Pulmonary HypertensionASPIRENCT04554160
Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
An observational study of Pulmonary Hypertension and Arrhythmias, Cardiac, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Arrhythmias, Cardiac, Heart Rate Variability
- What is being tested?
- Loop recorder implantation and A smartwatch
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Sep 2018to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with pulmonary hypertension: 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
Who may be able to join
- 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)
Show all 13Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Cardiology 2141 Copenhagen University Hospital, Rigshospitalet 9- Blegdamsvej
Copenhagen, 2100
Jørn Carlsen, MD, DMSc, (+45) 35458060, joern.carlsen@regionh.dk
About this study
Official 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).
Read more
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.
Read the detailed description
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 studies.
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 hypertension.
In conclusion the ASPIRE study will:
- 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.
- The investigators will assess the arrhythmic burden in relation to:
- Change in 6 MWT
- Hemodynamic changes with RHC
- Hemodynamic changes in echocardiography
- The number of patients progressing one FC (Modified NYHA class)
- Changes in NT-proBNP.
- Hospital admission for any reason
- Death or transplantation
- Monitor heart rate variability and address a comparison to known risk markers and CMR and echocardiography. The study specifically seeks to investigate following:
- The incidence and type of supraventricular and ventricular arrhythmias in PH by continuous long-term monitoring
- The predictive value of both right and left ventricular cardiac magnetic resonance (CMR) imaging parameters for arrhythmogenesis in PAH, heart rate variability, and heart rate.
- Optimization of specific therapy in PAH using continuous long-term arrhythmia monitoring
- Monitor patients using smart watches (apple watches) to evaluate the applicability of long-term monitoring via apple watches in patients with pulmonary hypertension for irsk asessment.
- Being tested
- Loop recorder implantation, A smartwatch
- Keywords
- arrhythmias, Heart rate variability, Pulmonary Hypertension, Risk assessment, Continuous heart monitoring via wearables
- Medical subject headings
- Hypertension, Pulmonary, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loop recorder implantationDevice
Also called Reveal LINQ loop recorder
A loop recorder is implanted in the start of the study after informed consent is signed and enables continuous cardiac monitoring.
A smartwatchDevice
Also called Apple watch
A subgroup of the patients will be given an apple watch after informed consent to enables continuous monitoring via this non-invasive modality.
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and prevalence of arrhythmias in pulmonary hypertension
Assessed throughout continuous cardiac monitoring
Measured: 2022
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.
Measured: 2023
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.
Measured: 2022
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)
Measured: 2022
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)
Measured: 2023
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)
Measured: 2023
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).
Measured: 2023
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.
Measured: 2023
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.
Measured: 2024
Secondary outcomes (1)
Arrhythmias and their impact on WHO functional class
Modified WHO functional class when having arrhythmias
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start24 Sep 2018
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Actelion
- Responsible party
- Principal investigator, Jørn Carlsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jørn Carlsen, MD, DMSC, Study director, MD at Copenhagen University Hospital, Rigshospitalet 9- Blegdamsvej
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554160
- Sponsor's protocol ID
- H-18005164
- Acronym
- ASPIRE
- Status last verified
- Nov 2023
- First submitted
- 26 Aug 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hoeper MM, Bogaard HJ, Condliffe R, Frantz R, Khanna D, Kurzyna M, Langleben D, Manes A, Satoh T, Torres F, Wilkins MR, Badesch DB. Definitions and diagnosis of pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D42-50. doi: 10.1016/j.jacc.2013.10.032.
PubMed 24355641Tongers J, Schwerdtfeger B, Klein G, Kempf T, Schaefer A, Knapp JM, Niehaus M, Korte T, Hoeper MM. Incidence and clinical relevance of supraventricular tachyarrhythmias in pulmonary hypertension. Am Heart J. 2007 Jan;153(1):127-32. doi: 10.1016/j.ahj.2006.09.008.
PubMed 17174650Wen L, Sun ML, An P, Jiang X, Sun K, Zheng L, Liu QQ, Wang L, Zhao QH, He J, Jing ZC. Frequency of supraventricular arrhythmias in patients with idiopathic pulmonary arterial hypertension. Am J Cardiol. 2014 Nov 1;114(9):1420-5. doi: 10.1016/j.amjcard.2014.07.079. Epub 2014 Aug 13.
