SGLT2i and Incretin and CRTd.

NCT03282136 | Completed Phase 4

• 1 other identifier: University of Campania
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Incretin therapy and sodium-glucose- transporter2 inhibitors (SGLT2i) are a treatment for type 2 diabetes (T2DM) affected by heart failure (HF) and treated with cardiac resynchromization therapy (CRT). In this study the investigators will recruit T2DM patients affected by HF with depressed ejection fraction and treated by CRT. These patients will randomly be treated by incretin v/s SGLT2i vs combined therapy with incretin+SGLT2i (and added to conventional hypoglicemic drugs). In these patients investigators will report at follow up CRT-d responders rate, mortality, and hospital admission for HF worsening. Combined therapy with incretin and SGLT2i may reduce hospital admissions for HF in T2DM v/s incretin and/or SGLT2i therapy (added to conventional hypoglicemic drugs).

Conditions

Type 2 Diabetes Mellitus; Heart Failure

Outcome Measures

Primary Outcomes (2)

• all cause mortality, and cardiac cause mortality.

  12 months

• CRT responders

  12 months

Secondary Outcomes (1)

• hospital admissions for HF

  12 months

Study Arms (3)

incretin arm

ACTIVE COMPARATOR

T2DM with HF treated by CRTd participants will be assigned prospectively to an intervention (incretin therapy plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.

Drug: Incretin Effect; Device: Cardiac Resynchronization therapy defibrillator device

conventional hypoglycemic drug arm

PLACEBO COMPARATOR

T2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.

Device: Cardiac Resynchronization therapy defibrillator device

Incretin added to SGLT2i

ACTIVE COMPARATOR

T2DM with HF treated by CRTd participants will be assigned prospectively to SGLT2i added to incretin therapy (plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.

Drug: SGLT-2 inhibitor

Interventions

Incretin Effect DRUG

The patients will receive incretins therapy.

incretin arm

Cardiac Resynchronization therapy defibrillator device DEVICE

The patients will receive a Cardiac Resynchronization therapy defibrillator device

conventional hypoglycemic drug arm; incretin arm

SGLT-2 inhibitor DRUG

The patients will receive SGLT2i therapy.

Incretin added to SGLT2i

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged more than 18 years, with clinical hystory of T2DM non insulin dependent, and diagnosed failing heart with depressed ejection fraction; CRTd recipients.

You may not qualify if:

• T2DM in insuline therapy; renal impairment, chronic inflammatory and systemic diseases; neoplastic diseases.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Raffaele Marfella

Naples, Italy, 80128, Italy

Location

Related Publications (1)

• Sardu C, Paolisso P, Sacra C, Santamaria M, de Lucia C, Ruocco A, Mauro C, Paolisso G, Rizzo MR, Barbieri M, Marfella R. Cardiac resynchronization therapy with a defibrillator (CRTd) in failing heart patients with type 2 diabetes mellitus and treated by glucagon-like peptide 1 receptor agonists (GLP-1 RA) therapy vs. conventional hypoglycemic drugs: arrhythmic burden, hospitalizations for heart failure, and CRTd responders rate. Cardiovasc Diabetol. 2018 Oct 22;17(1):137. doi: 10.1186/s12933-018-0778-9.

  PMID: 30348145 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Heart Failure

Interventions

Incretins; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 13, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 25, 2025

Record last verified: 2017-09

Locations

IT (1)