Heart DecompensationEarly Phase 1NCT00510601
Treating Congestive Heart Failure Using a Device to Remove Cholesterol
A Early Phase 1 study testing Kaneka Liposorber in people with Heart Decompensation, run by Patrick Moriarty, MD, FACP, FACC at 1 site in United States.
Trial summary
A pilot study to examine the effects of LDL-Apheresis on patients with Stage III Congestive Heart Failure. Study hypothesis: Decreased blood viscosity from receiving LDL-apheresis will decrease workload on the heart and improve symptoms associated with the progression of Congestive Heart Failure Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Decompensation
- What is being tested?
- Kaneka Liposorber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jul 2011
- Phase
- Early Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, between the age of 18 and 85 years old. If female, must guarantee that pregnancy will not occur for duration of study
- Presence of Left ventricular systolic dysfunction due to ischemic or non-ischemic cardiomyopathy and have symptoms of New York Heart Association Class III chronic Heart failure (CHF)
- Left ventricular ejection fraction (LVEF) ≤ 35% as measured by radionuclide angiography
- Subject must be on optimal conventional heart failure therapy including Beta-blocker in target or maximally tolerated doses for at least 3 months prior to entry into the study, and/or an angiotension receptor blocker (ARB) for at least 30 days prior to study entry. Subjects on ACE inhibitors, with approval of their physician, have been switched to an ARB one week before initiating apheresis
- Other optimal conventional therapy have been taken for at least 30 days prior to initiation of apheresis
- Subject is able to complete the 6-minute walk test and the Kansas City Congestive Heart Failure Quality of Life Questionnaire (KCCQ)
- Not currently in, or planning to participate in other studies
Who cannot join
- Age <18 years, or >85 years of age
- Poor venous access
- CHF due to, or associated with, uncorrected primary valvular disease, uncorrected thyroid disease, obstructive/hypertrophic cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, malfunctioning artificial heart valve, uncorrected congenital heart disease, or primary pulmonary hypertension
- Subject has undergone a cardiac revascularization, valvular surgery, or bi-ventricular resynchronization procedure within six months prior to initiation of apheresis treatment
- Subject is listed for transplantation and is expected to be transplanted within 6 months of initiation of apheresis treatment
- Subject has had a myocardial infarction within 6 months prior to initiation of apheresis treatment
Show all 27Show fewer
- Subject with electrocardiogram (ECG) recorded at initial screening showing particular abnormalities
- Subject has sustained VT, unless precipitated by an event such as an acute myocardial infarction, induction by catheter replacement, or by an electrophysiology procedure, or addressed by placement of an automatic implantable cardiac defibrillator (AICD)
- Subject has an AICD that has fired for any ventricular arrhythmia within 90 days of the initial visit
- Subject has unstable angina
- Subject on a mechanical assist device
- Subject has evidence of concomitant disease that may interfere with the natural course of the subjects underlying heart failure for the duration of the study
- Subject has poorly controlled diabetes mellitus
- Subject is currently taking study prohibited medication
- Subject is unable to tolerate Beta blocker therapy or asthma, has a heart rate of <55 bpm, or the presence of second or third degree heart block without an implanted pacemaker, and first-degree heart block with a PR interval > 220 milliseconds
- Subject has active disease, that in the opinion of the Investigator, may adversely affect the safety and efficacy of the treatment or the life span of the patient
- Subject has history of, or is currently abusing alcohol or illicit drugs
- Subject has serum potassium <4.0 mEq/L or >5.5mEq/L at initial visit
- Subject has serum digoxin level of >1.2ng/mL at time of initial visit
- Subject is pregnant or at risk of becoming pregnant during study
- Subject is currently lactating
- Subject has participated in a clinical drug or device trial in the last 90 days
- Subject has demonstrated noncompliance with previous medical regimens
- Subject is currently hospitalized, and is not hemodynamically stable, or has an acute cardiac or non-cardiac illness that requires further hospitalization
- Subject is unable, or unwilling to change from an ACEI to an ARB
- Subject has a known hypersensitivity to heparin or ethylene oxide
- Subject has a known Low-density lipoprotein cholesterol (LDL-C) level of >130mg/dl
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: LDL Apheresis for the Treatment of Congestive Heart Failure
A pilot study to examine the effects of LDL-Apheresis on patients with Stage III Congestive Heart Failure.
Study hypothesis: Decreased blood viscosity from receiving LDL-apheresis will decrease workload on the heart and improve symptoms associated with the progression of Congestive Heart Failure
Read the detailed description
Patients who qualify for the study will receive 7 bi-weekly LDL-Apheresis treatments with the Kaneka Liposorber device. Patients will assess their CHF symptoms using the KC Cardiomyopathy questionnaire prior to each treatment. Blood levels of certain indices related to CHF and safety profile labs will be drawn before and after the first and last treatment.
