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

NCT04554160 | Unknown DMC FDA Device

• 1 other identifier: H-18005164
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

arrhythmias; Heart rate variability; Pulmonary Hypertension; Risk assessment; Continuous heart monitoring via wearables

Outcome Measures

Primary Outcomes (9)

• The incidence and prevalence of arrhythmias in pulmonary hypertension

  Assessed throughout continuous cardiac monitoring

  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.

  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.

  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)

  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)

  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)

  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).

  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.

  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.

  2024

Secondary Outcomes (1)

• Arrhythmias and their impact on WHO functional class

  2022

Other Outcomes (4)

• Arrhythmias and their impact on death or transplantation

  2022

• Arrhythmias impact on specific PAH therapy

  2022

• Arrhythmias impact on six minute walking tests

  2022

Interventions

Loop recorder implantation DEVICE

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

Also known as: Reveal LINQ loop recorder

A smartwatch DEVICE

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

Also known as: Apple watch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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
• MWT distances of ≥50 meters and within 15% of each other on 2 consecutive tests preferably performed on different days during Screening.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Actelion: collaborator

Study Sites (1)

Department of Cardiology 2141 Copenhagen University Hospital, Rigshospitalet 9- Blegdamsvej

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (35)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

There willl be taken 10 ml of blood for each visit (6 visits in total), of which the excess amount will be stored in a biobank. The material is stored for up to 25 years following.

MeSH Terms

Conditions

Hypertension, Pulmonary; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jørn Carlsen, MD, DMSC

  MD at Copenhagen University Hospital, Rigshospitalet 9- Blegdamsvej

  STUDY DIRECTOR

Central Study Contacts

Jørn Carlsen, MD, DMSc, FESC

CONTACT

(+45) 35458060; joern.carlsen@regionh.dk

Mads Andersen, MD

CONTACT

(+45) 21636430; mads.oerbeak.andersen.01@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, DMSc

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 18, 2020
• Study Start: September 24, 2018
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 10, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)