The MET REMODEL Study

Phase 1

• Conditions: Cardiovascular disease; MedDRA version: 17.0 Level: PT Classification code 10022489 Term: Insulin resistance System Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 17.0 Level: LLT Classification code 10051615 Term: Atherosclerotic cardiovascular disease System Organ Class: 100000004866; MedDRA version: 17.0 Level: LLT Classification code 10025164 Term: LVH System Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-003189-26-GB
• Lead Sponsor: niversity of Dundee/NHS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-15
• Study Completion: 2017-08-30
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

1) Participant is willing and able to give informed consent for participation in the study
2) Aged 18 years or over
3) Documented Ischaemic Heart Disease: either angio-graphically documented coronary artery disease or a previous history of myocardial infarction/angina.
4) Have screening echocardiography based diagnosis of LVH based on ASE criteria (males >115g/m2, females >95g/m2)
5) Fasting insulin resistance index = 2.7 at screening
6) Clinic Blood pressure < 140/85 mm Hg or 24hr BP <135/85 daytime average in screening
7)Able (in the Investigators opinion) and willing to comply with all study requirements.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39

Exclusion Criteria

1) Severe cognitive impairment precluding written informed consent
2) Type 1 or 2 Diabetes mellitus
3) Chronic Heart Failure as evidenced by an echocardiogram or a diagnosis of CHF
4) Left Ventricular Ejection Fraction <45% on echocardiography screening
5) Contraindications to cardiac MRI (pacemakers, claustrophobia, metal implants, history of penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
6) Malignancy (receiving active treatment) or other life threatening diseases
7) renal disease; CKD class 3B or worse (to exclude risk of lactic acidosis)
8) Pregnancy and lactating women
9) Any other considered by a study physician to be inappropriate for inclusion
10) Participants who have participated in any other clinical trial within the previous 30 days will be excluded.

Study & Design

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