Heart FailureNCT04338503
Mechanically Optimizing Cardiac Preload in Heart Failure Patients
An observational study of Heart Failure, run by Cardioflow Technologies, LLC at 1 site in United States.
Trial summary
The purpose of the current study is to determine if partial balloon occlusion of the inferior vena cava can optimize cardiac pre-load and subsequently pulmonary pressures and cardiac output as a novel method to unload pulmonary edema and other symptoms of decompensated congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Partial IVC occlusion
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 30 Jun 2024
- Phase
- Observational
- 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
Study population: Decompensated congestive heart failure patients referred for right heart catheterization.
Who may be able to join
- Subjects scheduled to undergo a right heart catheterization at Saint Thomas Hospital.
- New York Heart Association (NYHA) II or III.
- Subjects must be last least 18 years of age.
- A left ventricular ejection fraction >= 20%.
- Pulmonary artery occlusion pressure, or pulmonary wedge pressure >20 mmHg.
Who cannot join
- Subjects without sinus rhythm.
- Evidence of right heart failure.
- Patients with primary pulmonary hypertension
- Pulmonary wedge pressure <15mmHg.
- Significant lung disease, such as prior diagnosis of COPD.
- Resting or dynamic outflow tract gradient
- Patients with left bundle branch block
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Saint Thomas Heart
Nashville, Tennessee, 37205
Lynn Peterson, 615-222-4504, speterso@ascension.org
About this study
Official title: Mechanically Optimizing Cardiac Preload Using Partial Inferior Vena Cava Occlusion to Reduce Pulmonary Pressures in Heart Failure Patients in Heart Failure Patients
The purpose of the current study is to determine if partial balloon occlusion of the inferior vena cava can optimize cardiac pre-load and subsequently pulmonary pressures and cardiac output as a novel method to unload pulmonary edema and other symptoms of decompensated congestive heart failure. All products in this study are FDA approved and adhere to the specifications of the intended use.
- Conditions
- Heart Failure
- Being tested
- Partial IVC occlusion
- Keywords
- pulmonary edema, preload
- Medical subject headings
- Heart Failure, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial IVC occlusionDiagnostic test
Partial balloon occlusion of the inferior vena cava.
| Study group | Role | What they receive |
|---|---|---|
| HF patients | Decompensated heart failure patients undergoing right heart catheterization. Receives: Diagnostic Test: Partial IVC occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary arterial pressures
Change in the measured mean pulmonary arterial pressure
Measured: During partial balloon occlusion
Secondary outcomes (1)
Change in cardiac output
Change in cardiac output measured in liters per minute
Measured: During partial balloon occlusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start1 Sep 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardioflow Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Saint Thomas Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338503
- Sponsor's protocol ID
- CFT-37215-STH-01
- Status last verified
- Mar 2023
- First submitted
- 5 Apr 2020
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanically Optimizing Cardiac Preload Using Partial Inferior Vena Cava Occlusion to Reduce Pulmonary Pressures in Heart Failure Patients in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT04338503
- Acronym / sponsor ID
- CFT-37215-STH-01
- Conditions
- Heart Failure
- Keywords
- pulmonary edema, preload
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cardioflow Technologies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Saint Thomas Health
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 Apr 2020 (actual)
- 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.
The purpose of the current study is to determine if partial balloon occlusion of the inferior vena cava can optimize cardiac pre-load and subsequently pulmonary pressures and cardiac output as a novel method to unload pulmonary edema and other symptoms of decompensated congestive heart failure. All products in this study are FDA approved and adhere to the specifications of the intended use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF patients | – | Diagnostic Test: Partial IVC occlusionDecompensated heart failure patients undergoing right heart catheterization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Decompensated congestive heart failure patients referred for right heart catheterization.
Key inclusion criteria (5 listed)
- Subjects scheduled to undergo a right heart catheterization at Saint Thomas Hospital.
- New York Heart Association (NYHA) II or III.
- Subjects must be last least 18 years of age.
- A left ventricular ejection fraction >= 20%.
- Pulmonary artery occlusion pressure, or pulmonary wedge pressure >20 mmHg.
Key exclusion criteria (7 listed)
- Subjects without sinus rhythm.
- Evidence of right heart failure.
- Patients with primary pulmonary hypertension
- Pulmonary wedge pressure <15mmHg.
- Significant lung disease, such as prior diagnosis of COPD.
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 |
|---|---|---|
| Partial IVC occlusionPartial balloon occlusion of the inferior vena cava. | Diagnostic test | HF patients |
Primary outcome
Change in pulmonary arterial pressures
Time frame: During partial balloon occlusion
Change in the measured mean pulmonary arterial pressure
1 secondary outcome
Change in cardiac output
Time frame: During partial balloon occlusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 inclusion and 7 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 30 Mar 2023. 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 (6154152586, dan@cardioflowtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary arterial pressures (time frame: During partial balloon occlusion). 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 30 Mar 2023.