EUCTR2016-003968-39-GB
Active, not recruiting
Phase 1
Renal and Cardiovascular Effects of SGLT2 inhibition in combination with loop diuretics in diabetic patients with chronic heart failure. - The RECEDE-CHF Trial
niversity of Dundee/NHS Tayside0 sites23 target enrollmentMay 15, 2018
ConditionsType 2 diabetes and heart failureMedDRA version: 20.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849MedDRA version: 20.0Level: LLTClassification code 10010684Term: Congestive heart failureSystem Organ Class: 100000004849MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsJardiance
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 diabetes and heart failure
- Sponsor
- niversity of Dundee/NHS Tayside
- Enrollment
- 23
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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