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

Primary Purpose

Hypertension, Pulmonary, Heart Failure

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Preventing pulm HTN during exercise

About this trial

This is an interventional diagnostic trial for Hypertension, Pulmonary

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)
Participation in another clinical study (within 30 days)
Advanced neurological disease (e.g. dementia)

Sites / Locations

El Camino HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Preventing pulm HTN during exercise 2nd

Preventing pulm HTN during exercise 1st

Arm Description

Standard of care invasive cardiopulmonary exercise test (CPET) followed by CPET with pre-load control.

Pre-load control of invasive cardiopulmonary exercise test (CPET) followed by standard CPET.

Outcomes

Primary Outcome Measures

Reduction in respiratory rate at matched levels of exercise.

Secondary Outcome Measures

Change in patient symptoms-- dyspnea and leg discomfort (Borg units)

Change in ventilatory threshold

Change in exercise time

Change in heart rate for given level of exercise (work rate in watts)

Change in anaerobic threshold

Change in pulmonary diastolic pressure for a given level of exercise (work rate)

Change in dead space ventilation at a given level of exercise (and VE/VCO2 slope)

Change in cardiac output at a given level of exercise

Determining predictors of peak VO2

Change in oxygen uptake at a given level of exercise

Change in pH level at a given level of exercise

Change in Peak VO2

Full Information

NCT ID

NCT02984631

First Posted

December 3, 2016

Last Updated

April 5, 2018

Sponsor

Cardioflow Technologies, LLC

1. Study Identification

Unique Protocol Identification Number

NCT02984631

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (Actual)

Primary Completion Date

June 2019 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cardioflow Technologies, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Pulmonary, Heart Failure

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Preventing pulm HTN during exercise 2nd

Arm Type

Other

Arm Description

Standard of care invasive cardiopulmonary exercise test (CPET) followed by CPET with pre-load control.

Arm Title

Preventing pulm HTN during exercise 1st

Arm Type

Other

Arm Description

Pre-load control of invasive cardiopulmonary exercise test (CPET) followed by standard CPET.

Intervention Type

Procedure

Intervention Name(s)

Preventing pulm HTN during exercise

Intervention Description

Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.

Primary Outcome Measure Information:

Title

Reduction in respiratory rate at matched levels of exercise.

Time Frame