Heart FailureNCT03161158
PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure
A study testing CHIARA-System in people with Heart Failure and Acute Heart Failure, run by Fresenius Medical Care Deutschland GmbH at 11 sites in 2 countries.
Trial summary
This study evaluates whether tailored, peripheral ultrafiltration complementary to low-dose diuretics is associated with a reduction in cardiovascular mortality in 90 days after randomization and heart failure events in 90 days after discharge than usual care including stepped intravenous diuretics in acutely… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Heart Failure
- What is being tested?
- CHIARA-System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 3 Nov 2017to 26 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General:
- Informed consent signed and dated by study patient and investigator/authorised physician
- Minimum age of 18 years
- Ability to understand the nature and requirements of the study
- Study-specific:
- Heart failure patients with preserved, mid-range or reduced ejection fraction (confirmed according to the current definitions of heart failure with preserved (HFpEF), mid-range (HFmrEF) and reduced ejection fraction (HFrEF) requiring echocardiographic assessment within the prior 12 months) who are admitted to the hospital due to signs/symptoms of congestion (left- or right sided)
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- On regularly scheduled oral loop diuretics prior to admission
- Patients who have received IV loop diuretics for decongestion within 24 hours after hospital admission and prior to screening. The dosages are administered according to clinical judgment. (This inclusion criterion was changed with CIP amendment; in former version 3.0 it read "After pre-screening and prior to final screening for eligibility, patients who have received two boluses of IV loop diuretics (Dose according to the Furosemide-Low Intensification, Q12 hour bolus arm of the DOSE trial))
- Symptoms of congestion and clinical evidence at the time of final screening for eligibility:
- Fluid overload manifested by at least 2 of the following:
- Pitting edema ≥2+ of the lower extremities
- Jugular venous pressure >8 cm H2O
- Pulmonary congestion or pleural effusion on chest x-ray
- Paroxysmal nocturnal dyspnea or ≥2- pillow orthopnea
- Respiration rate ≥20 per minute
- Additional objective documentation of congestion: Lung or inferior vena cava ultrasound, chest x-ray or elevated filling pressures, if available, at the time of randomization (optional)
Who cannot join
- General:
- Any condition which could interfere with the patient's ability to comply with the study
- In case of female patients, pregnancy or lactation period
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- Unwillingness or inability to complete follow up
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- Active drug or alcohol abuse (smoking allowed)
- Study-specific:
- Acute coronary syndrome requiring intervention during index hospitalization
- Severe renal dysfunction requiring renal replacement therapy
- Systolic blood pressure < 90 mmHg at the time of randomization
- Pulmonary hypertension not secondary to left heart disease
- Pulmonary disease thought to be primarily responsible for symptoms
- Contraindication to systemic anticoagulation
- Severe concomitant disease expected to prolong hospitalization or to cause death in ≤ 90 days
- Sepsis
- Severe uncorrected valvular stenosis at the time of randomization
- Active myocarditis
- Hypertrophic obstructive cardiomyopathy
- Constrictive pericarditis or restrictive cardiomyopathy
- Liver cirrhosis due to primary liver disease* (*Restriction "due to primary liver disease" was present after amendment in study protocol version 5.0 but not in version 3.0)
- Known infection with human immunodeficiency virus (HIV) or active hepatitis C
- Previous solid organ transplant
- Presence or requirement for mechanical respiratory support
- Presence or requirement of a mechanical circulatory support device
- Need for IV positive inotropic agents at the time of randomization
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Germany6 sites
Universitätsklinikum Aachen (Med. Klinik II)
Aachen, 52074
Helios Klinikum Duisburg
Duisburg, 47166
Helios Klinikum Erfurt GmbH
Erfurt, 99089
Medizinische Universitätsklinik, Innere Medizin III
Heidelberg, 69120
Helios Klinikum Hildesheim GmbH
Hildesheim, 31135
Klinikum Stuttgart, Klinik für Nieren-, Hochdruck- und Autoimmunerkrankungen
Stuttgart, 70174
Sweden5 sites
Falun Hospital
Falun, 79182
Universitetssjukhuset Örebro, Hjärtsviktsmottagningen
Örebro, SE-70185
Danderyds University Hospital
Stockholm, 182 88
Karolinska University Hospital Huddinge, Department of Cardiology
Stockholm, SE-14186
Uppsala University Hospital, Department of Cardiology
Uppsala, SE-75185
About this study
This study evaluates whether tailored, peripheral ultrafiltration complementary to low-dose diuretics is associated with a reduction in cardiovascular mortality in 90 days after randomization and heart failure events in 90 days after discharge than usual care including stepped intravenous diuretics in acutely decompensated chronic heart failure with fluid overload (not fully responsive to diuretic therapy).
Read the detailed description
The study will evaluate whether stepped, peripheral ultrafiltration complementary to low-dose diuretics influences 90-day clinical outcomes compared to usual care including intravenous diuretics in symptomatic heart failure patients with persistent congestion. Hospitalized subjects will be randomly assigned to receive either a tailored, peripheral ultrafiltration approach complementary to intravenous low-dose diuretics and other guideline-directed medical therapy OR high-dose diuretic therapy and other Guideline-directed medical therapy.
- Conditions
- Heart Failure, Acute Heart Failure
- Being tested
- CHIARA-System, Usual care IV diuretics
- Keywords
- Cardio-Renal Syndrome type 1, Acutely decompensated chronic heart failure, Ultrafiltration
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHIARA-SystemDevice
Also called Low-dose IV diuretics
Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.
