Heart Failure Clinical Trial
— PADVaOfficial title:
Observational Study on Cardiac Morphology and Function in Patients With Peripheral Artery Disease in Vastmanland County, Sweden(PADVa).
NCT number | NCT01452165 |
Other study ID # | PADVa |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2006 |
Est. completion date | May 2011 |
Verified date | May 2020 |
Source | Uppsala University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The main purposes of this study are:
- to describe the prevalence and degree of reduced left ventricular function and
hypertrophy in patients with peripheral arterial disease in comparison to controls from
the general population,
- to evaluate factors of importance to left ventricular dysfunction and hypertrophy in
patients with peripheral arterial disease, and
- to assess the impact of cardiac function and left ventricular hypertrophy on long-term
prognosis in patients with peripheral artery disease.
Status | Completed |
Enrollment | 457 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Fulfillment of at least one of the following criteria: - ankle-brachial-index (ABI) <= 0.9, or - stenosis of > 30% of the internal carotid artery, or - symptoms typical for claudication and corresponding stenotic findings on the ultrasound examination. Exclusion Criteria: - age less than 18 years - severly impaired communication capabilities |
Country | Name | City | State |
---|---|---|---|
Sweden | Center of Clinical Research, Uppsala university, Central Hospital | Västerås |
Lead Sponsor | Collaborator |
---|---|
Uppsala University | Västmanland County Council, Sweden |
Sweden,
Hedberg P, Hammar C, Selmeryd J, Viklund J, Leppert J, Hellberg A, Henriksen E. Left ventricular systolic dysfunction in outpatients with peripheral atherosclerotic vascular disease: prevalence and association with location of arterial disease. Eur J Hear — View Citation
Hysing P, Jonason T, Leppert J, Hedberg P. Prevalence and prognostic impact of electrocardiographic abnormalities in outpatients with extracardiac artery disease. Clin Physiol Funct Imaging. 2018 Sep;38(5):823-829. doi: 10.1111/cpf.12488. Epub 2017 Nov 24 — View Citation
Nowak C, Carlsson AC, Östgren CJ, Nyström FH, Alam M, Feldreich T, Sundström J, Carrero JJ, Leppert J, Hedberg P, Henriksen E, Cordeiro AC, Giedraitis V, Lind L, Ingelsson E, Fall T, Ärnlöv J. Multiplex proteomics for prediction of major cardiovascular ev — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular ejection fraction (cross-sectional outcome measure) | LVEF obtained by echocardiographic biplane disk summation method. In the cross-sectional study, the mean value of LVEF and the prevalence of reduced LVEF (LVEF < 50%) in the patient group will be compared to the control group. | baseline | |
Primary | Cardiovascular events (longitudinal outcome measure) | Cardiovascular events obtained from the Swedish National Causes of Death register and the Swedish National In-patient register. The registers are linked to the patients by the unique personal identification number assigned to each swedish resident. | 5-10 years | |
Primary | Left ventricular mass (cross-sectional outcome measure) | Left ventricular mass obtained by 2-dimensional echocardiography according to the American Society of Echocardiography. | baseline | |
Secondary | Wall motion score index (WMSI) | Left ventricular wall motion score according to the American Society of Echocardiopgraphy. | baseline | |
Secondary | Echocardiographic left ventricular filling variables | Echocardiographic variables for evaluation of left ventricular diastolic function (e.g. E/A- and E/e'-ratios). | baseline |
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