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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03370679

Acronym

PULSE

Enrollment

1000

Registered

2017-12-12

Start date

2013-09-30

Completion date

2018-01-31

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ventricular Complexes Multiple, Premature Ventricular Contraction

Keywords

Premature, Ventricular, Complexes, Beats, Prognosis

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mortality	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

Measure	Time frame	Description
Cardiovascular morbidity	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)

Countries

Sweden

Outcome results