NT-proBNP Selected PreventiOn of cardiac eveNts in a populaTion of dIabetic patients without A history of Cardiac disease a prospective randomized trial

NT-proBNP Selected PreventiOn of cardiac eveNts in a populaTion of dIabetic patients without A history of Cardiac disease a prospective randomized trial - Prevention of cardiac events by T2DM patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47526

Enrollment

200

Registered

2019-11-12

Start date

2018-03-16

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes cardiac disease diabetes mellitus

Interventions

Echocardiography, ECG, bloodsamples and EuroQOL

Prevention cardiac events T2DM

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Type-2 diabetes mellitus for at least six months >18 years of age men or female written informed consent to participate in the study and ability to comply with all requirements

Exclusion criteria

Exclusion criteria: maximum dose of RAS-antagonists or beta-blocker symptomatic hypotension and/or systolic blood pressure 2.5 mg/dl

Design outcomes

Primary

Measure	Time frame
Superiority of high dose treatment with RAS-antagonists and beta-blockers compared to conventional therapy regarding the reduction of unplanned hospitalization or death due to a cardiac event in T2DM patients with a NT-proBNP > 125pg/ml. Co-primary objective Superiority of high dose treatment with RAS-antagonists and beta-blockers compared to conventional therapy regarding the reduction of unplanned hospitalization or death due to a cardiac event in T2DM patients in the whole study population	—

Measure

Time frame

Superiority of high dose treatment with RAS-antagonists and beta-blockers compared to conventional therapy regarding the reduction of unplanned hospitalization or death due to a cardiac event in T2DM patients with a NT-proBNP > 125pg/ml. Co-primary objective Superiority of high dose treatment with RAS-antagonists and beta-blockers compared to conventional therapy regarding the reduction of unplanned hospitalization or death due to a cardiac event in T2DM patients in the whole study population

—

Secondary

Measure	Time frame
Dependency of treatment efficacy (reduction of unplanned hospitalization or death due to a cardiac event in T2DM patients) on the NT-proBNP concentration (interaction effect between NT-proBNP concentrations and treatment).	—

Countries

Austria, Netherlands, New Zealand

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)