Clinical Trial: Metabolic Determinants of the Progression of Aortic Stenosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Metabolic Determinants of the Progression of Aortic Stenosis - PROGRESSA Study

Brief Summary:

Calcific aortic stenosis (AS) has become the most common cardiac disease after coronary artery disease and hypertension. Unfortunately no medical therapies have been proven to decrease either the progression of valve stenosis or the resulting adverse effects on myocardial remodeling and function. In light of the studies performed in PROGRESSA, it becomes obvious that: i) AS is a complex and actively regulated process that involves the interaction of several pathways including lipid infiltration and retention, chronic inflammation, osteogenic activation, and active mineralization within the valvular tissues; ii) AS is not a disease strictly limited to the aortic valve but rather a systemic disease that often involves calcification and stiffening of the aorta and impairment of LV function as a consequence of pressure overload. Our findings suggest that the dysmetabolic milieu linked to visceral obesity may accelerate the deterioration of the structure and function not only of the aortic valve but also of the aorta and of the left ventricle. These findings open new avenues of research and provide strong impetus for the elaboration of prospective studies focusing on the "valvulo-metabolic risk" in AS.

The general hypotheses are: The metabolic abnormalities linked to visceral obesity accelerate (1) the progression of valvular calcification and stenosis, aortic calcification and stiffness; (2) the progression of myocardial fibrosis and dysfunction.

The general objectives of the study are to elucidate the mechanisms implicated in the pathogenesis of AS and to identify the metabolic factors that determine the progression of: i) aortic valve calcification and stenosis; ii) myocardial fibrosis and dysfunction; and iii) clinical outcomes.

This study will contribute to identi

Detailed Summary:
Sponsor: Laval University

Current Primary Outcome: Progression of aortic valve stenosis [ Time Frame: Patients will be followed every 1 year, up to 5 years ]

Annualized progression rate of aortic stenosis hemodynamic severity calculate as the difference between peak aortic jet velocity, transvalvular gradients, and aortic valve area measured at baseline and those measured at the last follow-up divided by the time between the first and last examinations.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression of aortic valve calcification [ Time Frame: Patients will be followed every 2 years, up to 5 years ]
    Annualized progression rate of aortic valve calcium
  • Progression of myocardial fibrosis and dysfunction [ Time Frame: PPatients will be followed every 2 years, up to 5 years ]
    Annualized progression rate of myocardial fibrosis and global longitudinal myocardial strain


Original Secondary Outcome: Same as current

Information By: Laval University

Dates:
Date Received: August 24, 2012
Date Started: April 2005
Date Completion: January 2019
Last Updated: March 6, 2017
Last Verified: March 2017