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The Prognostic Significance of Premature Ventricular Complexes in Patients Without Structural Heart Disease (PULSE)

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ClinicalTrials.gov Identifier: NCT03370679
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Danderyd Hospital

Brief Summary:
With this project the investigators aim to investigate whether premature ventricular complexes (PVC) have a prognostic significance in persons without structural heart disease. Further the investigators look at the possible connection between PVC-morphology and clinical outcome and investigate whether advanced cardiac imaging-methods may identify subtle signs of heart disease in PVC-patients with normal findings at echocardiography.

Condition or disease
Premature Ventricular Complexes Multiple Premature Ventricular Contraction

Detailed Description:

The PULSE project consists of four different studies:

  • in study one the investigators include patients who are evaluated because of PVCs and have no signs of structural heart disease at echocardiography and exercise test. The investigators follow them (average follow-up time 3,5 years) to investigate if they have a higher mortality och cardiovascular morbidity than standard population
  • in study two the investigators carry out a sub-group analysis of the population in study one to assess whether PVC:s different sites of origin (morphology) are related to the clinical outcome
  • in study three the investigators include persons with a high PVC-burden (at least 10 000 PVC:s/day) and normal echocardiography. The included subjects undergo magnetic resonance (MR) to investigate whether it can identify signs of heart disease where standard echocardiography cannot

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prognostic Significance of Premature Ventricular Complexes in Patients Without Structural Heart Disease
Actual Study Start Date : September 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases




Primary Outcome Measures :
  1. Mortality [ Time Frame: Average follow-up time 3,5 years ]
    Mortality compared with sex and age-matched control population. Data for Control population obtained via Socialstyrelsen (The Swedish Health Board)


Secondary Outcome Measures :
  1. Cardiovascular morbidity [ Time Frame: Average follow-up time 3,5 years ]
    Incidence of heart failure and myocardial infarction in the study population compared with age and sex-matched Controls. Control data obtained via Socialstyrelsen (The Swedish Health Board)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Premature Ventricular Complexes treated at Three major hospitals in the Stockholm area (Danderyd Hospital, Karolinska Hospital and Södersjukhuset Hospital)
Criteria

Inclusion Criteria:

- Diagnosed with Premature Ventricular Complexes at Three major Hospitals in Stockholm, Sweden

Exclusion Criteria:

  • History of Myocardial Infarction
  • Undergone coronary arterty bypass grafting (CABG)
  • Finding of Heart Failure at echocardiography
  • Direct or indirect findings of coronary ischaemia at exercise test, coronary angiography or other equivalent examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370679


Locations
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Sweden
Hjärtkliniken Danderyds Sjukhus
Stockholm, Sweden
Sponsors and Collaborators
Danderyd Hospital
Investigators
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Principal Investigator: Raffaele Scorza, MD Karolinska Institutet - Danderyd Hospital
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Responsible Party: Danderyd Hospital
ClinicalTrials.gov Identifier: NCT03370679    
Other Study ID Numbers: PULSE
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Keywords provided by Danderyd Hospital:
Premature
Ventricular
Complexes
Beats
Prognosis
Additional relevant MeSH terms:
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Premature Birth
Heart Diseases
Ventricular Premature Complexes
Cardiovascular Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes