Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure

January 4, 2023 updated by: Mount Sinai Hospital, Canada

Hemodynamic Testing Strategies to Assess Pulmonary Hypertension and Right Ventricular Function in Heart Failure Patients

The goal of this observational study is to learn about heart function and high lung blood pressure in patients with heart failure. The main question[s] it aims to answer are whether we can improve the ability to predict patients who will have complications after they receive treatment including heart transplant and left ventricular assist devices.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective cohort study of patients with heart failure with reduced ejection fraction that are referred for diagnostic right heart catheterization as part of their evaluation for candidacy for advanced heart failure therapies.

Study Type

Observational

Enrollment (Anticipated)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients assessed in the advanced heart failure program for heart transplant candidacy at the University of Toronto referred for right heart catheterization.

Description

Inclusion Criteria:

  • Adults age 18 years or older
  • Heart failure with reduced ejection fraction (<40%)
  • referred for RHC at our centre for evaluation of candidacy for advanced HF therapies.

Exclusion Criteria:

Severe valvular or complex congenital heart disease Short-term mechanical circulatory support for progressive cardiogenic shock (e.g. extracorporeal membrane oxygenation) Acute coronary syndrome or revascularization occurred within 7 days prior to the RHC.

Pregnant or breast-feeding Known hypersensitivity to sodium nitroprusside Advanced liver dysfunction Reduced capacity or inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean pulmonary artery pressure
Time Frame: First study 1 day visit
Hemodynamic measurement
First study 1 day visit
right ventricular end systolic elastance
Time Frame: First study 1 day visit
Hemodynamic measurement
First study 1 day visit
pulmonary arterial elastance
Time Frame: First study 1 day visit
hemodynamic measurement
First study 1 day visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Right ventricular failure after heart transplant
Time Frame: 1 year
Clinical outcome
1 year
Right ventricular failure after left ventricular assist device
Time Frame: 1 year
Clinical outcome
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
right ventricular pulmonary arterial elastance coupling response to vasodilator
Time Frame: First study 1 day visit
Hemodynamic measurement
First study 1 day visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Collaborators

Heart and Stroke Foundation of Canada

Investigators

  • Principal Investigator: Susanna Mak, MD PhD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G21-0031553

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Agreements to share participant data can be requested after study completion and publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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