Heart FailurePhase 2HORIZON-HFNCT00616161
A Phase II Trial to Assess Hemodynamic Effects of Istaroxime in Pts With Worsening HF and Reduced LV Systolic Function
A Phase 2 study testing Istaroxime in people with Heart Failure, run by sigma-tau i.f.r. S.p.A..
Trial summary
The purpose of this study is to determine the minimum effective dose of Istaroxime, in patients requiring hospitalization for deterioration of chronic heart failure and left ventricular systolic dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Istaroxime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Aug 2007
- Phase
- Phase 2
- 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
- Signing of a written informed consent form.
- Male or female patients aged between 18 and 85 years.
- Negative pregnancy test at screening, for women of childbearing potential.
- Body weight less or equal to 100 kg.
- Blood pressure not more than SAP=150 or DAP=90 mmHg.
- Heart rate in the range of 60-110 bpm
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- Adequate Echo window available.
- Hospital admission to a monitored bed with a primary diagnosis of worsening of heart failure and LV Ejection Fraction less or equal to 35% documented by 2D-Echocardiogram, or radionuclide angiography or LV angiogram within 6 months prior to screening or at hospitalization.
- the clinical condition of the patient are stabilized within 48 hours from hospitalization and do not require continuous iv drug treatments
- no need for additional new oral treatments or any intravenous treatment administration over the following 8 hours is foreseen
- Randomisation period inclusion criteria:
- Any residual sign of heart failure (e.g.: Jugular Venous Distension, and/or Rales and/or Peripheral Oedema) associated with a PCWP more or equal to 20 mmHg,
- The last three consecutive determinations of PCWP, obtained during the stabilization period, have to be in a maximum range of variability of 10%.
Who cannot join
- Ongoing treatment with oral or intravenous inotropes and/or inodilators.
- Patient treated with digoxin within the last week, can be randomised if the plasma concentration of digoxin are tested before randomisation and its value will be less than 0.5 ng/ml.
- Intermittent inotropes administration within 2 weeks.
- Symptoms of Heart Failure at randomization e.g.: dyspnoea
- Systolic blood pressure < 90 mmHg.
- Atrial fibrillation within 2 weeks.
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- Left Ventricular Bundle Branch Block
- Cardiogenic shock or mechanical ventilation.
- Creatinine level > 3.0 mg/dl or requiring dialysis treatment.
- Left ventricular failure primarily from uncorrected obstructive valvular disease, hypertrophic obstructive cardiomyopathy, restrictive/obstructive cardiomyopathy, uncorrected thyroid disease, known acute myocarditis, known amyloid cardiomyopathy.
- Artificial heart valve.
- Electrical device implanted (ICD, CRT)
- Evidence of acute coronary syndrome within 3 months.
- History of stroke or transient ischemic attack in the 6 months prior to screening.
- History of sustained ventricular tachycardia.
- Coronary by-pass grafting or PTCA within the last 30 days
- INR > 1.5.
- Status post successful cardiac resuscitation.
- Serum K < 3.5 mEq/l or > 5.3 mEq/l just prior to treatment.
- ALT, AST > 3 times the upper normal limit just prior to treatment.
- Hemoglobin < 10 g/dl (either gender) just prior to treatment.
- Other clinically significant laboratory or medical conditions, which in the opinion of the Investigator make the patient unsuitable for evaluation in the study.
- Anticipated survival of less than 2 months for concomitant diseases.
About this study
Official title: A Phase II Study to Assess the Hemodynamic Effects of Istaroxime, a Novel Lusinotropic Agent, in Patients Hospitalized With Worsening Heart Failure and a Reduced Left Ventricular Systolic Function
The purpose of this study is to determine the minimum effective dose of Istaroxime, in patients requiring hospitalization for deterioration of chronic heart failure and left ventricular systolic dysfunction. This goal will be reached by comparing the hemodynamic effect of three different doses of the drug versus placebo. Efficacy will be measured as a change in Pulmonary Capillary Wedge Pressure from pre-infusion to the last assessment at six hours intravenous infusion.Secondary objectives will be to evaluate safety, tolerability and efficacy on other main hemodynamic parameters, echocardiographic and echo-doppler measurements, plus preliminary pharmacokinetics of the drug.
