Metabolic Determinants of the Progression of Aortic Stenosis (PROGRESSA)
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| ClinicalTrials.gov Identifier: NCT01679431 |
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Recruitment Status
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Recruiting
First Posted
: September 6, 2012
Last Update Posted
: March 7, 2017
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Sponsor:
Laval University
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Philippe Pibarot, Laval University
| Tracking Information | |||||||||
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| First Submitted Date | August 24, 2012 | ||||||||
| First Posted Date | September 6, 2012 | ||||||||
| Last Update Posted Date | March 7, 2017 | ||||||||
| Study Start Date | April 2005 | ||||||||
| Estimated Primary Completion Date | January 2018 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01679431 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Outcome Measures |
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| Original Other Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Metabolic Determinants of the Progression of Aortic Stenosis | ||||||||
| 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 identifying the key metabolic determinants of AS progression and will pave the way for the future development of non surgical therapies for this disease. The results of this study would provide strong support to the realization of randomized trial to test the efficacy of lifestyle modification program or new pharmacological treatment aiming at the reduction of visceral fat and associated metabolic abnormalities in the AS population. Furthermore, this study will contribute to the identification of novel blood and imaging biomarkers of faster disease progression, which will help to optimize risk stratification and timing of AVR in the AS population. |
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| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Fasting blood sample (serum, lithium-heparin, EDTA) and white cells - Tissue (explanted aortic valves) |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Cohort will be selected at primary care clinic | ||||||||
| Condition | Aortic Valve Stenosis | ||||||||
| Intervention |
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| Study Groups/Cohorts | Patients with aortic stenosis
Patients have every year: 1) an assessment of cardiometabolic risk profile with measure of body mass index, waist circumference and fasting blood sample and 2) a comprehensive Doppler-echocardiographic exam. Computed tomography and magnetic resonance imaging are performed every 2 years. Interventions:
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
250 | ||||||||
| Original Estimated Enrollment |
300 | ||||||||
| Estimated Study Completion Date | January 2019 | ||||||||
| Estimated Primary Completion Date | January 2018 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 21 Years and older (Adult, Senior) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | Canada | ||||||||
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| Administrative Information | |||||||||
| NCT Number | NCT01679431 | ||||||||
| Other Study ID Numbers | MOP-114997 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Philippe Pibarot, Laval University | ||||||||
| Study Sponsor | Laval University | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Laval University | ||||||||
| Verification Date | March 2017 | ||||||||