Heart Failure Clinical Trial
Official title:
Hemodynamic Testing Strategies to Assess Pulmonary Hypertension and Right Ventricular Function in Heart Failure Patients
| NCT number | NCT05672719 |
| Other study ID # | G21-0031553 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 19, 2021 |
| Est. completion date | June 2025 |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Mount Sinai Hospital | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Mount Sinai Hospital, Canada | Heart and Stroke Foundation of Canada |
Canada,
| 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 |
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