Status:
UNKNOWN
The Potential of Candesartan to Retard the Progression of Aortic Stenosis
Lead Sponsor:
University of Helsinki
Collaborating Sponsors:
AstraZeneca
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The present study defines a blinded, randomized, placebo-controlled, prospective study, the aim of which is to determine the influence of effective treatment with Type 1 angiotensin II (Ang II) recept...
Detailed Description
We will include in the study 120 consecutive patients with clinically significant, symptomatic aortic stenosis referred to the Helsinki University Central Hospital for consideration of valve replaceme...
Eligibility Criteria
Inclusion
- 120 consecutive patients with clinically significant, symptomatic aortic stenosis referred to the Helsinki University Central Hospital for consideration of valve replacement surgery.
Exclusion
- Individuals with past myocardial infarction, more than mild mitral valve disease, or previous cardiac surgery will be excluded.
- Patients with heart failure who need urgent surgery or those with hypotension (systolic blood pressure below 110 mm Hg) will be excluded.
- Patients already taking ACE inhibitors or AT-1R antagonists will be excluded from the study population.
- Other exclusion criteria include the following:
- Complicated diabetes
- Primary cardiomyopathy
- Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have a positive serum pregnancy test
- History of malignancy (unless a documented disease free period exceeding 5-years is present) with the exception of basal cell or squamous cell carcinoma of the skin. Women with a history of cervical dysplasia would be permitted to enter the study provided they had 3 consecutive clear Papanicolaou (Pap) smears
- Hypothyroidism (TSH 1.5xULN)
- History of alcohol or drug abuse within the last 5 years (this may affect compliance)
- Unexplained creatine kinase (CK 3xULN) (To protect patient safety)
- Serum creatinine \>176 umol/L (2.0mg/dL)
- Participation in another investigational drug study less than 4 weeks before enrolment in the study, or according to subjects local ethics committee requirements where a larger period is stipulated (to avoid potential misinterpretation of overlapping adverse events)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00699452
Start Date
May 1 2009
End Date
December 1 2014
Last Update
May 19 2009
Active Locations (1)
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1
Division of Cardiology, Helsinki University Central Hospital
Helsinki, Finland, 00029