- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05496504
Pulmonary Hypertension and Arrhythmia
June 10, 2023 updated by: Asklepios Neurological Clinic Bad Salzhausen
Incidence and Prognostic Significance of (Malignant) Arrhythmias During Repetitive Holter Electrocardiograms in Patients With Pulmonary Hypertension
Patients with pulmonary hypertension underwent (routine) Holter ECG and were screened for (malignant) arrhyhtmias.
Results of Holter ECGs were correlated with clinicial and technical data (echocardiography and right heart catheterization).
Study Overview
Study Type
Observational
Enrollment (Actual)
222
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with PH of all groups
Description
Inclusion Criteria: Holter ECG -
Exclusion Criteria: None
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arrhythmias during Holter ECG
Time Frame: 1-3 day(s)
|
Which kind of arrhythmias could be detected during repetitive Holter ECG in patients with PH?
|
1-3 day(s)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relation between arrhythmias and PH group, echocardiographic data, right heart catheterization data.
Time Frame: 1-3 day(s)
|
1-3 day(s)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2013
Primary Completion (Actual)
December 31, 2015
Study Completion (Actual)
December 31, 2015
Study Registration Dates
First Submitted
August 9, 2022
First Submitted That Met QC Criteria
August 9, 2022
First Posted (Actual)
August 11, 2022
Study Record Updates
Last Update Posted (Estimated)
June 13, 2023
Last Update Submitted That Met QC Criteria
June 10, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PH09_08_2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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