PubMed 25217453Olsson KM, Nickel NP, Tongers J, Hoeper MM. Atrial flutter and fibrillation in patients with pulmonary hypertension. Int J Cardiol. 2013 Sep 1;167(5):2300-5. doi: 10.1016/j.ijcard.2012.06.024. Epub 2012 Jun 22.
PubMed 22727973Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
PubMed 26320113Wanamaker B, Cascino T, McLaughlin V, Oral H, Latchamsetty R, Siontis KC. Atrial Arrhythmias in Pulmonary Hypertension: Pathogenesis, Prognosis and Management. Arrhythm Electrophysiol Rev. 2018 Mar;7(1):43-48. doi: 10.15420/aer.2018.3.2.
PubMed 29636972Mercurio V, Peloquin G, Bourji KI, Diab N, Sato T, Enobun B, Housten-Harris T, Damico R, Kolb TM, Mathai SC, Tedford RJ, Tocchetti CG, Hassoun PM. Pulmonary arterial hypertension and atrial arrhythmias: incidence, risk factors, and clinical impact. Pulm Circ. 2018 Apr-Jun;8(2):2045894018769874. doi: 10.1177/2045894018769874. Epub 2018 Mar 26.
PubMed 29575972Cannillo M, Grosso Marra W, Gili S, D'Ascenzo F, Morello M, Mercante L, Mistretta E, Salera D, Zema D, Bissolino A, Fusaro E, Marra S, Libertucci D, Gaita F. Supraventricular Arrhythmias in Patients With Pulmonary Arterial Hypertension. Am J Cardiol. 2015 Dec 15;116(12):1883-9. doi: 10.1016/j.amjcard.2015.09.039. Epub 2015 Oct 9.
PubMed 26522342Cirulis MM, Ryan JJ, Archer SL. Pathophysiology, incidence, management, and consequences of cardiac arrhythmia in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Pulm Circ. 2019 Jan-Mar;9(1):2045894019834890. doi: 10.1177/2045894019834890.
PubMed 30747032Rajdev A, Garan H, Biviano A. Arrhythmias in pulmonary arterial hypertension. Prog Cardiovasc Dis. 2012 Sep-Oct;55(2):180-6. doi: 10.1016/j.pcad.2012.06.002.
PubMed 23009914Folino AF, Bobbo F, Schiraldi C, Tona F, Romano S, Buja G, Bellotto F. Ventricular arrhythmias and autonomic profile in patients with primary pulmonary hypertension. Lung. 2003 Nov-Dec;181(6):321-8. doi: 10.1007/s00408-003-1034-x.
PubMed 14749936da Silva Goncalves Bos D, Van Der Bruggen CEE, Kurakula K, Sun XQ, Casali KR, Casali AG, Rol N, Szulcek R, Dos Remedios C, Guignabert C, Tu L, Dorfmuller P, Humbert M, Wijnker PJM, Kuster DWD, van der Velden J, Goumans MJ, Bogaard HJ, Vonk-Noordegraaf A, de Man FS, Handoko ML. Contribution of Impaired Parasympathetic Activity to Right Ventricular Dysfunction and Pulmonary Vascular Remodeling in Pulmonary Arterial Hypertension. Circulation. 2018 Feb 27;137(9):910-924. doi: 10.1161/CIRCULATIONAHA.117.027451. Epub 2017 Nov 22.
PubMed 29167228Lahiri MK, Kannankeril PJ, Goldberger JJ. Assessment of autonomic function in cardiovascular disease: physiological basis and prognostic implications. J Am Coll Cardiol. 2008 May 6;51(18):1725-33. doi: 10.1016/j.jacc.2008.01.038.
PubMed 18452777Vonk Noordegraaf A, Galie N. The role of the right ventricle in pulmonary arterial hypertension. Eur Respir Rev. 2011 Dec;20(122):243-53. doi: 10.1183/09059180.00006511.
PubMed 22130817Vonk-Noordegraaf A, Haddad F, Chin KM, Forfia PR, Kawut SM, Lumens J, Naeije R, Newman J, Oudiz RJ, Provencher S, Torbicki A, Voelkel NF, Hassoun PM. Right heart adaptation to pulmonary arterial hypertension: physiology and pathobiology. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D22-33. doi: 10.1016/j.jacc.2013.10.027.
