NCT04663230

Brief Summary

The study aim to assess right atrial (RA) remodeling, in terms of RA fibrosis, in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension patients. This will be investigated in detail with in-depth cardiac magnet resonance imaging (CMRI). A cohort with exclusion of pulmonary hypertension which underwent CMRI due to dyspnoe of unkown reason will be the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 30, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

1.6 years

First QC Date

November 9, 2020

Last Update Submit

May 16, 2024

Conditions

Pulmonary HypertensionChronic Thromboembolic Pulmonary HypertensionPulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • atrial fibrosis

    right atrial late gadolinium enhancement in % and cm2

    1 day

Secondary Outcomes (6)

  • Correlation of right atrial fibrosis with functional and exercise capacity

    1 day

  • Correlation of right atrial fibrosis with remodeling of the right atrium, backflow and systemic congestion

    1 day

  • Correlation of right atrial fibrosis with pulmonary hemodynamics

    1 day

  • Correlation of right atrial fibrosis with load-independent right ventricular function assessed by pressure-volume loop catheterization

    1 day

  • Correlation of right atrial fibrosis with biomarkers

    1 day

  • +1 more secondary outcomes

Study Arms (3)

Pulmonary arterial hypertension

Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg classified into group 1 of the clinical classification of pulmonary hypertension.

Diagnostic Test: cardiac magnetic resonance imaging

Chronic thromboembolic pulmonary hypertension

Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg with a history of pulmonary embolism, classified into group 4 of the clinical classification of pulmonary hypertension.

Diagnostic Test: cardiac magnetic resonance imaging

Control

Patients with invasive exclusion of pulmonary hypertension (mean pulmonary arterial pressure below 25 mmHg) undergoing diagnostic CMRI due to the evaluation of dyspnoea.

Diagnostic Test: cardiac magnetic resonance imaging

Interventions

cardiac magnetic resonance imagingDIAGNOSTIC_TEST

right atrial late gadolinium enhancement in % and cm2

Chronic thromboembolic pulmonary hypertensionControlPulmonary arterial hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 subjects with pulmonary arterial hypertension, group 1 and chronic thromboembolic pulmonary hypertension, group 4; Patients with invasive exclusion of pulmonary hypertension undergoing diagnostic right heart catheterisation due to dyspnoe will serve as control

You may qualify if:

  • Confirmed diagnosis of pulmonary arterial hypertension, WHO group 1 or chronic thromboembolic pulmonary hypertension, group 4
  • Age ≥ 18 years
  • Signed informed consent
  • planned right heart catheterization based on clinical grounds

You may not qualify if:

  • Other etiologic groups of pulmonary hypertension (WHO group 2, 3, 5)
  • Patients with congenital heart disease
  • Atrial septal defects
  • Clinical relevant left heart disease
  • Atrial fibrillation / Atrial flutter
  • Ablations of the right atrium
  • History of major cardiac surgery
  • Atrial occlude
  • Metallic implants
  • Pacemakers
  • Severe renal impairment (eGFR \< 30 ml/min)
  • Other severe disease with a life expectancy below 12 month
  • Pregnancy
  • Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results
  • Intolerance to a contrast agent containing gadolinium
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kerckhoff-Klinik

Bad Nauheim, Hesse, Germany

Location

University of Giessen

Giessen, Hesse, 35390, Germany

Location

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Richter Manuel, MD

    UKGM Giessen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

December 10, 2020

Study Start

April 30, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2023

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations

DE(2)