The REFORM Trial

Phase 1

• Conditions: Type 2 diabetes and Heart Failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-002742-42-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: 2015-07-09
• Study Completion: 2017-08-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

• are aged 18 years or over
• were previously diagnosed with Type 2 Diabetes
• are diagnosed with NYHA functional I-II Heart Failure (HF) with prior echocardiographic evidence of LVSD
• on furosemide 40mg daily or less, or equivalent loop diuretic
• have stable HF symptoms for at least three months prior to consent
• on stable therapy for HF for at least three months prior to consent
• have not been hospitalised for HF for at least three months prior to consent

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 43

Exclusion Criteria

• severe hepatic disease
• renal disease defined as CKD class 3B or worse (i.e. eGFR<60ml/min)
• systolic BP <95mmHg at screening visit
• screening HbA1c <6.0%
• unable to walk to perform cardio pulmonary exercise testing or 6MWT
• on insulin, meglitinides eg, repaglinide, or 2nd generation sulphonylureas, eg glipizide
• malignancy (receiving active treatment) or other life threatening diseases
• pregnant or lactating women
• any contraindication to MRI (e.g. claustrophobia, metal implants, penetrative eye injury or exposure to metal fragments in eye requiring medical attention)
• patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days
• patients who are unable to give informed consent
• any other reason considered by a study physician to be inappropriate for inclusion.

Study & Design

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