PDD in Type 2 Diabetes w/wo Diastolic Dysfunction (NCT03744975) | Clinical Trial Compass
CompletedPhase 2
PDD in Type 2 Diabetes w/wo Diastolic Dysfunction
United States72 participantsStarted 2018-05-01
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* 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
* 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…