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

Completed

• Conditions: Premature Ventricular Complexes Multiple; Premature Ventricular Contraction

• Registration Number: NCT03370679
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2017-11-30
• Primary Completion: 2017-12
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-12
• Study Completion: 2018-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Hjärtkliniken Danderyds Sjukhus; 🇸🇪 Stockholm, Sweden