SGLT2 Inhibition in Diabetes and Heart Failure

NCT02862067 | Completed

• 2 other identifiers: HM2000772216MCPRP31100003
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2; Heart Failure, Systolic

Keywords

SGLT2; type 2 diabetes mellitus; systolic heart failure; heart failure with reduced ejection fraction

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Assessment of cardiorespiratory fitness OTHER

Assessment of cardiorespiratory fitness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with type 2 Diabetes Mellitus and Heart Failure with reduced Ejection Fraction or Systolic Heart Failure.

You may qualify if:

• 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%)
• years old and older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• American Heart Association: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related 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 of loop diuretics. Diabetes Obes Metab. 2018 Aug;20(8):2014-2018. doi: 10.1111/dom.13309. Epub 2018 Apr 23.

  PMID: 29603546 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Salvatore Carbone, PhD, MS

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 10, 2016
• Study Start: July 1, 2016
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: July 16, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)