Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT05672719
• Lead Sponsor: Mount Sinai Hospital, Canada

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.

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 Timeline

• Study Start: 2021-10-19
• Status Verified: 2022-12
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-04
• Last Update Submitted: 2023-01-04
• Study First Posted: 2023-01-05
• Last Update Posted: 2023-01-05
• Primary Completion: 2024-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
right ventricular end systolic elastance	First study 1 day visit	Hemodynamic measurement
pulmonary arterial elastance	First study 1 day visit	hemodynamic measurement
Mean pulmonary artery pressure	First study 1 day visit	Hemodynamic measurement

Secondary Outcome Measures

Name	Time	Method
Right ventricular failure after heart transplant	1 year	Clinical outcome
Right ventricular failure after left ventricular assist device	1 year	Clinical outcome

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada