Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure

Heart Failure Clinical Trial

Official title:

Hemodynamic Testing Strategies to Assess Pulmonary Hypertension and Right Ventricular Function in Heart Failure Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672719
• Other study ID #: G21-0031553
• Status: Recruiting
• Start date: October 19, 2021
• Est. completion date: June 2025

Study information

• Verified date: December 2022
• Source: Mount Sinai Hospital, Canada
• Contact: Susanna Mak, MD PhD
• Phone: 4165864800
• Email: susanna.mak[@]sinaihealth.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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 left ventricular assist devices.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Hypertension
• Hypertension, Pulmonary

Intervention

Diagnostic Test:
• Right Heart Catheterization
Procedure

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	right ventricular pulmonary arterial elastance coupling response to vasodilator	Hemodynamic measurement	First study 1 day visit
Primary	Mean pulmonary artery pressure	Hemodynamic measurement	First study 1 day visit
Primary	right ventricular end systolic elastance	Hemodynamic measurement	First study 1 day visit
Primary	pulmonary arterial elastance	hemodynamic measurement	First study 1 day visit
Secondary	Right ventricular failure after heart transplant	Clinical outcome	1 year
Secondary	Right ventricular failure after left ventricular assist device	Clinical outcome	1 year