Heart FailurePhase 4NCT00527059
Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
A Phase 4 study testing Levosimendan in addition to standard therapy and spironolactone, beta-blockers,ecc in people with Heart Failure and Renal Insufficiency, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the effect of levosimendan infusion, in addition to standard therapy,on renal function in patients with Acute Heart Failure,compared with standard therapy alone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Renal Insufficiency
- What is being tested?
- Levosimendan in addition to standard therapy and spironolactone, beta-blockers,ecc
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2007to Mar 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- an ejection fraction (EF) 40% by transthoracic echocardiogram,
- a baseline pulmonary capillary wedge pressure (PCWP) 20 mm Hg
- a MDRD (Modification of Diet Renal Disease) score > 30 and < 60
- and a standard therapy for HF that should include angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aldosterone blocking agents (spironolactone) and beta-blockers, unless contraindicated
Who cannot join
- patients receiving other oral or i.v. inotropes,
- oral or i.v. diuretics
- or receiving nitroglycerine or nitroprusside,
- patients with systolic blood pressure <110 mmHg,
- mechanical ventilation,
- anticipated survival <30 days,
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- absence of thoracic windows for echocardiography,
- acute coronary syndromes,
- sustained ventricular tachycardia or ventricular fibrillation,
- documented renal artery stenosis, requiring dialysis,
- requiring admission primarily for concurrent morbidity,
- severe aortic or mitral regurgitation,
- left ventricular failure primarily from uncorrected obstructive valvular disease, hypertrophic obstructive cardiomyopathy, restrictive/obstructive cardiomyopathy,
- uncorrected thyroid disease,
- known amyloid cardiomyopathy
- or known malfunctioning artificial heart valve.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza
Rome, Viale Del Policlinico 155, 00161
About this study
The purpose of this study is to evaluate the effect of levosimendan infusion, in addition to standard therapy,on renal function in patients with Acute Heart Failure,compared with standard therapy alone.
Read the detailed description
The term "cardiorenal syndrome" has been applied to the presence or development of a renal dysfunction in HF patients and may be the major precipitant of decompensation and cause for admission in these patients. The renal hypoperfusion that occurs with cardiac injury can lead to sodium and water retention and activation of the renin-angiotensin-aldosterone system and neurohormonal pathways with resultant deleterious effects on the myocardium. A vicious cycle may then ensue and be associated with increased cardiovascular complications. In this regard, renal dysfunction is of a functional nature and thus means to intervene with this vicious cycle need to be sought.
Several studies already demonstrated the deleterious effects of renal dysfunction on prognosis in patients with HF due to chronic left ventricular dysfunction.
Levosimendan increases myocardial contractility without significant changes in the intracellular calcium ion and cyclic adenosine monophosphate concentrations and does not enhance myocardial oxygen demand. By its action on the potassium channels this drug also dilates the coronary and peripheral arteries and exerts an anti-ischemic,anti-stunning effect. To date, the effects of levosimendan on renal function in patients with worsening chronic HF, remain unknown.
- Conditions
- Heart Failure, Renal Insufficiency
- Being tested
- Levosimendan in addition to standard therapy, spironolactone, beta-blockers,ecc
- Keywords
- Cardiorenal syndrome
- Medical subject headings
- Heart Failure, Renal Insufficiency, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levosimendan in addition to standard therapyDrug
intravenous infusion of levosimendan (10 minutes bolus with 6 mcg/Kg according to physician judgement, followed by 0.1 mcg/Kg/min for 24 hours) in addition to standard therapy
spironolactone, beta-blockers,eccDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients with acute heart failure Receives: Drug: Levosimendan in addition to standard therapy |
| 2 | Active comparator | standard therapy for heart failure Receives: Drug: spironolactone, beta-blockers,ecc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: GFR measured by inulin Clearance.
Measured: 0, 24. 48 and 72 hours after Levosimendan infusion starting
Secondary outcomes (1)
Secondary endpoints: •Other renal function measures: BUN, albumin, urine volume, sodium excretion and plasma sodium, and cystatin. •Hemodynamic parameters: PCWP, PAP, cardiac output, HR, BP, renal blood flow.
