E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Angina CCS class IV treated with coronary artery bypass surgery
Coronary artery disease with moderate to severe left ventricular dysfunction treated with coronary artery bypass surgery
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Angina CCS klass IV som behandlas med kranskärlsoperation
Kranskärlssjukdom med måttligt till uttalat nedsatt vänsterkammarfunktion som behandlas med kranskärlsoperation
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E.1.1.1 | Medical condition in easily understood language |
Severe angina treated with coronary artery bypass surgery
Coronary artery disease with depressed heart function treated with coronary artery bypass surgery
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Svår lättutlöst kärlkramp som behandlas med kranskärlsoperation
Kranskärlssjukdom med nedsatt hjärtfunktion som behandlas med kranskärlsoperation
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068176 |
E.1.2 | Term | Coronary artery bypass graft |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate if intravenous glutamate infusion given in association with coronary artery bypass surgery can prevent or mitigate postoperative heart failure that leads to prolonged stay in intensive care, renal failure or death. |
Att undersöka om intravenös glutamatinfusion i samband med kranskärlsoperation minska risken för hjärtsvikt som leder till förlängd intensivvård, njursvikt eller död. |
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E.2.2 | Secondary objectives of the trial |
To address the safety of the intravenous glutamate infusion. |
Säkerhetsaspekter relaterade till intravenös glutamatinfusion. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Angina CCS class IV treated with coronary artery bypass surgery
Coronary artery disease with moderate to severe left ventricular dysfunction treated with coronary artery bypass surgery
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Angina CCS klass IV som behandlas med kranskärlsoperation
Kranskärlssjukdom med måttligt till uttalat nedsatt vänsterkammarfunktion som behandlas med kranskärlsoperation
|
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E.4 | Principal exclusion criteria |
Informed consent not possible because of critical condition, informed consent not possible because of or other reason, preoperative use of inotropic drugs or mechanical circulatory assist, preoperative dialysis or p-creatinine > 250 µmol/l, redo-procedure, patients having concomitant valve procedure or ablation for atrial fibrillation, unexpected intraoperative finding or event that increases the dignity of the procedure to overshadow the originally planned operation, age > 85 years, and food allergy known to have caused flush, rash or asthma. |
Patienter som är i så dåligt skick att de inte kan tillfrågas om deltagande, patienter som av språkliga eller andra skäl inte kan lämna informerat samtycke, patienter som kräver inotropa droger eller mekaniskt cirkulationsstöd (aortaballongpump) pga cirkulationssvikt redan innan de inkluderats i studien, patienter med preoperativ dialys eller p-kreatinin >250 µmol/l, patienter som tidigare hjärtopererats, patienter som genomgår samtidig klaffoperation eller flimmerablation, oförutsedd betydande utvidgning av det operativa ingreppet som kraftigt överskuggar den planerade operationens dignitet (exempelvis aorta ascendenskirurgi, svårartade blödningskomplikationer intraoperativt), patienter > 85 år, patienter med oklar födoämnesallergi som utlöst andnöd, urticaria eller flush; patienter med diabetes, |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is a composite of a) cardiac mortality (30-days or in-hospital) b) severe postoperative heart failure according to prespecified criteria c) renal failure (increase of p-creatinine x2 or new onset dialysis postoperatively)
The criteria for severe postoperative heart failure are postoperative heart failure requiring ≥ 3 days stay in intensive care with inotropic drugs running 48 hours postoperatively and at least for 24 hours in prespecified dosages. |
Den primära endpointen är en komposit av a) kardiell mortalitet (30-dagar + sjukhusmortalitet) b) betydande postoperativ hjärtsvikt enligt prespecificerade kriterier c) njursvikt (nytillkommet dialysbehov eller dubblering av p-kreatinin)
.
Kriterierna för betydande postoperativ hjärtsvikt är postoperativ hjärtsvikt med NT-proBNP > 5000 ng/l på tredje postoperativa dagen som krävt ≥ 3 dygns intensivvård med kvarstående inotrop behandling 48 timmar efter operation och minst 24 timmars total behandlingstid i prespecificerade doser
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days or first hospitalization (including referral hospital and the hospital where surgery is performed) |
30 dagar eller första sjukhusvistelsen (inkluderande remittentsjukhus och behandlande sjukhus) |
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E.5.2 | Secondary end point(s) |
Safety of the intervention. |
Säkerhetsaspekter relaterade till interventionen. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Hospitalization at the hospital where surgery is performed. |
Sjukhusvistelsen på behandlande sjukhus. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is 30 days after the last patient was included or the date for the last hospital day if the duration of hospitalization of an included patients extends beyond that date. |
Studiens slutpunkt är 30 dagar efter den sista inkluderade patienten eller den sista sjukhusdagen om sjukhusvistelsen för någon inkluderad patient sträcker sig längre fram i tiden. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |