SGLT2 Inhibition in Diabetes and Heart Failure

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

SGLT2 Inhibition in Diabetic Patients With Heart Failure With Reduced Ejection Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862067
• Other study ID #: HM20007722
• Secondary ID: 16MCPRP31100003
• Status: Completed
• Start date: July 2016
• Est. completion date: January 16, 2018

Study information

• Verified date: July 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure.

Description:

The investigators hypothesize that Sodium-GLucose coTransporters (SGLT)-2 inhibition will improve cardio-respiratory fitness (CRF) in patients with systolic heart failure.

Participants treated with SGLT2 inhibitor Empagliflozin as standard of care will undergo assessments described below.

The investigators will measure CRF with a validated cardiopulmonary exercise test at baseline and after 4 weeks of treatment received as standard of care, to determine whether SGLT2 inhibition improves cardio-respiratory fitness assessed by changes in peak oxygen consumption (VO2)(mL/kg/min) and minute ventilation (VE)/carbon dioxide production (VCO2) slope, powerful independent clinical predictors of mortality in HF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 16, 2018
• Est. primary completion date: January 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed clinical diagnosis of stable HF (NYHA class II-III) on maximally tolerated HF medical regimen including angiotensin-inhibitors, beta-adrenergic blockers, and loop diuretics

• Reduced left ventricular systolic function (LVEF<50%) documented in the prior 12 months

• Poorly controlled T2DM (HbA1c levels between 6.5% and 10.0%)

• 18 years old and older.

Exclusion Criteria:

• Type I diabetes;

• Type II diabetes with episodes of severe hypoglycemia <50 mg/dl by history, frequent changes in anti-diabetic regimen class in the past 3 months or with a prior episode of diabetic ketoacidosis (any time);

• Open label treatment with SGLT2 inhibitors (within the past month);

• Treatment with thiazolidinedione (within the past month), which may induce volume and sodium retention;

• Chronic Kidney Disease (GFR<45 ml/kg*min);

• Uncontrolled thyroid dysfunction (TSH<0.4>4.5 mcIU/ml);

• Pregnancy or of child-bearing potential;

• Active or recent (within 2 weeks) genital/urinal infection;

• Concomitant conditions or treatment which would affect completion or interpretation of the study including physical inability to walk or run on a treadmill such as decompensated HF (edema, NYHA class IV), significant ischemic heart disease, angina, arterial hypotension (BP systolic <90 mmHg), orthostatic arterial hypotension, arterial hypertension (resting BP systolic >160 mmHg), atrial fibrillation with rapid ventricular response, severe valvular disease, severe chronic obstructive or restrictive pulmonary disease, moderate- severe anemia (Hgb<10 g/dl);

• Abnormal BP or heart rate response, angina or ECG changes (ischemia or arrhy- thmias) occurring during baseline cardio-pulmonary exercise testing;

• Chronic use of oral corticosteroids;

• Inability to give informed consent.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure
• Heart Failure, Systolic

Intervention

Other:
• Assessment of cardiorespiratory fitness
Assessment of cardiorespiratory fitness

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

Carbone S, Canada JM, Billingsley HE, Kadariya D, Dixon DL, Trankle CR, Buckley LF, Markley R, Vo C, Medina de Chazal H, Christopher S, Buzzetti R, Van Tassell BW, Abbate A. Effects of empagliflozin on cardiorespiratory fitness and significant interaction — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SGLT2 inhibition effects on cardiorespiratory fitness (CRF).	To measure the effects of Empagliflozin on cardiorespiratory fitness in patients with type 2 diabetes and heart failure with reduced ejection fraction or systolic heart failure. The effects on CRF are determined by measuring changes in peak VO2 (mL/kg/min) and the VE/VCO2 slope.	4 weeks

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