The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the Inferior Vena Cava
Study Type/Phase: Observational
Status: Not Recruiting
This research study will enroll patients suffering from hearth failure who range from mild symptoms (e.g. shortness of breath when walking, climbing stairs, etc.) to marked limitation during less-than-ordinary activity. This study looks at the relationship between pressures inside the heart and the amount of blood the heart pumps, especially during exercise. The goal of this study is to collect information that will advance our understanding of the causes of shortness of breath and may help create new treatments for the symptoms of heart failure.
This research study includes regularly performed cardiac tests to evaluate heart function, including a cardiopulmonary exercise test (CPET) and a right heart catheterization (small plastic tubes placed inside of the heart, used to measure internal heart pressures and volume of blood pumped). In addition to these regularly performed heart tests, this research study has additional steps to evaluate heart function. This aspect of the study is less likely to affect medical therapy and will be performed primarily for research purposes. During this aspect of the study, a catheter with a small inflatable balloon attached at the end in the deflated position will be placed within a large vessel leading to the heart. This balloon will then be inflated while the patient exercises to prevent the heart from becoming pressure overloaded, which is common in patients with heart failure. The theory being tested in this study is whether preventing the heart from developing high pressures will result in improved symptoms during exercise.
Up to 20 people may be enrolled into this research study. The enrollment will occur in the United States only, specifically at El Camino Hospital.
Speak with your doctor to determine whether you meet the following criteria for participation in this study.
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For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.