PubMed 24355638
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ArrhythmiaS in Pulmonary arterIal hypeRtEnsion and Right Heart Failure Assessed by Continuous Long-term Cardiac Monitoring
- ClinicalTrials.gov ID
- NCT04554160
- Acronym / sponsor ID
- ASPIRE / H-18005164
- Keywords
- arrhythmias, Heart rate variability, Pulmonary Hypertension, Risk assessment, Continuous heart monitoring via wearables
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Actelion
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 studies.
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 hypertension.
In conclusion the ASPIRE study will:
- 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.
- The investigators will assess the arrhythmic burden in relation to:
- Change in 6 MWT
- Hemodynamic changes with RHC
- Hemodynamic changes in echocardiography
- The number of patients progressing one FC (Modified NYHA class)
- Changes in NT-proBNP.
- Hospital admission for any reason
- Death or transplantation
- Monitor heart rate variability and address a comparison to known risk markers and CMR and echocardiography. The study specifically seeks to investigate following:
- The incidence and type of supraventricular and ventricular arrhythmias in PH by continuous long-term monitoring
- The predictive value of both right and left ventricular cardiac magnetic resonance (CMR) imaging parameters for arrhythmogenesis in PAH, heart rate variability, and heart rate.
- Optimization of specific therapy in PAH using continuous long-term arrhythmia monitoring
- Monitor patients using smart watches (apple watches) to evaluate the applicability of long-term monitoring via apple watches in patients with pulmonary hypertension for irsk asessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with pulmonary hypertension: 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
Key inclusion criteria (13 listed)
- Pulmonary hypertension patients >18 years of age
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loop recorder implantationAlso: Reveal LINQ loop recorderA loop recorder is implanted in the start of the study after informed consent is signed and enables continuous cardiac monitoring. | Device | – |
| A smartwatchAlso: Apple watchA subgroup of the patients will be given an apple watch after informed consent to enables continuous monitoring via this non-invasive modality. | Device | – |
Primary outcome
The incidence and prevalence of arrhythmias in pulmonary hypertension
Time frame: 2022
Assessed throughout continuous cardiac monitoring
Heart rate variability
Time frame: 2023
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.
Arrhythmias and their impact on heart function assessed with echocardiography
Time frame: 2022
Change in function of the right and left heart chambers in the patients' with and without arrhythmias assessed with echocardiography.
Heart rate variability and heart function assessed with CMR scans.
Time frame: 2022
The patients' heart rate variability will be compared to the function of the right and left ventricle (LVEF, RVEF)
Heart rate variability and chamber sizes assessed CMR scans
Time frame: 2023
The patients' heart rate variability will be compared to the size of the right and left ventricle (ml)
Change in heart function when having arrhythmias, assessed with CMR scans.
Time frame: 2023
The patients' arrhythmic burden will be compared to the function of the right and left ventricle (LVEF, RVEF)
Heart size in the group with and without arrhythmias, assessed with CMR scans.
Time frame: 2023
The patients' arrhythmic burden will be compared to the size of the right and left ventricle (ml).
Chamber sizes in patients with and without arrhythmias assessed with echocardiography.
Time frame: 2023
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.
The association between variables recorded via the apple watch and current risk assessment parameters in PH
Time frame: 2024
Association models between the variables in order to assess the apple watch applicability for risk assessment.
1 secondary outcome
Arrhythmias and their impact on WHO functional class
Time frame: 2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 24355641Hoeper MM, Bogaard HJ, Condliffe R, Frantz R, Khanna D, Kurzyna M, Langleben D, Manes A, Satoh T, Torres F, Wilkins MR, Badesch DB. Definitions and diagnosis of pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D42-50. doi: 10.1016/j.jacc.2013.10.032.
- Background: PubMed 17174650Tongers J, Schwerdtfeger B, Klein G, Kempf T, Schaefer A, Knapp JM, Niehaus M, Korte T, Hoeper MM. Incidence and clinical relevance of supraventricular tachyarrhythmias in pulmonary hypertension. Am Heart J. 2007 Jan;153(1):127-32. doi: 10.1016/j.ahj.2006.09.008.
