Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure
1 other identifier
observational
74
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2021
CompletedFirst Submitted
Initial submission to the registry
January 3, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedJanuary 5, 2023
December 1, 2022
2.6 years
January 3, 2023
January 4, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Mean pulmonary artery pressure
Hemodynamic measurement
First study 1 day visit
right ventricular end systolic elastance
Hemodynamic measurement
First study 1 day visit
pulmonary arterial elastance
hemodynamic measurement
First study 1 day visit
Secondary Outcomes (2)
Right ventricular failure after heart transplant
1 year
Right ventricular failure after left ventricular assist device
1 year
Other Outcomes (1)
right ventricular pulmonary arterial elastance coupling response to vasodilator
First study 1 day visit
Interventions
Procedure
Eligibility Criteria
Patients assessed in the advanced heart failure program for heart transplant candidacy at the University of Toronto referred for right heart catheterization.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susanna Mak, MD PhD
University of Toronto
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2023
First Posted
January 5, 2023
Study Start
October 19, 2021
Primary Completion
June 1, 2024
Study Completion
June 1, 2025
Last Updated
January 5, 2023
Record last verified: 2022-12