NCT01972009

Brief Summary

The mechanism governing how blood flows from the heart to the lungs depends on many factors including the pumping function of the right ventricle, properties of the arteries that carry the blood from the right ventricle to the lungs (pulmonary arteries), and the lungs themselves. Under normal conditions the pressure in the pulmonary arteries is well controlled and significantly lower than in the systemic circulation, however there are a number of conditions that lead to abnormally high pressures and significant morbidity and mortality. However different patients respond differently to similarly elevated pressures, leading doctors to believe that there must be differences in either the right ventricles, the properties of the arteries, or the lungs themselves. It can be difficult to determine the relative contributions of each of these factors on blood flow because their effects are superimposed on each other. One approach that has been used to look at this in other parts of the circulation (including in the systemic circulation and the coronary arteries) is to measure simultaneous pressure and flow, and apply a technique called wave intensity analysis (WIA). This technique can amongst other things, quantify the separate effects of wave reflection and the 'reservoir function' (or compliance) of the arteries, and in the systemic circulation WIA has increased the understanding of the mechanisms behind hypertension and the physiological changes of ageing. The pulmonary arteries are accepted to be very different from the systemic circulation and the mechanisms behind pulmonary hypertension are thought to be very different to those of systemic hypertension. This protocol aims to determine the major influences on blood flow in the pulmonary arteries in health and disease, to help to understand why some patients are affected more than others by elevated pulmonary pressures.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

1.9 years

First QC Date

October 24, 2013

Last Update Submit

October 31, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Wave reflection coefficient

    6 months

Secondary Outcomes (1)

  • Reservoir function

    6 months

Study Arms (2)

Subjects without pulmonary hypertension

Patients with normal pulmonary pressures will be recruited amongst patients who are on the waiting list awaiting routine cardiac catheterisation for the investigation of shortness of breath and chest pain.

Procedure: Cardiac catheterisation

Subjects with pulmonary hypertension

Patients with pulmonary hypertension will be recruited from the National Pulmonary Hypertension Service who are awaiting right and left heart catheterisation studies as part of their routine diagnostic work-up.

Procedure: Cardiac catheterisation

Interventions

Simultaneous measurement of pressure and flow velocity in the pulmonary artery is achieved during right heart catheterisation by passing a catheter as per usual practice into the pulmonary artery, a purpose-designed wire (Combiwire) will then be advanced approximately 1 cm beyond the end of the catheter. The data obtained will be used for wave intensity analysis.

Subjects with pulmonary hypertensionSubjects without pulmonary hypertension

Eligibility Criteria

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

Patients with normal pulmonary pressures will be recruited from patients who are on the waiting list awaiting routine cardiac catheterisation at Hammersmith Hospital for the investigation of shortness of breath and chest pain. Patients with pulmonary hypertension will be recruited from the National Pulmonary Hypertension Service, Hammersmith Hospital, who are awaiting right and left heart catheterisation studies as part of their routine diagnostic work up.

You may qualify if:

  • \- Adult patients undergoing right and left heart catheterisation.

You may not qualify if:

  • under 18 years of age
  • atrial fibrillation
  • chronic renal failure (eGFR \<30)
  • unable to exercise
  • unable to consent
  • pulmonary embolism in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart and Lung Institute, Imperial College London

London, London, W2 1LA, United Kingdom

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Cardiac Catheterization

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisCatheterizationTherapeuticsInvestigative Techniques

Study Officials

  • Charlotte Manisty, MRCP PhD

    National Heart and Lung Institute, Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Manisty, MRCP PHD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2013

First Posted

October 30, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations