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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    40
  • sponsor
    Rigshospitalet, Denmark
Updated on 17 May 2022
hypertension
heart disease
cardiac monitoring
pulmonary arterial hypertension
right heart catheterization

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.

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:

  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:
    • 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
  3. 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

Details
Condition Pulmonary Hypertension, Arrhythmias, Cardiac, Heart Rate Variability
Treatment Loop recorder implantation
Clinical Study IdentifierNCT04554160
SponsorRigshospitalet, Denmark
Last Modified on17 May 2022

Eligibility

Yes No Not Sure

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
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

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
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