- Conditions
- Heart Decompensation
- Being tested
- Kaneka Liposorber
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaneka LiposorberDevice
Also called Liposorber LA-15 System (Kaneka, Osaka, Japan)
LDL-apheresis on a bi-weekly basis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Kaneka Liposorber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Symptoms score on KCCQ
Measured: 3 Months
Improved Ejection Fraction on ECHO
Measured: 3 Months
Improved distance during 6-minute walk test
Measured: 3 Months
Secondary outcomes (1)
Various lab measurements measured pre and post the 1st and last treatment, including blood viscosity
Measured: Approximately 2 hours, 3 months apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DecompensationStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Moriarty, MD, FACP, FACC
- Sponsor type
- University, hospital or other
- Collaborators
- Kaneka Medical America LLC
- Responsible party
- Sponsor-investigator, Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center
- Investigators
- Patrick Moriarty, M.D., Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510601
- Sponsor's protocol ID
- 10282
- Status last verified
- Jan 2016
- First submitted
- 31 Jul 2007
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LDL Apheresis for the Treatment of Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00510601
- Acronym / sponsor ID
- 10282
- Conditions
- Heart Decompensation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Patrick Moriarty, MD, FACP, FACCUniversity, hospital or other
- Collaborators
- Kaneka Medical America LLC
- Study start
- Jul 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Aug 2007 (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.
A pilot study to examine the effects of LDL-Apheresis on patients with Stage III Congestive Heart Failure.
Study hypothesis: Decreased blood viscosity from receiving LDL-apheresis will decrease workload on the heart and improve symptoms associated with the progression of Congestive Heart Failure
Detailed description
Patients who qualify for the study will receive 7 bi-weekly LDL-Apheresis treatments with the Kaneka Liposorber device. Patients will assess their CHF symptoms using the KC Cardiomyopathy questionnaire prior to each treatment. Blood levels of certain indices related to CHF and safety profile labs will be drawn before and after the first and last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Kaneka Liposorber |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female, between the age of 18 and 85 years old. If female, must guarantee that pregnancy will not occur for duration of study
- Presence of Left ventricular systolic dysfunction due to ischemic or non-ischemic cardiomyopathy and have symptoms of New York Heart Association Class III chronic Heart failure (CHF)
- Left ventricular ejection fraction (LVEF) ≤ 35% as measured by radionuclide angiography
- Subject must be on optimal conventional heart failure therapy including Beta-blocker in target or maximally tolerated doses for at least 3 months prior to entry into the study, and/or an angiotension receptor blocker (ARB) for at least 30 days prior to study entry. Subjects on ACE inhibitors, with approval of their physician, have been switched to an ARB one week before initiating apheresis
- Other optimal conventional therapy have been taken for at least 30 days prior to initiation of apheresis
Key exclusion criteria (27 listed)
- Age <18 years, or >85 years of age
- Poor venous access
- CHF due to, or associated with, uncorrected primary valvular disease, uncorrected thyroid disease, obstructive/hypertrophic cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, malfunctioning artificial heart valve, uncorrected congenital heart disease, or primary pulmonary hypertension
- Subject has undergone a cardiac revascularization, valvular surgery, or bi-ventricular resynchronization procedure within six months prior to initiation of apheresis treatment
- Subject is listed for transplantation and is expected to be transplanted within 6 months of initiation of apheresis treatment
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 |
|---|---|---|
| Kaneka LiposorberAlso: Liposorber LA-15 System (Kaneka, Osaka, Japan)LDL-apheresis on a bi-weekly basis | Device | 1 |
Primary outcome
Improved Symptoms score on KCCQ
Time frame: 3 Months
Improved Ejection Fraction on ECHO
Time frame: 3 Months
Improved distance during 6-minute walk test
Time frame: 3 Months
1 secondary outcome
Various lab measurements measured pre and post the 1st and last treatment, including blood viscosity
Time frame: Approximately 2 hours, 3 months apart
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
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Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients With Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement
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Association Between the Sit-To-Stand Test and the Prognosis of Patients With Heart Failure
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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.
Patrick Moriarty, M.D. principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Kaneka Liposorber in people with Heart Decompensation, run by Patrick Moriarty, MD, FACP, FACC 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 7 inclusion and 27 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: finished, as of the sponsor's last update on 13 Jan 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved Symptoms score on KCCQ (time frame: 3 Months). The study lists 3 primary outcomes in all. 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 13 Jan 2016.