Hypertension, PulmonaryNCT02984631
The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the IVC
A study testing Preventing pulm HTN during exercise in people with Hypertension, Pulmonary and Heart Failure, run by Cardioflow Technologies, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Pulmonary, Heart Failure
- What is being tested?
- Preventing pulm HTN during exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Daniel W Kaiser, MD contact
United States1 site, 1 recruiting
- Recruiting
El Camino Hospital
Mountain View, California, 94040
Ryan Schroeder
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Pulmonary, Heart Failure
- Being tested
- Preventing pulm HTN during exercise
- Medical subject headings
- Hypertension, Pulmonary, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventing pulm HTN during exerciseProcedure or surgery
Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.
| Study group | Role | What they receive |
|---|---|---|
| Preventing pulm HTN during exercise 2nd | Other | Standard of care invasive cardiopulmonary exercise test (CPET) followed by CPET with pre-load control. Receives: Procedure: Preventing pulm HTN during exercise |
| Preventing pulm HTN during exercise 1st | Other | Pre-load control of invasive cardiopulmonary exercise test (CPET) followed by standard CPET. Receives: Procedure: Preventing pulm HTN during exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in respiratory rate at matched levels of exercise.
Measured: During the CPET, within 30 minutes of study.
Secondary outcomes (12)
Change in patient symptoms-- dyspnea and leg discomfort (Borg units)
Measured: During the CPET, within 30 minutes of study.
Change in ventilatory threshold
Measured: During the CPET, within 30 minutes of study.
Change in exercise time
Measured: During the CPET, within 30 minutes of study.
Change in heart rate for given level of exercise (work rate in watts)
Measured: During the CPET, within 30 minutes of study.
Change in anaerobic threshold
Measured: During the CPET, within 30 minutes of study.
Change in pulmonary diastolic pressure for a given level of exercise (work rate)
Measured: During the CPET, within 30 minutes of study.
Change in dead space ventilation at a given level of exercise (and VE/VCO2 slope)
Measured: During the CPET, within 30 minutes of study.
Change in cardiac output at a given level of exercise
Measured: During the CPET, within 30 minutes of study.
Determining predictors of peak VO2
Measured: During the CPET, within 30 minutes of study.
Change in oxygen uptake at a given level of exercise
Measured: During the CPET, within 30 minutes of study.
Change in pH level at a given level of exercise
Measured: During the CPET, within 30 minutes of study.
Change in Peak VO2
Measured: During the CPET, within 30 minutes of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardioflow Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel W Kaiser, MD, Principal investigator, Electrophysiologist at El Camino Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984631
- Sponsor's protocol ID
- CFT-37215-ECH-02
- Status last verified
- Apr 2018
- First submitted
- 3 Dec 2016
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the Interior Vena Cava
- ClinicalTrials.gov ID
- NCT02984631
- Acronym / sponsor ID
- CFT-37215-ECH-02
- Conditions
- Hypertension, Pulmonary, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cardioflow Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventing pulm HTN during exercise 2nd | Other | Procedure: Preventing pulm HTN during exerciseStandard of care invasive cardiopulmonary exercise test (CPET) followed by CPET with pre-load control. |
| Preventing pulm HTN during exercise 1st | Other | Procedure: Preventing pulm HTN during exercisePre-load control of invasive cardiopulmonary exercise test (CPET) followed by standard CPET. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventing pulm HTN during exerciseBalloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise. | Procedure or surgery | Preventing pulm HTN during exercise 1st, Preventing pulm HTN during exercise 2nd |
Primary outcome
Reduction in respiratory rate at matched levels of exercise.
Time frame: During the CPET, within 30 minutes of study.
12 secondary outcomes
Change in patient symptoms-- dyspnea and leg discomfort (Borg units)
Time frame: During the CPET, within 30 minutes of study.
Change in ventilatory threshold
Time frame: During the CPET, within 30 minutes of study.
Change in exercise time
Time frame: During the CPET, within 30 minutes of study.
Change in heart rate for given level of exercise (work rate in watts)
Time frame: During the CPET, within 30 minutes of study.
Change in anaerobic threshold
Time frame: During the CPET, within 30 minutes of study.
Change in pulmonary diastolic pressure for a given level of exercise (work rate)
Time frame: During the CPET, within 30 minutes of study.
Change in dead space ventilation at a given level of exercise (and VE/VCO2 slope)
Time frame: During the CPET, within 30 minutes of study.
Change in cardiac output at a given level of exercise
Time frame: During the CPET, within 30 minutes of study.
Determining predictors of peak VO2
Time frame: During the CPET, within 30 minutes of study.
Change in oxygen uptake at a given level of exercise
Time frame: During the CPET, within 30 minutes of study.
Change in pH level at a given level of exercise
Time frame: During the CPET, within 30 minutes of study.
Change in Peak VO2
Time frame: During the CPET, within 30 minutes of study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel W Kaiser, MD contact
Daniel W Kaiser, MD principal investigator
Electrophysiologist at El Camino Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventing pulm HTN during exercise in people with Hypertension, Pulmonary and Heart Failure, run by Cardioflow Technologies, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel W Kaiser, MD (danielkaisermd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in respiratory rate at matched levels of exercise. (time frame: During the CPET, within 30 minutes of study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.