PDD in Type 2 Diabetes w/wo Diastolic Dysfunction

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will advance the investigator's knowledge of the integrated cardiorenal and humoral physiology in type 2 diabetic patients with and without pre-clinical diastolic dysfunction, and test a novel therapeutic strategy which may prevent a progression to symptomatic Stage C heart failure

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Treatments: LCZ 696; Natriuretic Peptide, Brain; Sacubitril and valsartan sodium hydrate drug combination

Criteria

Inclusion Criteria

• 60 male and female subjects >18years of age

• Type 2 diabetes mellitus

• On at least one oral hypoglycemic agent, or glucagon-like peptide analogue or insulin, for at least 6 months

• EF > 50% without diastolic dysfunction or EF > 50% with grade 2 or more diastolic dysfunction, without prior diagnosis, or signs and symptoms, of heart failure

• Minimal distance of >450 meters on a 6-minute walk. If the subject is not able to walk 450 meters due to pain in hips and/or knees, and not fatigue or shortness of breath, then they will still qualify for the protocol.

Exclusion Criteria

• Age < 18 years

• HbA1C> 9 % at enrollment

• prior diagnosis, or signs and symptoms, of heart failure;

• Currently taking a loop diuretic

• myocardial infarction within 6 months of Visit 2

• unstable angina within 6 months of Visit 2

• significant (> moderate) valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis

• severe congenital heart diseases

• sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening

• second or third degree heart block without a permanent cardiac pacemaker

• stroke within 3 months of screening, or other evidence of significantly compromised CNS perfusion

• ALT >2 times the upper limit of normal

• serum sodium of < 125 mEq/dL or > 160 mEq/dL

• serum potassium of < 3.5 mEq/dL or > 5.9 mEq/dL

• hemoglobin < 9 gm/dl

• eGFR < 30 ml/min (at screening)

• other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data

• received an investigational drug within 1 month prior to dosing;

• patients with an allergy to iodine

• female subject who is pregnant or breastfeeding

• in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reason