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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premature Ventricular Complexes Multiple Arrhythmias, Cardiac Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Premature Ventricular Contraction Urogenital Diseases Ventricular Premature Complexes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hjärtkliniken Danderyds Sjukhus

Stockholm, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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)

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Registry information

Acronym: PULSE

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2018
First posted: Dec 12, 2017
Registry last updated: Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed