Recruiting

Observational Study

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT05672719

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Right Heart Catheterization

Study Details

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.

Conditions

Heart Failure

Study ID

NCT05672719

Start date

Oct 19, 2021

Status verified date

Dec, 2022

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

74 participants

Anticipated

Interventions and Outcome Measures

Interventions

Right Heart Catheterization

Procedure

Primary outcome measure

  • Mean pulmonary artery pressure [ Time Frame: First study 1 day visit ]
  • right ventricular end systolic elastance [ Time Frame: First study 1 day visit ]
  • pulmonary arterial elastance [ Time Frame: First study 1 day visit ]

Central Contacts and Locations

Central contacts

Susanna Mak, MD PhD

4165864800susanna.mak@sinaihealth.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Susanna Mak

4166183017susanna.mak@sinaihealth.ca

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Jan 5, 2023

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2023-01-05.