Severe Congestive Heart FailurePhase 4NCT00360958
Treatment of Severe Heart Failure by Ultrafiltration
A Phase 4 study testing ultrafiltration in people with Severe Congestive Heart Failure, run by Centro Cardiologico Monzino at 1 site in Italy.
Trial summary
Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Severe Congestive Heart Failure
- What is being tested?
- ultrafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2006to Dec 2012
- Phase
- Phase 4
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe heart failure (NYHA III-IV) with fluid overload
- Ejection fraction < 40%
- Estimated fluid overload > 4 kg
Who cannot join
- Severe renal insufficiency
- Acute pulmonary edema and/or cardiogenic shock
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure
Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment.
Read the detailed description
Patients with severe heart failure (New York Heart Association [NYHA] III-IV) and fluid overload will be randomized to ultrafiltration (UF group) or conventional medical treatment (Control group). Patients follow-up at least monthly visit for one year. Ultrafiltration will be repeated during follow-up in case of body weight gain due to fluid accumulation. Ultrafiltration will be performed during short term hospitalization.
- Conditions
- Severe Congestive Heart Failure
- Being tested
- ultrafiltration
- Keywords
- ultrafiltration, heart failure, fluid overload
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrafiltrationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ultrafiltration | Experimental | Ultrafiltration treatment Receives: Procedure: ultrafiltration |
| Usual treatment | Active comparator | Usual HF treatment Receives: Procedure: ultrafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of hospitalizations for heart failure
Measured: End of study
Secondary outcomes (1)
long term major adverse clinical events including death
Measured: End 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 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Congestive 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piergiuseppe Agostoni, Centro Cardiologico Monzino
- Investigators
- Piergiuseppe Agostoni, MD.PhD, Principal investigator, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360958
- Sponsor's protocol ID
- CCM S67/306
- Status last verified
- Jan 2016
- First submitted
- 3 Aug 2006
- Last updated
- 28 Jan 2016
- Results posted
- No
Publications
Marenzi G, Muratori M, Cosentino ER, Rinaldi ER, Donghi V, Milazzo V, Ferramosca E, Borghi C, Santoro A, Agostoni P. Continuous ultrafiltration for congestive heart failure: the CUORE trial. J Card Fail. 2014 Jan;20(1):9-17. doi: 10.1016/j.cardfail.2013.11.004. Epub 2013 Nov 20.
PubMed 24269855
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00360958
- Acronym / sponsor ID
- CCM S67/306
- Conditions
- Severe Congestive Heart Failure
- Keywords
- ultrafiltration, heart failure, fluid overload
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Aug 2006 (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.
Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment.
Detailed description
Patients with severe heart failure (New York Heart Association [NYHA] III-IV) and fluid overload will be randomized to ultrafiltration (UF group) or conventional medical treatment (Control group). Patients follow-up at least monthly visit for one year. Ultrafiltration will be repeated during follow-up in case of body weight gain due to fluid accumulation. Ultrafiltration will be performed during short term hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrafiltration | Experimental | Procedure: ultrafiltrationUltrafiltration treatment |
| Usual treatment | Active comparator | Procedure: ultrafiltrationUsual HF treatment |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe heart failure (NYHA III-IV) with fluid overload
- Ejection fraction < 40%
- Estimated fluid overload > 4 kg
Key exclusion criteria (2 listed)
- Severe renal insufficiency
- Acute pulmonary edema and/or cardiogenic shock
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 |
|---|---|---|
| ultrafiltration | Procedure or surgery | Ultrafiltration, Usual treatment |
Primary outcome
number of hospitalizations for heart failure
Time frame: End of study
1 secondary outcome
long term major adverse clinical events including death
Time frame: End of study
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 28 Jan 2016.
- Derived from this study: PubMed 24269855Marenzi G, Muratori M, Cosentino ER, Rinaldi ER, Donghi V, Milazzo V, Ferramosca E, Borghi C, Santoro A, Agostoni P. Continuous ultrafiltration for congestive heart failure: the CUORE trial. J Card Fail. 2014 Jan;20(1):9-17. doi: 10.1016/j.cardfail.2013.11.004. Epub 2013 Nov 20.
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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.
Piergiuseppe Agostoni, MD.PhD principal investigator
Centro Cardiologico Monzino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ultrafiltration in people with Severe Congestive Heart Failure, run by Centro Cardiologico Monzino at 1 site in Italy.
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 3 inclusion and 2 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 28 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 Italy. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
number of hospitalizations for heart failure (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00360958, which also lists 1 linked publication.
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 28 Jan 2016.