NCT02391441

Brief Summary

The investigators will evaluate ventricular reversed remodelling after double lung transplantation (LTX) in patients with pulmonary arterial hypertension (PAH), measured with cardiac magnetic resonance imaging (MRI). Reversed remodelling will be compared with control patients without PAH (e.g. Cystic Fibrosis) who will also undergo LTX.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

4.4 years

First QC Date

March 6, 2015

Last Update Submit

August 22, 2019

Conditions

Pulmonary Arterial Hypertension

Keywords

PulmonaryArterialHypertensionLungTransplantationMRI

Outcome Measures

Primary Outcomes (9)

  • Ventricular remodeling on cardiac magnetic resonance

    Absolute increase in RV ejection fraction

    Six months postoperative

  • Ventricular remodeling on cardiac magnetic resonance

    Absolute increase in LV ejection fraction

    Six months postoperative

  • Ventricular remodeling on cardiac magnetic resonance

    Absolute decrease in RV myocardial mass

    Six months postoperative

  • Ventricular remodeling on cardiac magnetic resonance

    Absolute increase in LV myocardial mass

    Six months postoperative

  • Ventricular remodeling on cardiac magnetic resonance

    Absolute decrease in RV end-diastolic volume

    Six months postoperative

  • Ventricular remodeling on cardiac magnetic resonance

    Absolute increase in LV end-diastolic volume

    Six months postoperative

  • Ventricular remodeling on cardiac magnetic resonance

    Restoration of septal displacement

    Six months postoperative

  • Ventricular remodeling on cardiac magnetic resonance

    Decrease in RV myocardial extracellulair volume assessed with T1-mapping

    Six months postoperative

  • Ventricular remodeling on cardiac magnetic resonance

    Decrease in LV end-systolic eccentricity index

    Six months postoperative

Secondary Outcomes (10)

  • Functional remodeling patterns after LTX, assessed with echocardiography

    Six months postoperative

  • Functional remodeling patterns after LTX, assessed with echocardiography

    Six months postoperative

  • Functional remodeling patterns after LTX, assessed with echocardiography

    Six months postoperative

  • Functional remodeling patterns after LTX, assessed with echocardiography

    Six months postoperative

  • Functional remodeling patterns after LTX, assessed with echocardiography

    Six months postoperative

  • +5 more secondary outcomes

Other Outcomes (1)

  • Functional outcome

    Six months postoperative

Study Arms (2)

Pulmonary arterial hypertension

Patients who are on the waiting list for double-LTX for pulmonary arterial hypertension.

Control group

Control patients without increased pulmonary artery pressure (i.e. RV peak pressure \<35 mmHg measured with echocardiography) who are on the waiting list for double-LTX.

Eligibility Criteria

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

Patients with pulmonary arterial hypertension and control patients without increased pulmonary artery pressure who are on the waiting list for double-LTX

You may qualify if:

  • Patients who are on the waiting list for double-LTX, in our institution, for pulmonary arterial hypertension.
  • Eligible for CMR imaging
  • No claustrophobia
  • No pacemaker, ICD, etc.
  • Informed consent

You may not qualify if:

  • Inability to comply with primary endpoint measures.
  • Body mass index ≥40 kg/m2.
  • Pregnant patients will not be included, they may be included \>3 months after pregnancy.
  • Patients with age \<18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Dirk J van Veldhuisen, MD PhD

    University Medical Center Groningen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 18, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 26, 2019

Record last verified: 2019-08

Locations

NL(1)