Read the detailed description
Congestive heart failure is one of the most common cardiovascular conditions and it is presently reaching epidemic proportions. The prevalence of chronic heart failure has risen specifically as a result of the increased longevity and longer survival after myocardial infarction. In 2003, over one million hospitalization with a primary diagnosis of heart failure occurred in the United States of America, and a similar number has been reported in Europe, too. At present, approximately 5 million Americans are estimated to suffer of this syndrome and the number is expected to continue to increase with the increase and aging of the population. Despite advances in treatment, the mortality remains high in U.S.A. as in Europe, with nearly three hundred thousands patients dying of CHF as the primary or contributory cause each year.
The total number of hospital admissions approaches 3 million yearly when HF is listed as a primary or secondary diagnosis. Although these patients have a relatively low mortality during the hospitalization (less than 4%), the readmission rates within 60 days of discharge range from 20 to 30% and mortality within 60 days of discharge is 5 - 10%.
The primary aim of acute treatment of worsening CHF is to alleviate the symptoms of congestion and edema, improve the hemodynamic profile, and preserve renal function without causing myocardial injury. Improved hemodynamics usually results in relief of primary symptoms like dyspnea and edema and in a consequent improved sense of wellbeing and mental status. The improvement in hemodynamics may persist after the pharmacological interventions used in the acute phase are withdrawn.
The need in this setting is to decrease the filling pressures (RA pressure and PCWP), increase cardiac output, without increasing the heart rate and inducing/worsening atrial or ventricular arrhythmias. In addition, the agent should improve diastolic function, modulate the exaggerated neurohormonal responses to CHF and preserve/protect the viable but non contractile myocardium (e.g.: the hibernated myocardium). The agent should also facilitate the earlier start of life-saving therapies (e.g. beta - blockers).Pre-clinical data on Istaroxime show that this drug increases contractility without increasing heart rate and oxygen consumption; furthermore it is improving diastolic dysfunction and it not causing vasodilatation.
- Conditions
- Heart Failure
- Being tested
- Istaroxime, Placebo
- Keywords
- Acute Heart Failure, Inotropes, Lusitropic agents, Istaroxime, PST2744
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IstaroximeDrug
Also called PST2744
0.5 microgram/kg/min IV for 6 hours
IstaroximeDrug
Also called PST2744
1.0 microgram/kg/min IV for 6 hours
IstaroximeDrug
Also called PST2744
1.5 microgram/kg/min IV for 6 hours
PlaceboDrug
Also called placebo of PST2744
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Istaroxime dose of 0.5 microgram/kg body weight/minute of iv infusion for six ours Receives: Drug: Istaroxime |
| 2 | Experimental | Istaroxime dose of 1.0 microgram/kg body weight/minute of iv infusion for six ours Receives: Drug: Istaroxime |
| 3 | Experimental | Istaroxime dose of 1.5 microgram/kg body weight/minute of iv infusion for six ours Receives: Drug: Istaroxime |
| 4 | Placebo comparator | Placebo iv infusion for six ours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the minimum effective dose of ISTAROXIME by comparing the hemodynamic effect of 3 different doses of the drug versus placebo. Efficacy will be measured as a change in PCWP from right heart catheterization.
Measured: 6 hours drug infusion
Secondary outcomes (1)
safety, tolerability and efficacy on blood pressure, heart rate, cardiac index, stroke work index, right atrial pressure, systemic and pulmonary vascular resistances, Echocardiographic and Doppler parameters, neurohormonal parameters and renal function.
