Monitoring heart rhythms in patients with pulmonary hypertension using wearable technology

ArrhythmiaS in Pulmonary arterIal hypeRtEnsion and Right Heart Failure Assessed by Continuous Long-term Cardiac Monitoring

This study is testing how well a smartwatch and a loop recorder can help track heart rhythms in people with pulmonary hypertension to see if it can improve their treatment and care.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rigshospitalet, Denmark (other)
• Locations: 1 site (Copenhagen)
• Trial ID: NCT04554160 on ClinicalTrials.gov

What this trial studies

This study aims to assess the prevalence of arrhythmias in patients with pulmonary hypertension (PH) through continuous long-term cardiac monitoring. It will utilize both a loop recorder, considered the gold standard, and a smartwatch to evaluate heart rate variability and its correlation with various risk assessment parameters. By focusing on patients with different subtypes of PH, the study seeks to provide a comprehensive understanding of the arrhythmic burden and its implications for treatment optimization. The findings could lead to improved risk assessment and management strategies for patients with PH.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years with a confirmed diagnosis of pulmonary hypertension who are either treatment-naïve or currently on PAH-specific medications.

Not a fit: Patients with severe comorbidities or those who do not meet the inclusion criteria for pulmonary hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of arrhythmias in pulmonary hypertension, leading to better patient management and outcomes.

How similar studies have performed: While some studies have shown lower heart rate variability in pulmonary hypertension, this approach of long-term monitoring using wearables is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Copenhagen

• Department of Cardiology 2141 Copenhagen University Hospital, Rigshospitalet 9- Blegdamsvej — Copenhagen, Denmark (RECRUITING)

Study contacts

• Study coordinator: Jørn Carlsen, MD, DMSc, FESC

Conditions: Pulmonary Hypertension, Arrhythmias, Cardiac, Heart Rate Variability, Risk Assessment, arrhythmias, Heart rate variability, Risk assessment, Continuous heart monitoring via wearables