EUCTR2018-001057-26-IT
Active, not recruiting
Phase 1
Management of the patient with heart failure and diabetes: may insulin be a problem? A pilot randomized clinical study (Insulin-HF). - Insulin-HF
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 sites142 target enrollmentNovember 5, 2020
ConditionsHeart failure and diabetesMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.1Level: LLTClassification code 10007555Term: Cardiac failure (NOS)System Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Heart failure and diabetes
- Sponsor
- IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
- Enrollment
- 142
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Men and women aged \=70 years;
- •2\.at discharge after admission to hospital for worsening of HF or ambulatory patients with chronic HF;
- •3\.New York Heart Association (NYHA) class II or III;
- •4\.with any level of left ventricular ejection fraction;
- •5\.plasma natriuretic peptide (BNP) \=200 pg/mL or N\-terminal pro\-BNP \=900 pg/mL (NT pro\-BNP)
- •6\.prior history or newly diagnosed T2DM
- •7\.candidate by the responsible physician to insulin therapy;
- •8\.signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •1\.significant renal insufficiency (GFR \<30 mL/min/1\.73 m2\) or severe liver disease (liver function test abnormalities (alanine or aspartate aminotransferase \= 3 × upper limit of normal \[ULN]);
- •2\.levels of hemoglobin \<10 g/dl;
- •3\.HbA1c \=5% or \=11%;
- •4\.unstable diabetes: type of diabetes presentation in patients with an anamnesis of frequent episodes of hypoglycemia, hyperglycemic hyperosmolar status, ketoacidosis or lacto acidosis;
- •5\.planned CV surgery or angioplasty in 3 months;
- •6\.any non\-cardiac disease that shortens life expectancy to\<1 year (e.g. most cancers);
- •7\.inability to comply with study protocol;
- •8\.participation to another interventional clinical study.
Outcomes
Primary Outcomes
Not specified
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