Pulmonary Hypertension Clinical Trial
— ASPIREOfficial title:
ArrhythmiaS in Pulmonary arterIal hypeRtEnsion and Right Heart Failure Assessed by Continuous Long-term Cardiac Monitoring
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | November 1, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pulmonary hypertension patients >18 years of age - Voluntary participation after giving informed verbal and written consent - Patients naïve to PAH-specific treatments - Patients on current PAH specific medication independent of duration of therapy - Patients can be in WHO group 1 classified by one of the following subgroups: - Idiopathic pulmonary arterial hypertension (IPAH) - Heritable pulmonary arterial hypertension (HPAH) - Drugs and toxins - Associated with (APAH): specifically, connective tissue disease (CTD), HIV infection and congenital heart disease - Patients with chronic thromboembolic pulmonary hypertension - Diagnosis of PAH confirmed by right heart catheterization - WHO/NYHA functional class II to IV symptoms - 6MWT distances of =50 meters and within 15% of each other on 2 consecutive tests preferably performed on different days during Screening. Exclusion Criteria: - Presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction at Screening: BMI >30 kg/m2; diabetes mellitus of any type; systemic hypertension, significant coronary artery disease; or left atrial volume index (LAVi) >30 mL/m2. - Evidence or history of left-sided heart disease and/or clinically significant cardiac disease. - Acutely decompensated heart failure within 30 days prior to Screening - Evidence of significant parenchymal lung disease - Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (SBP) >160 mmHg or sitting diastolic blood pressure (DBP) >100 mmHg at Screening. • Systolic blood pressure >160 mmHg or < 90 mmHg; or diastolic blood pressure > 100 mgHg at Screening - Male subjects with a corrected QT interval using Fridericia's formula (QTcF) >450 msec, and female subjects with QTcF >470 msec on ECG measured at Screening or Baseline. - Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Cardiology 2141 Copenhagen University Hospital, Rigshospitalet 9- Blegdamsvej | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Actelion |
Denmark,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Arrhythmias and their impact on death or transplantation | Do any patients die because of the arrhythmias and will any patients need a transplantation because of terminal PH and arrhythmias. | 2022 | |
Other | Arrhythmias impact on specific PAH therapy | How many patients will need escalation in PAH therapy when having arrhythmia and how much of an increase. | 2022 | |
Other | Arrhythmias impact on six minute walking tests | Arrhythmias impact on reduction in number of meters performed in a six minute walking test during the study period. | 2022 | |
Other | Arrhythmias and their impact on NT-proBNP | NT-proBNP change during the study period. | 2022 | |
Primary | The incidence and prevalence of arrhythmias in pulmonary hypertension | Assessed throughout continuous cardiac monitoring | 2022 | |
Primary | Heart rate variability | Throughout continuous cardiac monitoring heart rate variability will be assessed as a clinical marker. It will be compared with already known clinical markers in pulmonary hypertension and compared with echocardiography and cardiac MR scans. | 2023 | |
Primary | Arrhythmias and their impact on heart function assessed with echocardiography | Change in function of the right and left heart chambers in the patients' with and without arrhythmias assessed with echocardiography. | 2022 | |
Primary | Heart rate variability and heart function assessed with CMR scans. | The patients' heart rate variability will be compared to the function of the right and left ventricle (LVEF, RVEF) | 2022 | |
Primary | Heart rate variability and chamber sizes assessed CMR scans | The patients' heart rate variability will be compared to the size of the right and left ventricle (ml) | 2023 | |
Primary | Change in heart function when having arrhythmias, assessed with CMR scans. | The patients' arrhythmic burden will be compared to the function of the right and left ventricle (LVEF, RVEF) | 2023 | |
Primary | Heart size in the group with and without arrhythmias, assessed with CMR scans. | The patients' arrhythmic burden will be compared to the size of the right and left ventricle (ml). | 2023 | |
Primary | Chamber sizes in patients with and without arrhythmias assessed with echocardiography. | Change in echocardiography parameters assess by the size of the right and left heart chambers (ml and cm2) in the patients with and without arrhythmias. | 2023 | |
Primary | The association between variables recorded via the apple watch and current risk assessment parameters in PH | Association models between the variables in order to assess the apple watch applicability for risk assessment. | 2024 | |
Secondary | Arrhythmias and their impact on WHO functional class | Modified WHO functional class when having arrhythmias | 2022 |
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