NCT05496504

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

2.3 years

First QC Date

August 9, 2022

Last Update Submit

June 10, 2023

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertensionPHarrhythmiassurvival

Outcome Measures

Primary Outcomes (1)

  • Arrhythmias during Holter ECG

    Which kind of arrhythmias could be detected during repetitive Holter ECG in patients with PH?

    1-3 day(s)

Secondary Outcomes (1)

  • Relation between arrhythmias and PH group, echocardiographic data, right heart catheterization data.

    1-3 day(s)

Interventions

Holter ECGOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with PH of all groups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension, PulmonaryArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 11, 2022

Study Start

September 1, 2013

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share