NCT03744975CompletedPhase 2
PDD in Type 2 Diabetes w/wo Diastolic Dysfunction
Effects of Neprilysin Inhibition With ARNI (LCZ 696) on the Cardiorenal and Humoral Response to Acute Saline Volume Expansion in DM With and Without PDD
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 19 Apr 2018
- Start date
- 1 May 2018
- Primary completion date
- 27 Aug 2025
- Lead sponsor
- Mayo Clinic
- Diseases
- Type 2 diabetes
- NCT number
- NCT03744975
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 72
- From 1 May 2018 to the primary completion date, 27 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior diagnosis, or signs and symptoms, of heart failure;
- Currently taking a loop diuretic
- received an investigational drug within 1 month prior to dosing;
Other illness
- 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
- 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
- patients with an allergy to iodine
Lab values
- HbA1C\> 9 % at enrollment
- 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
Other
- sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.