Ø, 2100, Denmark

RECRUITING

Related Publications (2)

  • 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.

    PMID: 11607794BACKGROUND

  • 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.

    PMID: 20139439DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Captopriltrandolapril

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

ProlineImino AcidsAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 11, 2005

Study Start

November 1, 2005

Study Completion

October 1, 2008

Last Updated

September 3, 2008

Record last verified: 2007-11

Locations

DK(1)