The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the IVC
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/17/2018 |
| Start Date: | December 2016 |
| End Date: | June 2019 |
| Contact: | Daniel W Kaiser, MD |
| Email: | danielkaisermd@gmail.com |
The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the Interior Vena Cava
In patients with heart failure, elevated filling pressures may contribute to symptoms while
not improving cardiac output. The current study is focused on evaluating the relationship
between exercise capacity, pulmonary pressures, cardiopulmonary parameters, and symptoms of
dyspnea in patients with heart failure during exercise.
not improving cardiac output. The current study is focused on evaluating the relationship
between exercise capacity, pulmonary pressures, cardiopulmonary parameters, and symptoms of
dyspnea in patients with heart failure during exercise.
Previous studies have suggested that intracardiac pressures can be decreased without
compromising cardiac function. During an invasive cardiopulmonary exercise test (CPET),
catheters are placed within the heart and pulmonary vasculature to evaluate cardiopulmonary
function in response to exercise. We will be testing whether pulmonary hypertension can be
prevented during exercise by adjusting right ventricular pre-load. We will also be evaluating
parameters of cardiopulmonary function during the study.
compromising cardiac function. During an invasive cardiopulmonary exercise test (CPET),
catheters are placed within the heart and pulmonary vasculature to evaluate cardiopulmonary
function in response to exercise. We will be testing whether pulmonary hypertension can be
prevented during exercise by adjusting right ventricular pre-load. We will also be evaluating
parameters of cardiopulmonary function during the study.
Inclusion Criteria:
1. Subjects scheduled to undergo an exercise right heart catheterization at El Camino
Hospital.
2. New York Heart Association (NYHA) II or III.
3. Subjects must be between 18 and 80 years of age.
4. A left ventricular ejection fraction ≥ 35%.
5. Subjective or objective evidence (e.g. 6 minute walk test) of impaired exercise
capacity.
6. Is willing and able to sign an IRB-approved written informed consent
Exclusion Criteria:
1. Inability to peddle exercise while laying flat.
2. More than mild valve disease.
3. Clinical or objective evidence of inducible myocardial ischemia.
4. Significant lung disease, such as prior diagnosis of COPD.
5. Resting or dynamic outflow tract gradient.
6. Severe pulmonary HTN (>60mmHg at rest)
7. Moderate to severe RV dysfunction
8. History of DVT, PE
9. Pregnancy (women of child-bearing age, regardless of contraceptive measures, must be
willing to take a pregnancy test prior to the study).
10. Recent major surgery or hospitalization (within 30 days)
11. Participation in another clinical study (within 30 days)
12. Advanced neurological disease (e.g. dementia)
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El Camino Hospital El Camino Hospital is a nonprofit organization with hospital campuses in Mountain...
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