Measured: 6 and 24 hours after start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startAug 2006
- Primary completionJul 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- sigma-tau i.f.r. S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDS Pharma Services
- Investigators
- Mihai Gheorghiade, MD FACC, Study chair, Northwestern University Feinberg School of Medicine - ChicagoWitold Ruzyllo, MD, Principal investigator, National Institute of Cardiology, Department of Coronary Artery Disease - Warsaw - POLANDCezar Macarie, MD, Principal investigator, Insitutul de Boli Cardiovasculare C.C. Iliescu Bucuresti, Bucharest - ROMANIADimitrios Th Kremastinos, MD, Principal investigator, Second Cardiology Department, Athens University Medical School, University Hospital Attikon, Athens - GREECESerban I Bubenek-Turconi, MD, Principal investigator, First Anaesth. & Intensive Care Dept., CC Iliescu Heart Disease Institute, Bucharest - ROMANIAMaria Dorobantu, MD, Principal investigator, Emergency Hospital "Loreasca", Bucharest - ROMANIAJerzy Korewicki, MD, Principal investigator, National Institute of Cardiology, Warsaw, PolandJaroslaw Drodz, MD, Principal investigator, Hospital bieganskieko , Dept of Cardiology, Lodz - POLAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616161
- Sponsor's protocol ID
- PST2744-DM-04-012
- Acronym
- HORIZON-HF
- Status last verified
- Feb 2008
- First submitted
- 5 Feb 2008
- Last updated
- 15 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gheorghiade M, Sabbah HN. Istaroxime: an investigational luso-inotropic agent for acute heart failure syndromes. Am J Cardiol. 2007 Jan 22;99(2A):1A-3A. doi: 10.1016/j.amjcard.2006.09.001. Epub 2006 Sep 18. No abstract available.
PubMed 17239700Micheletti R, Palazzo F, Barassi P, Giacalone G, Ferrandi M, Schiavone A, Moro B, Parodi O, Ferrari P, Bianchi G. Istaroxime, a stimulator of sarcoplasmic reticulum calcium adenosine triphosphatase isoform 2a activity, as a novel therapeutic approach to heart failure. Am J Cardiol. 2007 Jan 22;99(2A):24A-32A. doi: 10.1016/j.amjcard.2006.09.003. Epub 2006 Sep 25.
PubMed 17239701Mattera GG, Lo Giudice P, Loi FM, Vanoli E, Gagnol JP, Borsini F, Carminati P. Istaroxime: a new luso-inotropic agent for heart failure. Am J Cardiol. 2007 Jan 22;99(2A):33A-40A. doi: 10.1016/j.amjcard.2006.09.004. Epub 2006 Sep 18.
PubMed 17239702Sabbah HN, Imai M, Cowart D, Amato A, Carminati P, Gheorghiade M. Hemodynamic properties of a new-generation positive luso-inotropic agent for the acute treatment of advanced heart failure. Am J Cardiol. 2007 Jan 22;99(2A):41A-46A. doi: 10.1016/j.amjcard.2006.09.005. Epub 2006 Sep 18.
PubMed 17239704Ghali JK, Smith WB, Torre-Amione G, Haynos W, Rayburn BK, Amato A, Zhang D, Cowart D, Valentini G, Carminati P, Gheorghiade M. A phase 1-2 dose-escalating study evaluating the safety and tolerability of istaroxime and specific effects on electrocardiographic and hemodynamic parameters in patients with chronic heart failure with reduced systolic function. Am J Cardiol. 2007 Jan 22;99(2A):47A-56A. doi: 10.1016/j.amjcard.2006.09.006. Epub 2006 Sep 20.
PubMed 17239705Wehrens XH. Istaroxime, a novel luso-inotropic agent for the treatment of acute heart failure. Curr Opin Investig Drugs. 2007 Sep;8(9):769-77.
PubMed 17729189Adamson PB, Vanoli E, Mattera GG, Germany R, Gagnol JP, Carminati P, Schwartz PJ. Hemodynamic effects of a new inotropic compound, PST-2744, in dogs with chronic ischemic heart failure. J Cardiovasc Pharmacol. 2003 Aug;42(2):169-73. doi: 10.1097/00005344-200308000-00003.
PubMed 12883318Ferrari P, Micheletti R, Valentini G, Bianchi G. Targeting SERCA2a as an innovative approach to the therapy of congestive heart failure. Med Hypotheses. 2007;68(5):1120-5. doi: 10.1016/j.mehy.2006.08.045. Epub 2006 Nov 17.
