Peripheral Artery Disease in Vastmanland

Heart Failure Clinical Trial

— PADVa  

Official title:

Observational Study on Cardiac Morphology and Function in Patients With Peripheral Artery Disease in Vastmanland County, Sweden(PADVa).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452165
• Other study ID #: PADVa
• Status: Completed
• Start date: May 2006
• Est. completion date: May 2011

Study information

• Verified date: May 2020
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Left ventricular dysfunction is often a consequence of coronary heart disease (CHD). CHD is prevalent among patients with peripheral artery disease. However, there is limited data regarding left ventricular morphology and function in those patients. In the cross-sectional part of this study we will describe the prevalence of reduced cardiac function and left ventricular hypertrophy in a cohort of patients with peripheral artery disease. The patient outcomes will be compared to control subjects randomly selected from the general population in a case-control design. Further, clinical and genetic determinants of cardiac dysfunction in the patient cohort will be identified. In the longitudinal part of the study, the impact of cardiac function and morphology on cardiovascular mortality and morbidity will be evaluated in the cohort.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Heart Failure
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases
• Ventricular Dysfunction

Locations

Country	Name	City	State
Sweden	Center of Clinical Research, Uppsala university, Central Hospital	Västerås

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Västmanland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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

Outcome

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