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

Premature Ventricular Contraction Clinical Trial

— PULSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370679
• Other study ID #: PULSE
• Status: Completed
• Phase: N/A
• First received: November 30, 2017
• Last updated: February 1, 2018
• Start date: September 2013
• Est. completion date: January 2018

Study information

• Verified date: February 2018
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Premature Birth
• Premature Ventricular Complexes Multiple
• Premature Ventricular Contraction
• Ventricular Premature Complexes

Locations

Country	Name	City	State
Sweden	Hjärtkliniken Danderyds Sjukhus	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality compared with sex and age-matched control population. Data for Control population obtained via Socialstyrelsen (The Swedish Health Board)	Average follow-up time 3,5 years
Secondary	Cardiovascular morbidity	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)	Average follow-up time 3,5 years