The Potential of Candesartan to Retard the Progression of Aortic Stenosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00699452
• Date of registration: 16/06/2008
• Prospective Registration: Yes
• Primary sponsor: Helsinki University
• Public title: The Potential of Candesartan to Retard the Progression of Aortic Stenosis ROCK-AS
• Scientific title: The Potential of Candesartan to Retard the Progression of Aortic Stenosis Influences of Medical Therapy to the Atheroinflammatory Process in Stenotic Aortic Valves
• Date of first enrolment: May 2009
• Target sample size: 120
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00699452
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Finland

Contacts

• Name: Markku Kupari, MD, PhD
• Affiliation: Division of Cardiology, Helsinki University Central Hospital

• Name: Markku Kupari, MD, PhD

• Name: Markku Kupari, MD, PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

- 120 consecutive patients with clinically significant, symptomatic aortic stenosis
referred to the Helsinki University Central Hospital for consideration of valve
replacement surgery.

Exclusion Criteria:

- 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Aortic Valve Stenosis

Intervention(s)

Drug: placebo

Drug: candesartan

Primary Outcome(s)

The degree of inflammation in stenotic aortic valves [Time Frame: 3-5 months]

Secondary Outcome(s)

The degree of calcification, lipid accumulation, and fibrosis in stenotic aortic valves [Time Frame: 3-5 months]

Secondary ID(s)

ROCK-AS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca