Intravenous glutamate infusion to prevent heart failure after coronary surgery

Phase 1

• Conditions: Angina CCS class IV treated with coronary artery bypass surgeryCoronary artery disease with moderate to severe left ventricular dysfunction treated with coronary artery bypass surgery; MedDRA version: 14.1Level: LLTClassification code 10068176Term: Coronary artery bypass graftSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-006241-15-SE
• Lead Sponsor: inköping University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-27
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1400

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 900

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified