Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity

NCT02241109 | Completed

• 1 other identifier: 087/14
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Aortic stenosis is the most common valvular heart disease and an important public-health problem. Surgical or interventional aortic valve replacement are based on symptoms and measures of valvular and ventricular function using echocardiography.There is no uniform pattern of progression. Instead, marked differences not only between individuals, but also during the time course of the disease can be observed. Several prospective studies have been performed to enhance the predictability of disease behavior. Individually it is still prone to large errors and hard to predict aortic stenosis progression. Therefore, in patients with aortic sclerosis without severe stenosis, it is desirable to find a strong predictor of rapid disease progression. This would allow anticipating cardiovascular deterioration by identifying individuals at particular risk. Study Hypothesis In patients with aortic sclerosis, increased serum calcification propensity, as measured by the T50-Test, is related to the amount of stenosis progression in one year.

Conditions

Aortic Valve Sclerosis; Aortic Valve Stenosis; Stenosis Progression; Valvular Heart Disease

Keywords

aortic stenosis progression; aortic valve sclerosis progression; calcification propensity

Outcome Measures

Primary Outcomes (1)

• Progression of peak aortic jet velocity over one year (m/s per year)

  One year

Secondary Outcomes (2)

• Progression of peak aortic jet velocity >20% in one year

  One year

• Combined endpoint: death, hospitalizations, aortic-valve replacement, heart failure, angina, syncope

  One year

Study Arms (1)

All patients

OTHER

Compare patients with high calcification propensity do have faster valve-stenosis progression

Other: no intervention

Interventions

no intervention OTHER

progression monitoring by echocardiography

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient referred to routine clinical echocardiography
• Aortic sclerosis with or without stenosis
• Written informed consent

You may not qualify if:

• Age \<18 years
• Any aortic valvular disease other than degenerative sclerotic, bi- or unicuspid valves
• Known disease with expected survival \<1 year
• Known malignant tumor
• Subvalvular obstruction (in left ventricular outflow tract) with mean pressure gradient \>10mmHg

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Cardiology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (8)

• Otto CM, Lind BK, Kitzman DW, Gersh BJ, Siscovick DS. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999 Jul 15;341(3):142-7. doi: 10.1056/NEJM199907153410302.

  PMID: 10403851 BACKGROUND

• Manning WJ. Asymptomatic aortic stenosis in the elderly: a clinical review. JAMA. 2013 Oct 9;310(14):1490-7. doi: 10.1001/jama.2013.279194.

  PMID: 24104373 BACKGROUND

• Freeman RV, Otto CM. Spectrum of calcific aortic valve disease: pathogenesis, disease progression, and treatment strategies. Circulation. 2005 Jun 21;111(24):3316-26. doi: 10.1161/CIRCULATIONAHA.104.486738. No abstract available.

  PMID: 15967862 BACKGROUND

• Otto CM, Burwash IG, Legget ME, Munt BI, Fujioka M, Healy NL, Kraft CD, Miyake-Hull CY, Schwaegler RG. Prospective study of asymptomatic valvular aortic stenosis. Clinical, echocardiographic, and exercise predictors of outcome. Circulation. 1997 May 6;95(9):2262-70. doi: 10.1161/01.cir.95.9.2262.

  PMID: 9142003 BACKGROUND

• Koos R, Brandenburg V, Mahnken AH, Muhlenbruch G, Stanzel S, Gunther RW, Floege J, Jahnen-Dechent W, Kelm M, Kuhl HP. Association of fetuin-A levels with the progression of aortic valve calcification in non-dialyzed patients. Eur Heart J. 2009 Aug;30(16):2054-61. doi: 10.1093/eurheartj/ehp158. Epub 2009 May 8.

  PMID: 19429630 BACKGROUND

• Pasch A, Farese S, Graber S, Wald J, Richtering W, Floege J, Jahnen-Dechent W. Nanoparticle-based test measures overall propensity for calcification in serum. J Am Soc Nephrol. 2012 Oct;23(10):1744-52. doi: 10.1681/ASN.2012030240. Epub 2012 Sep 6.

  PMID: 22956818 BACKGROUND

• Smith ER, Ford ML, Tomlinson LA, Bodenham E, McMahon LP, Farese S, Rajkumar C, Holt SG, Pasch A. Serum calcification propensity predicts all-cause mortality in predialysis CKD. J Am Soc Nephrol. 2014 Feb;25(2):339-48. doi: 10.1681/ASN.2013060635. Epub 2013 Oct 31.

  PMID: 24179171 BACKGROUND

• Rosenhek R, Klaar U, Schemper M, Scholten C, Heger M, Gabriel H, Binder T, Maurer G, Baumgartner H. Mild and moderate aortic stenosis. Natural history and risk stratification by echocardiography. Eur Heart J. 2004 Feb;25(3):199-205. doi: 10.1016/j.ehj.2003.12.002.

  PMID: 14972419 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Stefano de Marchi, Senior Consultant

  Dept. of Cardiology, University Hospital Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 16, 2014
• Study Start: September 30, 2014
• Primary Completion: January 31, 2016
• Study Completion: February 28, 2017
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

CH (1)