Peripheral Vascular DiseasesPADVaNCT01452165
Peripheral Artery Disease in Vastmanland
An observational study of Peripheral Vascular Diseases and Heart Failure, run by Uppsala University at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases, Heart Failure, Ventricular Dysfunction
- How many people
- 457 participants
- Where
- 1 siteSweden
- Study dates
- May 2006to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients referred to the Ultrasound laboratory of the Vascular Surgery Department for evaluation of known or suspected vascular disease.
Who may be able to join
- 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.
Who cannot join
- age less than 18 years
- severly impaired communication capabilities
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Center of Clinical Research, Uppsala university, Central Hospital
Västerås, SE-72189
About this study
Official title: Observational Study on Cardiac Morphology and Function in Patients With Peripheral Artery Disease in Vastmanland County, Sweden(PADVa).
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.
Read the detailed 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.
- Keywords
- Cardiovascular diseases, Hypertrophy, Left ventricle, Echocardiography, Prognosis
- Medical subject headings
- Peripheral Vascular Diseases, Heart Failure, Ventricular Dysfunction, Cardiovascular Diseases, Hypertrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
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.
Measured: 5-10 years
Left ventricular mass (cross-sectional outcome measure)
Left ventricular mass obtained by 2-dimensional echocardiography according to the American Society of Echocardiography.
Measured: baseline
Secondary outcomes (2)
Wall motion score index (WMSI)
Left ventricular wall motion score according to the American Society of Echocardiopgraphy.
Measured: baseline
Echocardiographic left ventricular filling variables
Echocardiographic variables for evaluation of left ventricular diastolic function (e.g. E/A- and E/e'-ratios).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startMay 2006
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Västmanland County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Pär Hedberg, Assoc. Professor, Study chair, Center of Clinical Research, Uppsala university, Central Hospital, SE-72189 Västerås, SwedenJerzy Leppert, Senior Professor, Principal investigator, Center of Clincial Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452165
- Sponsor's protocol ID
- PADVa
- Acronym
- PADVa
- Status last verified
- May 2020
- First submitted
- 11 Oct 2011
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 Heart Fail. 2014 Jun;16(6):625-32. doi: 10.1002/ejhf.95. Epub 2014 Apr 26.
PubMed 24771615Hysing 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.
PubMed 29171136Nowak C, Carlsson AC, Ostgren CJ, Nystrom FH, Alam M, Feldreich T, Sundstrom J, Carrero JJ, Leppert J, Hedberg P, Henriksen E, Cordeiro AC, Giedraitis V, Lind L, Ingelsson E, Fall T, Arnlov J. Multiplex proteomics for prediction of major cardiovascular events in type 2 diabetes. Diabetologia. 2018 Aug;61(8):1748-1757. doi: 10.1007/s00125-018-4641-z. Epub 2018 May 24.
PubMed 29796748Dahle N, Arnlov J, Leppert J, Hedberg P. Nondipping blood pressure pattern predicts cardiovascular events and mortality in patients with atherosclerotic peripheral vascular disease. Vasc Med. 2023 Aug;28(4):274-281. doi: 10.1177/1358863X231161655. Epub 2023 Apr 10.
PubMed 37036102
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Cardiac Morphology and Function in Patients With Peripheral Artery Disease in Vastmanland County, Sweden(PADVa).
- ClinicalTrials.gov ID
- NCT01452165
- Acronym / sponsor ID
- PADVa / PADVa
- Keywords
- Cardiovascular diseases, Hypertrophy, Left ventricle, Echocardiography, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Västmanland County Council, Sweden
- Study start
- May 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred to the Ultrasound laboratory of the Vascular Surgery Department for evaluation of known or suspected vascular disease.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- age less than 18 years
- severly impaired communication capabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left ventricular ejection fraction (cross-sectional outcome measure)
Time frame: baseline
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.
Cardiovascular events (longitudinal outcome measure)
Time frame: 5-10 years
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.
Left ventricular mass (cross-sectional outcome measure)
Time frame: baseline
Left ventricular mass obtained by 2-dimensional echocardiography according to the American Society of Echocardiography.
2 secondary outcomes
Wall motion score index (WMSI)
Time frame: baseline
Echocardiographic left ventricular filling variables
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Results publication: PubMed 24771615Hedberg 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 Heart Fail. 2014 Jun;16(6):625-32. doi: 10.1002/ejhf.95. Epub 2014 Apr 26.
- Results publication: PubMed 29171136Hysing 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.
- Results publication: PubMed 29796748Nowak C, Carlsson AC, Ostgren CJ, Nystrom FH, Alam M, Feldreich T, Sundstrom J, Carrero JJ, Leppert J, Hedberg P, Henriksen E, Cordeiro AC, Giedraitis V, Lind L, Ingelsson E, Fall T, Arnlov J. Multiplex proteomics for prediction of major cardiovascular events in type 2 diabetes. Diabetologia. 2018 Aug;61(8):1748-1757. doi: 10.1007/s00125-018-4641-z. Epub 2018 May 24.
- Derived from this study: PubMed 37036102Dahle N, Arnlov J, Leppert J, Hedberg P. Nondipping blood pressure pattern predicts cardiovascular events and mortality in patients with atherosclerotic peripheral vascular disease. Vasc Med. 2023 Aug;28(4):274-281. doi: 10.1177/1358863X231161655. Epub 2023 Apr 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pär Hedberg, Assoc. Professor study chair
Center of Clinical Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden
Jerzy Leppert, Senior Professor principal investigator
Center of Clincial Research, Uppsala university, Central Hospital, SE-72189 Västerås, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Diseases and Heart Failure, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (cross-sectional outcome measure) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01452165, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020; AzTrials last refreshed its copy on 1 Nov 2026.