Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Unknown |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04554160 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Rigshospitalet, Denmark |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Jørn Carlsen, MD, DMSC |
Principal Investigator Affiliation | MD at Copenhagen University Hospital, Rigshospitalet 9- Blegdamsvej |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, Industry |
Overall Status | Recruiting |
Countries | Denmark |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pulmonary Hypertension, Arrhythmias, Cardiac, Heart Rate Variability, Risk Assessment |
Contact a Trial Team
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