NCT03061669

Brief Summary

Respiratory monitoring during right heart catheterization to differentiate between various types of pulmonary hypertension; The effects of the cardiovascular system on the lung mechanical properties.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

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

First Submitted

Initial submission to the registry

February 3, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

February 26, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2.9 years

First QC Date

February 3, 2017

Last Update Submit

August 26, 2019

Conditions

Pulmonary HypertensionHeart Failure

Keywords

heart failurepulmonary hypertensionright heart catheterization

Outcome Measures

Primary Outcomes (3)

  • Pulmonary artery pressure

    In mmHg measured by Swan-Ganz catheter

    only during the procedure of right heart catheterization

  • Respiratory flow

    ml units

    only during the procedure of right heart catheterization

  • Chest wall acceleration

    local tidal displacement

    only during the procedure of right heart catheterization

Secondary Outcomes (2)

  • Right ventricle pressure

    only during the procedure of right heart catheterization

  • Pulmonary artery wedge pressure

    only during the procedure of right heart catheterization

Eligibility Criteria

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

Patients undergoing right heart catheterization (RHC) for the evaluation of heart failure and pulmonary hypertension, based on the regular clinical practice.

You may qualify if:

  • Patients undergoing right heart catheterization

You may not qualify if:

  • Inability or unwillingness to follow or to sign the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam medical center

Haifa, 3109601, Israel

RECRUITING

MeSH Terms

Conditions

Hypertension, PulmonaryHeart Failure

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesHeart Diseases

Study Officials

  • Yair Feld, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yair Feld, MD

CONTACT

+972-47772181y_feld@rmc.gov.il

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 23, 2017

Study Start

February 26, 2017

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)