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Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring

NCT04554160 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-04-10

No results posted yet for this study

Summary

Arrhythmias are considered a prominent phenomenon in pulmonary hypertension (PH) as the disease progresses. According primarily to retrospective studies with up to 24 hours of monitoring, supraventricular tachycardias (SVT) can be found in 8-35% of patients, with significant impact on survival.

Furthermore, a few prospective studies to date deploying short-term monitoring (10 minutes-24 hours) have revealed lower heart rate variability (HRV) in patients with pulmonary arterial hypertension (PAH).

In ASPIRE arrhythmias and heart rate variability is being assessed via long term monitoring.

Currently the the loop-recorder is considered the gold standard for long-term continuous cardiac montoring. A non-invasive continuous monitoring could be of a great benefit for the patients, and could potentially contribute to treatment optimization.

The study will assess apple watches as a non-invasive tool compared to to the loop recorder, which is considered as the current gold standard.

Additionally, the study seeks to assess apple watches for monitoring as an independent wearable for risk assessment in PH.

Conditions

  • Pulmonary Hypertension
  • Arrhythmias, Cardiac
  • Heart Rate Variability
  • Risk Assessment

Interventions

DEVICE

Loop recorder implantation

A loop recorder is implanted in the start of the study after informed consent is signed and enables continuous cardiac monitoring.

DEVICE

A smartwatch

A subgroup of the patients will be given an apple watch after informed consent to enables continuous monitoring via this non-invasive modality.

Sponsors & Collaborators

  • Actelion

    collaborator INDUSTRY

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Jørn Carlsen, MD, DMSC · MD at Copenhagen University Hospital, Rigshospitalet 9- Blegdamsvej

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2024-11-01
Completion
2024-11-01
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04554160 on ClinicalTrials.gov