Management of the patient with heart failure and diabetes: may insulin be a problem?

Phase 1

• Conditions: Heart failure and diabetes; MedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.1Level: LLTClassification code 10007555Term: Cardiac failure (NOS)System Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-001057-26-IT
• Lead Sponsor: IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-05
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 142

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:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 142

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified