Myocardial protection with Perhexiline in Left Ventricular Hypertrophy - Perhexiline in LVH

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002376-95-GB

Enrollment

220

Registered

2008-11-17

Start date

2009-01-05

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with left ventricular hypertrophy undergoing aortic valve surgery (with or without coronary artery surgery)

Interventions

Trade Name: Pexsig Product Name: Pexsig Pharmaceutical Form: Tablet INN or Proposed INN: Perhexiline CAS Number: 6724-53-4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients with left ventricular hypertrophy undergoing first-time aortic valve replacement surgery with or without 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Diabetes mellitus, renal impairment (serum creatinine> 200µmol/L), pregnancy, procedures involving other heart valves and surgery for catastrophic event.

Design outcomes

Primary

Measure	Time frame
Main Objective: During cardiac surgery, a cross-clamp is placed on the ascending aorta distal to the origin of the coronary arteries which results in complete cessation of blood flow through the myocardium. Perhexiline maleate is an anti-anginal drug that potently inhibits the mitochondrial FFA uptake enzymes CPT1 and CPT2, thus shifting myocaridal substrate metabolism from FFA to glucose. We hypothesise that preoperative loading with perhexiline in patients undergoing cardiac surgery on cardiopulmonary bypass will improve myocardial protection during cardiac surgery. ;Secondary Objective: The secondary hypothesis is that enhances in myocardial protection are through improving energy conservation (high energy phosphates).;Primary end point(s): Incidence of low cardiac output syndrome (LCOS) after surgery. This is an indicator of inadequate myocardial protection and for the purpose of this study, LCOS is defined as hypotension (mean arterial pressure 75 bpm) where systolic blood pressure 60 minutes to maintain such a clinical picture.	—

Measure

Time frame

Main Objective: During cardiac surgery, a cross-clamp is placed on the ascending aorta distal to the origin of the coronary arteries which results in complete cessation of blood flow through the myocardium. Perhexiline maleate is an anti-anginal drug that potently inhibits the mitochondrial FFA uptake enzymes CPT1 and CPT2, thus shifting myocaridal substrate metabolism from FFA to glucose. We hypothesise that preoperative loading with perhexiline in patients undergoing cardiac surgery on cardiopulmonary bypass will improve myocardial protection during cardiac surgery. ;Secondary Objective: The secondary hypothesis is that enhances in myocardial protection are through improving energy conservation (high energy phosphates).;Primary end point(s): Incidence of low cardiac output syndrome (LCOS) after surgery. This is an indicator of inadequate myocardial protection and for the purpose of this study, LCOS is defined as hypotension (mean arterial pressure 75 bpm) where systolic blood pressure 60 minutes to maintain such a clinical picture.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026