PubMed 17113239Shah SJ, Blair JE, Filippatos GS, Macarie C, Ruzyllo W, Korewicki J, Bubenek-Turconi SI, Ceracchi M, Bianchetti M, Carminati P, Kremastinos D, Grzybowski J, Valentini G, Sabbah HN, Gheorghiade M; HORIZON-HF Investigators. Effects of istaroxime on diastolic stiffness in acute heart failure syndromes: results from the Hemodynamic, Echocardiographic, and Neurohormonal Effects of Istaroxime, a Novel Intravenous Inotropic and Lusitropic Agent: a Randomized Controlled Trial in Patients Hospitalized with Heart Failure (HORIZON-HF) trial. Am Heart J. 2009 Jun;157(6):1035-41. doi: 10.1016/j.ahj.2009.03.007. Epub 2009 Apr 23.
PubMed 19464414Gheorghiade M, Blair JE, Filippatos GS, Macarie C, Ruzyllo W, Korewicki J, Bubenek-Turconi SI, Ceracchi M, Bianchetti M, Carminati P, Kremastinos D, Valentini G, Sabbah HN; HORIZON-HF Investigators. Hemodynamic, echocardiographic, and neurohormonal effects of istaroxime, a novel intravenous inotropic and lusitropic agent: a randomized controlled trial in patients hospitalized with heart failure. J Am Coll Cardiol. 2008 Jun 10;51(23):2276-85. doi: 10.1016/j.jacc.2008.03.015. Epub 2008 Apr 9.
PubMed 18534276
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Assess the Hemodynamic Effects of Istaroxime, a Novel Lusinotropic Agent, in Patients Hospitalized With Worsening Heart Failure and a Reduced Left Ventricular Systolic Function
- ClinicalTrials.gov ID
- NCT00616161
- Acronym / sponsor ID
- HORIZON-HF / PST2744-DM-04-012
- Conditions
- Heart Failure
- Keywords
- Acute Heart Failure, Inotropes, Lusitropic agents, Istaroxime, PST2744
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- sigma-tau i.f.r. S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- MDS Pharma Services
- Study start
- Aug 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 15 Feb 2008 (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 determine the minimum effective dose of Istaroxime, in patients requiring hospitalization for deterioration of chronic heart failure and left ventricular systolic dysfunction. This goal will be reached by comparing the hemodynamic effect of three different doses of the drug versus placebo. Efficacy will be measured as a change in Pulmonary Capillary Wedge Pressure from pre-infusion to the last assessment at six hours intravenous infusion.Secondary objectives will be to evaluate safety, tolerability and efficacy on other main hemodynamic parameters, echocardiographic and echo-doppler measurements, plus preliminary pharmacokinetics of the drug.
Detailed description
Congestive heart failure is one of the most common cardiovascular conditions and it is presently reaching epidemic proportions. The prevalence of chronic heart failure has risen specifically as a result of the increased longevity and longer survival after myocardial infarction. In 2003, over one million hospitalization with a primary diagnosis of heart failure occurred in the United States of America, and a similar number has been reported in Europe, too. At present, approximately 5 million Americans are estimated to suffer of this syndrome and the number is expected to continue to increase with the increase and aging of the population. Despite advances in treatment, the mortality remains high in U.S.A. as in Europe, with nearly three hundred thousands patients dying of CHF as the primary or contributory cause each year.
The total number of hospital admissions approaches 3 million yearly when HF is listed as a primary or secondary diagnosis. Although these patients have a relatively low mortality during the hospitalization (less than 4%), the readmission rates within 60 days of discharge range from 20 to 30% and mortality within 60 days of discharge is 5 - 10%.
The primary aim of acute treatment of worsening CHF is to alleviate the symptoms of congestion and edema, improve the hemodynamic profile, and preserve renal function without causing myocardial injury. Improved hemodynamics usually results in relief of primary symptoms like dyspnea and edema and in a consequent improved sense of wellbeing and mental status. The improvement in hemodynamics may persist after the pharmacological interventions used in the acute phase are withdrawn.
