Heart Failure, Hypertension, Pulmonary
Conditions
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.
Interventions
PROCEDUREPreventing pulm HTN during exercise
Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.
Sponsors
Cardioflow Technologies, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in respiratory rate at matched levels of exercise. | During the CPET, within 30 minutes of study. |
Secondary
| Measure | Time frame |
|---|---|
| Change in heart rate for given level of exercise (work rate in watts) | During the CPET, within 30 minutes of study. |
| Change in anaerobic 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 patient symptoms-- dyspnea and leg discomfort (Borg units) | During the CPET, within 30 minutes of study. |
| Change in ventilatory threshold | During the CPET, within 30 minutes of study. |
| Change in exercise time | 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. |
| Determining predictors of peak VO2 | 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 Peak VO2 | 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. |
Countries
United States
Contacts
Primary ContactDaniel W Kaiser, MD
Outcome results
None listed