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
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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
In general there is a lack of evidence of the arrhythmic burden in PH. The present study is
the first to apply continuous long-term cardiac monitoring in patients with PH to describe
the prevalence of arrhythmias in PH by continuous long-term cardiac monitoring. Furthermore,
the correlation between heart rate variability and risk assessment parameters including WHO
functional class (FC), NT-proBNP, 6MWT, cardiac parameters and cardiac function will be
A few prospective studies have demonstrated lower HRV in PH than in healthy individuals,
however only based on short-term monitoring (20 minutes to 24 hour) and only in a few
patients. In retrospective studies, a higher mortality in children with PAH and low HRV has
been shown with 24 hour Holter monitoring. Consequently, there is a lack of evidence
regarding right heart failure and the prognostic value of HRV.
Risk assessment in PH is essential in the selection of treatment in PH and for prognosis in
the study ASPIRE the investigators will assess the use of heart rate variability in pulmonary
In conclusion the ASPIRE study will:
1. Assess the incidence and prevalence of arrhythmias using long term cardiac monitoring
via a reveal LINQ loop recorder (Medtronic). Furthermore, the investigators will assess;
Change in cardiac index, right atrial size, RV size, fibrosis and stroke volume.
2. The investigators will assess the arrhythmic burden in relation to:
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Department of Cardiology 2141 Copenhagen University Hospital, Rigshospitalet 9- Blegdamsvej
Copenhagen, , 2100
Jørn Carlsen, MD, DMSc