The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the IVC

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Hypertension, Pulmonary
• Intervention / Treatment: Procedure: Preventing pulm HTN 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel W Kaiser, MD; Email: danielkaisermd@gmail.com

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • Recruiting
      • El Camino Hospital
      • Contact: Ryan Schroeder

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Preventing pulm HTN during exercise 2nd; Standard of care invasive cardiopulmonary exercise test (CPET) followed by CPET with pre-load control.	Procedure: Preventing pulm HTN during exercise; Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.
Other: Preventing pulm HTN during exercise 1st; Pre-load control of invasive cardiopulmonary exercise test (CPET) followed by standard CPET.	Procedure: Preventing pulm HTN during exercise; Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in respiratory rate at matched levels of exercise.	During the CPET, within 30 minutes of study.

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 dead space ventilation at a given level of exercise (and VE/VCO2 slope)	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.

Collaborators and Investigators

• Sponsor: Cardioflow Technologies, LLC
• Investigators: Principal Investigator: Daniel W Kaiser, MD, Electrophysiologist at El Camino Hospital.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: December 3, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: CFT-37215-ECH-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No