NCT05587400

Brief Summary

Currently, the gold standard method to estimate CO in patients with PAH or RV dysfunction is pulmonary artery catheter (PAC), however, the invasiveness and complexity of PAC has limited its usefulness in many clinical scenarios. By measuring the thoracic electrical bioimpedance, electrical cardiometry (EC) technique has been reported to noninvasively estimate cardiac output (CO) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. However, in patients with pulmonary arterial hypertension (PAH) and/or right ventricular (RV) dysfunction, few study has been reported. The aim of this study is to evaluate the agreement between CO measured by PAC as the referenced method and CO measured by EC technique in patients with PAH and/or RV dysfunction.

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
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

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

July 27, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

September 23, 2022

Last Update Submit

October 19, 2022

Conditions

Pulmonary Arterial HypertensionRight Ventricular Dysfunction

Outcome Measures

Primary Outcomes (12)

  • cardiac output by pulmonary artery catheter

    measuring cardiac output using pulmonary artery catheter

    5minutes after the patients was sedated

  • cardiac output by electrical cardiometry

    measuring cardiac output using electrical cardiometry

    5minutes after the patients was sedated

  • cardiac output by pulmonary artery catheter

    measuring cardiac output using pulmonary artery catheter

    2 minutes after passive leg raising

  • cardiac output by electrical cardiometry

    measuring cardiac output using electrical cardiometry

    2 minutes after passive leg raising

  • cardiac output by pulmonary artery catheter

    measuring cardiac output using pulmonary artery catheter

    15 minutes after termination of passive leg raising

  • cardiac output by electrical cardiometry

    measuring cardiac output using electrical cardiometry

    15 minutes after termination of passive leg raising

  • cardiac output by pulmonary artery catheter

    measuring cardiac output using pulmonary artery catheter

    30 minutes after dobutamine infusion

  • cardiac output by electrical cardiometry

    measuring cardiac output using electrical cardiometry

    30 minutes after dobutamine infusion

  • cardiac output by pulmonary artery catheter

    measuring cardiac output using pulmonary artery catheter

    30 minutes after termination of dobutamine infusion

  • cardiac output by electrical cardiometry

    measuring cardiac output using electrical cardiometry

    30 minutes after termination of dobutamine infusion

  • cardiac output by pulmonary artery catheter

    measuring cardiac output using pulmonary artery catheter

    30 minutes after nitric oxide inhalation

  • cardiac output by electrical cardiometry

    measuring cardiac output using electrical cardiometry

    30 minutes after nitric oxide inhalation

Study Arms (1)

patients with pulmonary artery hypertension and/or right ventricular dysfunction

EXPERIMENTAL
Behavioral: passive leg raisingDrug: dobutamine testDrug: inhaled nitric oxide

Interventions

passive leg raisingBEHAVIORAL

transfer a patient from semi-recumbent position to supine position with a 45° leg lifting

patients with pulmonary artery hypertension and/or right ventricular dysfunction
dobutamine testDRUG

infusion dobutamine

patients with pulmonary artery hypertension and/or right ventricular dysfunction
inhaled nitric oxideDRUG

nitric oxide inhalation

patients with pulmonary artery hypertension and/or right ventricular dysfunction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult cardiac surgery patients
  • pulmonary artery hypertension and/or right heart dysfunction
  • mechanical ventilation

You may not qualify if:

  • life threatening arrhythmia
  • severe valve regurgitation
  • left ventricular ejection fraction less than 30%
  • patients with mechanical circulatory support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial HypertensionVentricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract DiseasesVentricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Officials

  • Guang-wei Hao, PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Luo, PhD

CONTACT

02164041990luo.zhe@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

October 20, 2022

Study Start

July 27, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

CN(1)