Heart FailureNCT05672719
Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure
An observational study of Heart Failure, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Right Heart Catheterization
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 19 Oct 2021to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients assessed in the advanced heart failure program for heart transplant candidacy at the University of Toronto referred for right heart catheterization.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Susanna Mak, 4166183017, susanna.mak@sinaihealth.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Right Heart Catheterization
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Heart CatheterizationDiagnostic test
Procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pulmonary artery pressure
Hemodynamic measurement
Measured: First study 1 day visit
right ventricular end systolic elastance
Hemodynamic measurement
Measured: First study 1 day visit
pulmonary arterial elastance
hemodynamic measurement
Measured: First study 1 day visit
Secondary outcomes (2)
Right ventricular failure after heart transplant
Clinical outcome
Measured: 1 year
Right ventricular failure after left ventricular assist device
Clinical outcome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start19 Oct 2021
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Susanna Mak, MD PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672719
- Sponsor's protocol ID
- G21-0031553
- Status last verified
- Dec 2022
- First submitted
- 3 Jan 2023
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Agreements to share participant data can be requested after study completion and publication.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Testing Strategies to Assess Pulmonary Hypertension and Right Ventricular Function in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT05672719
- Acronym / sponsor ID
- G21-0031553
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients assessed in the advanced heart failure program for heart transplant candidacy at the University of Toronto referred for right heart catheterization.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right Heart CatheterizationProcedure | Diagnostic test | – |
Primary outcome
Mean pulmonary artery pressure
Time frame: First study 1 day visit
Hemodynamic measurement
right ventricular end systolic elastance
Time frame: First study 1 day visit
Hemodynamic measurement
pulmonary arterial elastance
Time frame: First study 1 day visit
hemodynamic measurement
2 secondary outcomes
Right ventricular failure after heart transplant
Time frame: 1 year
Right ventricular failure after left ventricular assist device
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Individual participant dataSharing planned: Undecided. Agreements to share participant data can be requested after study completion and publication.
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A Study of Bimagrumab in Participants With HFpEF
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Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna Mak, MD PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanna Mak, MD PhD (4165864800 ext. 5554, susanna.mak@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pulmonary artery pressure (time frame: First study 1 day visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.