The need in this setting is to decrease the filling pressures (RA pressure and PCWP), increase cardiac output, without increasing the heart rate and inducing/worsening atrial or ventricular arrhythmias. In addition, the agent should improve diastolic function, modulate the exaggerated neurohormonal responses to CHF and preserve/protect the viable but non contractile myocardium (e.g.: the hibernated myocardium). The agent should also facilitate the earlier start of life-saving therapies (e.g. beta - blockers).Pre-clinical data on Istaroxime show that this drug increases contractility without increasing heart rate and oxygen consumption; furthermore it is improving diastolic dysfunction and it not causing vasodilatation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IstaroximeIstaroxime dose of 0.5 microgram/kg body weight/minute of iv infusion for six ours |
| 2 | Experimental | Drug: IstaroximeIstaroxime dose of 1.0 microgram/kg body weight/minute of iv infusion for six ours |
| 3 | Experimental | Drug: IstaroximeIstaroxime dose of 1.5 microgram/kg body weight/minute of iv infusion for six ours |
| 4 | Placebo comparator | Drug: PlaceboPlacebo iv infusion for six ours |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signing of a written informed consent form.
- Male or female patients aged between 18 and 85 years.
- Negative pregnancy test at screening, for women of childbearing potential.
- Body weight less or equal to 100 kg.
- Blood pressure not more than SAP=150 or DAP=90 mmHg.
Key exclusion criteria (23 listed)
- Ongoing treatment with oral or intravenous inotropes and/or inodilators.
- Patient treated with digoxin within the last week, can be randomised if the plasma concentration of digoxin are tested before randomisation and its value will be less than 0.5 ng/ml.
- Intermittent inotropes administration within 2 weeks.
- Symptoms of Heart Failure at randomization e.g.: dyspnoea
- Systolic blood pressure < 90 mmHg.
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 |
|---|---|---|
| IstaroximeAlso: PST27440.5 microgram/kg/min IV for 6 hours | Drug | 1 |
| IstaroximeAlso: PST27441.0 microgram/kg/min IV for 6 hours | Drug | 2 |
| IstaroximeAlso: PST27441.5 microgram/kg/min IV for 6 hours | Drug | 3 |
| PlaceboAlso: placebo of PST2744Placebo | Drug | 4 |
Primary outcome
To determine the minimum effective dose of ISTAROXIME by comparing the hemodynamic effect of 3 different doses of the drug versus placebo. Efficacy will be measured as a change in PCWP from right heart catheterization.
Time frame: 6 hours drug infusion
1 secondary outcome
safety, tolerability and efficacy on blood pressure, heart rate, cardiac index, stroke work index, right atrial pressure, systemic and pulmonary vascular resistances, Echocardiographic and Doppler parameters, neurohormonal parameters and renal function.
Time frame: 6 and 24 hours after start of infusion
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 15 Feb 2008.
- Background: PubMed 17239700Gheorghiade M, Sabbah HN. Istaroxime: an investigational luso-inotropic agent for acute heart failure syndromes. Am J Cardiol. 2007 Jan 22;99(2A):1A-3A. doi: 10.1016/j.amjcard.2006.09.001. Epub 2006 Sep 18. No abstract available.
- Background: PubMed 17239701Micheletti R, Palazzo F, Barassi P, Giacalone G, Ferrandi M, Schiavone A, Moro B, Parodi O, Ferrari P, Bianchi G. Istaroxime, a stimulator of sarcoplasmic reticulum calcium adenosine triphosphatase isoform 2a activity, as a novel therapeutic approach to heart failure. Am J Cardiol. 2007 Jan 22;99(2A):24A-32A. doi: 10.1016/j.amjcard.2006.09.003. Epub 2006 Sep 25.
- Background: PubMed 17239702Mattera GG, Lo Giudice P, Loi FM, Vanoli E, Gagnol JP, Borsini F, Carminati P. Istaroxime: a new luso-inotropic agent for heart failure. Am J Cardiol. 2007 Jan 22;99(2A):33A-40A. doi: 10.1016/j.amjcard.2006.09.004. Epub 2006 Sep 18.
- Background: PubMed 17239704Sabbah HN, Imai M, Cowart D, Amato A, Carminati P, Gheorghiade M. Hemodynamic properties of a new-generation positive luso-inotropic agent for the acute treatment of advanced heart failure. Am J Cardiol. 2007 Jan 22;99(2A):41A-46A. doi: 10.1016/j.amjcard.2006.09.005. Epub 2006 Sep 18.
