Perhexiline effects on inflammatory activation and insulin sensitivity in diabetics or pre-diabetics with heart disease

Phase 4

Recruiting

• Conditions: Diabetes; Cardiovascular; Metabolic and Endocrine - Diabetes; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12615000497505
• Lead Sponsor: Cardiology Department, The Queen Elizabeth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Diabetes or pre-diabetes
2. Chronic cardiac disease to be treated with perhexiline, any of the following:
(a) myocardial ischaaemia
(b) refractory angina
(c) systolic heart failure
(d) severe symptomatic aortic stenosis
(e) hypertrophic cardiomyopathy

Exclusion Criteria

1. Less than 18 years old
2. Pregnancy, or women of childbearing age who are not using effective contraception
3. Concurrent treatment with any P2Y12 antagonist or perhexiline.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in platelet content of the pro-inflammatory protein thioredoxin-interacting protein (TXNIP). This would be assessed via immunohistochemical assay (Sverdlov et al, Int J of Cardiol. 2013; 168: 4624-4630). [two weeks after perhexiline therapy]