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RecruitingNCT05672719Updated Jan 5, 2023

Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure

An observational study in Heart Failure, sponsored by Mount Sinai Hospital, Canada. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-05.

Sponsored by Mount Sinai Hospital, Canada · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Oct 2021; still recruiting 4 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
74
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 74 is below the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Mount Sinai Hospital, Canada is the lead sponsor of 157 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
74 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testRight Heart Catheterization

    Procedure

06

What researchers measure

Primary outcomes

  1. Mean pulmonary artery pressure

    Hemodynamic measurement

    Time frame: First study 1 day visit

  2. right ventricular end systolic elastance

    Hemodynamic measurement

    Time frame: First study 1 day visit

  3. pulmonary arterial elastance

    hemodynamic measurement

    Time frame: First study 1 day visit

Secondary outcomes

  1. Right ventricular failure after heart transplant

    Clinical outcome

    Time frame: 1 year

  2. Right ventricular failure after left ventricular assist device

    Clinical outcome

    Time frame: 1 year

Other outcomes

  1. right ventricular pulmonary arterial elastance coupling response to vasodilator

    Hemodynamic measurement

    Time frame: First study 1 day visit

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided — Agreements to share participant data can be requested after study completion and publication.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05672719
Lead sponsor
Mount Sinai Hospital, Canada
Collaborators
Heart and Stroke Foundation of Canada
Responsible party
Sponsor
First posted
Jan 5, 2023
Start date
Oct 19, 2021
Primary completion
Jun 2024 (estimated)
Completion
Jun 2025 (estimated)
Last update
Jan 5, 2023

Study contacts

Susanna Mak, MD PhD
Contact
susanna.mak@sinaihealth.ca
4165864800 ext. 5554
Susanna Mak, MD PhD
principal investigator · University of Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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