- Background: PubMed 25217453Wen L, Sun ML, An P, Jiang X, Sun K, Zheng L, Liu QQ, Wang L, Zhao QH, He J, Jing ZC. Frequency of supraventricular arrhythmias in patients with idiopathic pulmonary arterial hypertension. Am J Cardiol. 2014 Nov 1;114(9):1420-5. doi: 10.1016/j.amjcard.2014.07.079. Epub 2014 Aug 13.
- Background: PubMed 22727973Olsson KM, Nickel NP, Tongers J, Hoeper MM. Atrial flutter and fibrillation in patients with pulmonary hypertension. Int J Cardiol. 2013 Sep 1;167(5):2300-5. doi: 10.1016/j.ijcard.2012.06.024. Epub 2012 Jun 22.
- Background: PubMed 26320113Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
- Background: PubMed 29636972Wanamaker B, Cascino T, McLaughlin V, Oral H, Latchamsetty R, Siontis KC. Atrial Arrhythmias in Pulmonary Hypertension: Pathogenesis, Prognosis and Management. Arrhythm Electrophysiol Rev. 2018 Mar;7(1):43-48. doi: 10.15420/aer.2018.3.2.
- Background: PubMed 29575972Mercurio V, Peloquin G, Bourji KI, Diab N, Sato T, Enobun B, Housten-Harris T, Damico R, Kolb TM, Mathai SC, Tedford RJ, Tocchetti CG, Hassoun PM. Pulmonary arterial hypertension and atrial arrhythmias: incidence, risk factors, and clinical impact. Pulm Circ. 2018 Apr-Jun;8(2):2045894018769874. doi: 10.1177/2045894018769874. Epub 2018 Mar 26.
- Background: PubMed 26522342Cannillo M, Grosso Marra W, Gili S, D'Ascenzo F, Morello M, Mercante L, Mistretta E, Salera D, Zema D, Bissolino A, Fusaro E, Marra S, Libertucci D, Gaita F. Supraventricular Arrhythmias in Patients With Pulmonary Arterial Hypertension. Am J Cardiol. 2015 Dec 15;116(12):1883-9. doi: 10.1016/j.amjcard.2015.09.039. Epub 2015 Oct 9.
- Background: PubMed 30747032Cirulis MM, Ryan JJ, Archer SL. Pathophysiology, incidence, management, and consequences of cardiac arrhythmia in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Pulm Circ. 2019 Jan-Mar;9(1):2045894019834890. doi: 10.1177/2045894019834890.
- Background: PubMed 23009914Rajdev A, Garan H, Biviano A. Arrhythmias in pulmonary arterial hypertension. Prog Cardiovasc Dis. 2012 Sep-Oct;55(2):180-6. doi: 10.1016/j.pcad.2012.06.002.
- Background: PubMed 14749936Folino AF, Bobbo F, Schiraldi C, Tona F, Romano S, Buja G, Bellotto F. Ventricular arrhythmias and autonomic profile in patients with primary pulmonary hypertension. Lung. 2003 Nov-Dec;181(6):321-8. doi: 10.1007/s00408-003-1034-x.
- Background: PubMed 29167228da Silva Goncalves Bos D, Van Der Bruggen CEE, Kurakula K, Sun XQ, Casali KR, Casali AG, Rol N, Szulcek R, Dos Remedios C, Guignabert C, Tu L, Dorfmuller P, Humbert M, Wijnker PJM, Kuster DWD, van der Velden J, Goumans MJ, Bogaard HJ, Vonk-Noordegraaf A, de Man FS, Handoko ML. Contribution of Impaired Parasympathetic Activity to Right Ventricular Dysfunction and Pulmonary Vascular Remodeling in Pulmonary Arterial Hypertension. Circulation. 2018 Feb 27;137(9):910-924. doi: 10.1161/CIRCULATIONAHA.117.027451. Epub 2017 Nov 22.
- Individual participant dataSharing planned: No
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Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jørn Carlsen, MD, DMSC study director
MD at Copenhagen University Hospital, Rigshospitalet 9- Blegdamsvej
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Arrhythmias, Cardiac, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jørn Carlsen, MD, DMSc, FESC ((+45) 35458060, joern.carlsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and prevalence of arrhythmias in pulmonary hypertension (time frame: 2022). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04554160, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.