The RECEDE-CHF Trial

Phase 1

• Conditions: Type 2 diabetes and heart failure; MedDRA version: 20.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code 10010684Term: Congestive heart failureSystem Organ Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849; MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003968-39-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: 2018-05-15
• Study Completion: 2019-01-09
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

•Aged 18 to 80 years with previously diagnosed Type 2 Diabetes Mellitus.
•Are diagnosed with NYHA Functional class II-III HF with prior echocardiographic evidence of LVSD.
•On stable doses of furosemide, or alternative loop diuretic for at least one month.
•Stable Type 2 Diabetes (HbA1c, in the last 3 months, of 6.5% = and =10.0%)
•eGFR = 45 ml/min.
•Have stable HF symptoms for at least three months prior to consent
•On stable HF therapy for at least three months prior to consent
•Have not been hospitalised for HF for at least three months prior to consent.
•Women of childbearing potential (WoCBP) must agree to take precautions to avoid pregnancy throughout the trial and for 4 weeks after intake of the last dose.

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 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

•A diagnosis of chronic liver disease and/or liver enzymes that are twice the upper limit of normal
•Systolic BP of <95mmHg at screening visit.
•Participants on thiazide diuretics.
•Participants receiving renal dialysis
•Participants who have previously had an episode of diabetic ketoacidosis.
•Participants with type 1 diabetes mellitus
•Malignancy (receiving active treatment) or other life threatening disease.
•Pregnant or lactating women
•Participants with difficulty in micturition e.g. severe prostate enlargement
•Allergy to any SGLT2 inhibitor or lactose or galactose intolerance
•Past or current treatment with any SGLT2 inhibitor
•Participants who have participated in any other clinical interventional trial of an investigational medicinal product within 30 days.
•Participants who are unable to give informed consent
•Any other reason considered by the physician to be inappropriate for inclusion.

Study & Design

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