- Background: PubMed 17239705Ghali JK, Smith WB, Torre-Amione G, Haynos W, Rayburn BK, Amato A, Zhang D, Cowart D, Valentini G, Carminati P, Gheorghiade M. A phase 1-2 dose-escalating study evaluating the safety and tolerability of istaroxime and specific effects on electrocardiographic and hemodynamic parameters in patients with chronic heart failure with reduced systolic function. Am J Cardiol. 2007 Jan 22;99(2A):47A-56A. doi: 10.1016/j.amjcard.2006.09.006. Epub 2006 Sep 20.
- Background: PubMed 17729189Wehrens XH. Istaroxime, a novel luso-inotropic agent for the treatment of acute heart failure. Curr Opin Investig Drugs. 2007 Sep;8(9):769-77.
- Background: PubMed 12883318Adamson PB, Vanoli E, Mattera GG, Germany R, Gagnol JP, Carminati P, Schwartz PJ. Hemodynamic effects of a new inotropic compound, PST-2744, in dogs with chronic ischemic heart failure. J Cardiovasc Pharmacol. 2003 Aug;42(2):169-73. doi: 10.1097/00005344-200308000-00003.
- Background: PubMed 17113239Ferrari P, Micheletti R, Valentini G, Bianchi G. Targeting SERCA2a as an innovative approach to the therapy of congestive heart failure. Med Hypotheses. 2007;68(5):1120-5. doi: 10.1016/j.mehy.2006.08.045. Epub 2006 Nov 17.
- Derived from this study: PubMed 19464414Shah SJ, Blair JE, Filippatos GS, Macarie C, Ruzyllo W, Korewicki J, Bubenek-Turconi SI, Ceracchi M, Bianchetti M, Carminati P, Kremastinos D, Grzybowski J, Valentini G, Sabbah HN, Gheorghiade M; HORIZON-HF Investigators. Effects of istaroxime on diastolic stiffness in acute heart failure syndromes: results from the Hemodynamic, Echocardiographic, and Neurohormonal Effects of Istaroxime, a Novel Intravenous Inotropic and Lusitropic Agent: a Randomized Controlled Trial in Patients Hospitalized with Heart Failure (HORIZON-HF) trial. Am Heart J. 2009 Jun;157(6):1035-41. doi: 10.1016/j.ahj.2009.03.007. Epub 2009 Apr 23.
- Derived from this study: PubMed 18534276Gheorghiade M, Blair JE, Filippatos GS, Macarie C, Ruzyllo W, Korewicki J, Bubenek-Turconi SI, Ceracchi M, Bianchetti M, Carminati P, Kremastinos D, Valentini G, Sabbah HN; HORIZON-HF Investigators. Hemodynamic, echocardiographic, and neurohormonal effects of istaroxime, a novel intravenous inotropic and lusitropic agent: a randomized controlled trial in patients hospitalized with heart failure. J Am Coll Cardiol. 2008 Jun 10;51(23):2276-85. doi: 10.1016/j.jacc.2008.03.015. Epub 2008 Apr 9.
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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.
Mihai Gheorghiade, MD FACC study chair
Northwestern University Feinberg School of Medicine - Chicago
Witold Ruzyllo, MD principal investigator
National Institute of Cardiology, Department of Coronary Artery Disease - Warsaw - POLAND
Cezar Macarie, MD principal investigator
Insitutul de Boli Cardiovasculare C.C. Iliescu Bucuresti, Bucharest - ROMANIA
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Istaroxime in people with Heart Failure, run by sigma-tau i.f.r. S.p.A..
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 13 inclusion and 23 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 15 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To determine the minimum effective dose of ISTAROXIME by comparing the hemodynamic effect of 3 different doses of the drug versus placebo. Efficacy will be measured as a change in PCWP from right heart catheterization. (time frame: 6 hours drug infusion). 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 NCT00616161, which also lists 10 linked publications.
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 15 Feb 2008.