Measured: 0,1,24,48 and 72 hours after Levosimendan infusion started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2007
- Study completionMar 2008 (estimated)
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Investigators
- Francesco Fedele, professor, Principal investigator, Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527059
- Sponsor's protocol ID
- LEV1068
- Status last verified
- Sep 2007
- First submitted
- 7 Sep 2007
- Last updated
- 10 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Fedele F, Bruno N, Brasolin B, Caira C, D'Ambrosi A, Mancone M. Levosimendan improves renal function in acute decompensated heart failure: possible underlying mechanisms. Eur J Heart Fail. 2014 Mar;16(3):281-8. doi: 10.1002/ejhf.9. Epub 2013 Dec 11.
PubMed 24464960
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT00527059
- Acronym / sponsor ID
- LEV1068
- Conditions
- Heart Failure, Renal Insufficiency
- Keywords
- Cardiorenal syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Mar 2008 (estimated)
- First posted
- 10 Sep 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.
The purpose of this study is to evaluate the effect of levosimendan infusion, in addition to standard therapy,on renal function in patients with Acute Heart Failure,compared with standard therapy alone.
Detailed description
The term "cardiorenal syndrome" has been applied to the presence or development of a renal dysfunction in HF patients and may be the major precipitant of decompensation and cause for admission in these patients. The renal hypoperfusion that occurs with cardiac injury can lead to sodium and water retention and activation of the renin-angiotensin-aldosterone system and neurohormonal pathways with resultant deleterious effects on the myocardium. A vicious cycle may then ensue and be associated with increased cardiovascular complications. In this regard, renal dysfunction is of a functional nature and thus means to intervene with this vicious cycle need to be sought.
Several studies already demonstrated the deleterious effects of renal dysfunction on prognosis in patients with HF due to chronic left ventricular dysfunction.
Levosimendan increases myocardial contractility without significant changes in the intracellular calcium ion and cyclic adenosine monophosphate concentrations and does not enhance myocardial oxygen demand. By its action on the potassium channels this drug also dilates the coronary and peripheral arteries and exerts an anti-ischemic,anti-stunning effect. To date, the effects of levosimendan on renal function in patients with worsening chronic HF, remain unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levosimendan in addition to standard therapypatients with acute heart failure |
| 2 | Active comparator | Drug: spironolactone, beta-blockers,eccstandard therapy for heart failure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- an ejection fraction (EF) 40% by transthoracic echocardiogram,
- a baseline pulmonary capillary wedge pressure (PCWP) 20 mm Hg
- a MDRD (Modification of Diet Renal Disease) score > 30 and < 60
- and a standard therapy for HF that should include angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aldosterone blocking agents (spironolactone) and beta-blockers, unless contraindicated
Key exclusion criteria (16 listed)
- patients receiving other oral or i.v. inotropes,
- oral or i.v. diuretics
- or receiving nitroglycerine or nitroprusside,
- patients with systolic blood pressure <110 mmHg,
- mechanical ventilation,
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 |
|---|---|---|
| Levosimendan in addition to standard therapyintravenous infusion of levosimendan (10 minutes bolus with 6 mcg/Kg according to physician judgement, followed by 0.1 mcg/Kg/min for 24 hours) in addition to standard therapy | Drug | 1 |
| spironolactone, beta-blockers,ecc | Drug | 2 |
Primary outcome
Primary endpoint: GFR measured by inulin Clearance.
Time frame: 0, 24. 48 and 72 hours after Levosimendan infusion starting
1 secondary outcome
Secondary endpoints: •Other renal function measures: BUN, albumin, urine volume, sodium excretion and plasma sodium, and cystatin. •Hemodynamic parameters: PCWP, PAP, cardiac output, HR, BP, renal blood flow.
Time frame: 0,1,24,48 and 72 hours after Levosimendan infusion started
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2007.
- Derived from this study: PubMed 24464960Fedele F, Bruno N, Brasolin B, Caira C, D'Ambrosi A, Mancone M. Levosimendan improves renal function in acute decompensated heart failure: possible underlying mechanisms. Eur J Heart Fail. 2014 Mar;16(3):281-8. doi: 10.1002/ejhf.9. Epub 2013 Dec 11.
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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.
Francesco Fedele, professor principal investigator
Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza
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 Levosimendan in addition to standard therapy and spironolactone, beta-blockers,ecc in people with Heart Failure and Renal Insufficiency, run by University of Roma La Sapienza 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 4 inclusion and 16 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 10 Sep 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Fedele, professor (0039-0649979020, francesco.fedele@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint: GFR measured by inulin Clearance. (time frame: 0, 24. 48 and 72 hours after Levosimendan infusion starting). 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 NCT00527059, 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 10 Sep 2007.