Usual care IV diureticsOther
Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)
| Study group | Role | What they receive |
|---|---|---|
| Ultrafiltration Group | Active comparator | Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. Receives: Device: CHIARA-System |
| Control group (Usual care IV diuretics) | Other | Guideline-directed therapy including IV loop diuretics according to treatment algorithm. Receives: Other: Usual care IV diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Failure (HF) Event
Heart failure hospitalization or unscheduled outpatient or emergency department treatment with IV loop diuretics or ultrafiltration.
Measured: in 90 days after discharge
Cardiovascular Death up to 90 Days After Randomization.
The rationale for the follow up time period of 90 days is that death rates reported in previous acute HF trials indicate that mortality seems to become linear after ~60-90 days post discharge Collection for Cardiovascular Trials initiative definition of cardiovascular death includes death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, and death due to other cardiovascular causes
Measured: in 90 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start3 Nov 2017
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Why it stopped: Low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, prospective, randomized, parallel-group, controlled
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Ruschitzka, Prof Dr med, Study chair, Universitätsspital Zürich, Klinik für Kardiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161158
- Sponsor's protocol ID
- UF-HF-02-INT
- Other IDs
- EUDAMED-No. CIV -17-01-018204
- Status last verified
- Jul 2020
- First submitted
- 2 May 2017
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Srivastava M, Harrison N, Caetano AFS, Tan AR, Law M. Ultrafiltration for acute heart failure. Cochrane Database Syst Rev. 2022 Jan 21;1(1):CD013593. doi: 10.1002/14651858.CD013593.pub2.
PubMed 35061249
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure
- ClinicalTrials.gov ID
- NCT03161158
- Acronym / sponsor ID
- UF-HF-02-INT
- Conditions
- Heart Failure, Acute Heart Failure
- Keywords
- Cardio-Renal Syndrome type 1, Acutely decompensated chronic heart failure, Ultrafiltration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 5 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether tailored, peripheral ultrafiltration complementary to low-dose diuretics is associated with a reduction in cardiovascular mortality in 90 days after randomization and heart failure events in 90 days after discharge than usual care including stepped intravenous diuretics in acutely decompensated chronic heart failure with fluid overload (not fully responsive to diuretic therapy).
Detailed description
The study will evaluate whether stepped, peripheral ultrafiltration complementary to low-dose diuretics influences 90-day clinical outcomes compared to usual care including intravenous diuretics in symptomatic heart failure patients with persistent congestion. Hospitalized subjects will be randomly assigned to receive either a tailored, peripheral ultrafiltration approach complementary to intravenous low-dose diuretics and other guideline-directed medical therapy OR high-dose diuretic therapy and other Guideline-directed medical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, prospective, randomized, parallel-group, controlled
| Arm | Type | Receives |
|---|---|---|
| Ultrafiltration Group | Active comparator | Device: CHIARA-SystemVeno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. |
| Control group (Usual care IV diuretics) | Other | Other: Usual care IV diureticsGuideline-directed therapy including IV loop diuretics according to treatment algorithm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Informed consent signed and dated by study patient and investigator/authorised physician
- Minimum age of 18 years
- Ability to understand the nature and requirements of the study
- Heart failure patients with preserved, mid-range or reduced ejection fraction (confirmed according to the current definitions of heart failure with preserved (HFpEF), mid-range (HFmrEF) and reduced ejection fraction (HFrEF) requiring echocardiographic assessment within the prior 12 months) who are admitted to the hospital due to signs/symptoms of congestion (left- or right sided)
- On regularly scheduled oral loop diuretics prior to admission
Key exclusion criteria (26 listed)
- Any condition which could interfere with the patient's ability to comply with the study
- In case of female patients, pregnancy or lactation period
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
- Unwillingness or inability to complete follow up
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 |
|---|---|---|
| CHIARA-SystemAlso: Low-dose IV diureticsTreatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days. | Device | Ultrafiltration Group |
| Usual care IV diureticsGuideline-directed therapy including IV loop diuretics (according to treatment algorithm) | Other | Control group (Usual care IV diuretics) |
Primary outcome
Heart Failure (HF) Event
Time frame: in 90 days after discharge
Heart failure hospitalization or unscheduled outpatient or emergency department treatment with IV loop diuretics or ultrafiltration.
Cardiovascular Death up to 90 Days After Randomization.
Time frame: in 90 days after discharge
The rationale for the follow up time period of 90 days is that death rates reported in previous acute HF trials indicate that mortality seems to become linear after ~60-90 days post discharge Collection for Cardiovascular Trials initiative definition of cardiovascular death includes death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, and death due to other cardiovascular causes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35061249Srivastava M, Harrison N, Caetano AFS, Tan AR, Law M. Ultrafiltration for acute heart failure. Cochrane Database Syst Rev. 2022 Jan 21;1(1):CD013593. doi: 10.1002/14651858.CD013593.pub2.
- Individual participant dataSharing planned: No
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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.
Frank Ruschitzka, Prof Dr med study chair
Universitätsspital Zürich, Klinik für Kardiologie
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHIARA-System in people with Heart Failure and Acute Heart Failure, run by Fresenius Medical Care Deutschland GmbH at 11 sites in 2 countries.
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 16 inclusion and 26 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: stopped early, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Sweden. 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?
Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Heart Failure (HF) Event (time frame: in 90 days after discharge). The study lists 2 primary outcomes in all. 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 NCT03161158, 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 5 May 2021.