Clinical trial NCT02984631: The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the IVC
Official title: The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the Interior Vena Cava
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension, Pulmonary
Heart Failure
Lead sponsor: Cardioflow Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2016-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Reduction in respiratory rate at matched levels of exercise.
timeFrame: During the CPET, within 30 minutes of study.
Secondary outcomes:
measure: Change in patient symptoms-- dyspnea and leg discomfort (Borg units)
timeFrame: During the CPET, within 30 minutes of study.
measure: Change in ventilatory threshold
timeFrame: During the CPET, within 30 minutes of study.
measure: Change in exercise time
timeFrame: During the CPET, within 30 minutes of study.
measure: Change in heart rate for given level of exercise (work rate in watts)
timeFrame: During the CPET, within 30 minutes of study.
measure: Change in anaerobic threshold
timeFrame: During the CPET, within 30 minutes of study.
measure: Change in pulmonary diastolic pressure for a given level of exercise (work rate)
timeFrame: During the CPET, within 30 minutes of study.
measure: Change in dead space ventilation at a given level of exercise (and VE/VCO2 slope)
timeFrame: During the CPET, within 30 minutes of study.
measure: Change in cardiac output at a given level of exercise
timeFrame: During the CPET, within 30 minutes of study.
measure: Determining predictors of peak VO2
timeFrame: During the CPET, within 30 minutes of study.
measure: Change in oxygen uptake at a given level of exercise
timeFrame: During the CPET, within 30 minutes of study.
measure: Change in pH level at a given level of exercise
timeFrame: During the CPET, within 30 minutes of study.
measure: Change in Peak VO2
timeFrame: During the CPET, within 30 minutes of study.
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
Study officials:
affiliation: Electrophysiologist at El Camino Hospital.
name: Daniel W Kaiser, MD
role: PRINCIPAL_INVESTIGATOR
References: