CompletedNCT03370679PULSEUpdated Feb 5, 2018

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

An observational study in Premature Ventricular Complexes Multiple and Premature Ventricular Contraction, sponsored by Danderyd Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-05.

Sponsored by Danderyd Hospital · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 1,000
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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

Conditions studied

Premature Ventricular Complexes Multiple
Premature Ventricular Contraction

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Keywords

Premature
Ventricular
Complexes
Beats
Prognosis

In context

Ventricular Premature Complexes

96 studies on the registry are indexed under Ventricular Premature Complexes; 29 are open to participants now.

This study's enrollment of 1,000 is above the median of 113 across 36 observational studies indexed under Ventricular Premature Complexes.

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Lead sponsor

Danderyd Hospital is the lead sponsor of 60 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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)

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Inclusion criteria

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

Exclusion criteria

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 1,000 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

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

Secondary outcomes

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)
Time frame: Average follow-up time 3,5 years

Study locations

1 site

Hjärtkliniken Danderyds Sjukhus
Stockholm, Sweden

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03370679
Lead sponsor: Danderyd Hospital
Responsible party: Sponsor
First posted: Dec 12, 2017
Start date: Sep 2013
Primary completion: Dec 2017
Completion: Jan 2018
Last update: Feb 5, 2018

Study contacts

Raffaele Scorza, MD

principal investigator · Karolinska Institutet - Danderyd Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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