The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the Interior Vena Cava
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension, Pulmonary
- Sponsor
- Cardioflow Technologies, LLC
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Reduction in respiratory rate at matched levels of exercise.
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects scheduled to undergo an exercise right heart catheterization at El Camino Hospital.
- •New York Heart Association (NYHA) II or III.
- •Subjects must be between 18 and 80 years of age.
- •A left ventricular ejection fraction ≥ 35%.
- •Subjective or objective evidence (e.g. 6 minute walk test) of impaired exercise capacity.
- •Is willing and able to sign an IRB-approved written informed consent
Exclusion Criteria
- •Inability to peddle exercise while laying flat.
- •More than mild valve disease.
- •Clinical or objective evidence of inducible myocardial ischemia.
- •Significant lung disease, such as prior diagnosis of COPD.
- •Resting or dynamic outflow tract gradient.
- •Severe pulmonary HTN (\>60mmHg at rest)
- •Moderate to severe RV dysfunction
- •History of DVT, PE
- •Pregnancy (women of child-bearing age, regardless of contraceptive measures, must be willing to take a pregnancy test prior to the study).
- •Recent major surgery or hospitalization (within 30 days)
Outcomes
Primary Outcomes
Reduction in respiratory rate at matched levels of exercise.
Time Frame: During the CPET, within 30 minutes of study.
Secondary Outcomes
- Change in ventilatory threshold(During the CPET, within 30 minutes of study.)
- Change in pulmonary diastolic pressure for a given level of exercise (work rate)(During the CPET, within 30 minutes of study.)
- Change in heart rate for given level of exercise (work rate in watts)(During the CPET, within 30 minutes of study.)
- Change in exercise time(During the CPET, within 30 minutes of study.)
- Change in oxygen uptake at a given level of exercise(During the CPET, within 30 minutes of study.)
- Change in pH level at a given level of exercise(During the CPET, within 30 minutes of study.)
- Change in cardiac output at a given level of exercise(During the CPET, within 30 minutes of study.)
- Change in patient symptoms-- dyspnea and leg discomfort (Borg units)(During the CPET, within 30 minutes of study.)
- Change in Peak VO2(During the CPET, within 30 minutes of study.)
- Determining predictors of peak VO2(During the CPET, within 30 minutes of study.)
- Change in anaerobic threshold(During the CPET, within 30 minutes of study.)
- Change in dead space ventilation at a given level of exercise (and VE/VCO2 slope)(During the CPET, within 30 minutes of study.)