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BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure

Study acronym: BIO-2-HEART
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated May 9, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Enrollment target: 200 to 400v3 Show 4 more changesShow less
    • Primary completion date: Mar 31, 2023 to Dec 31, 2025
    • Study completion date: Mar 31, 2024 to Dec 31, 2026
    • Study description expanded, about 42 words
    • Eligibility criteria expanded, about 3 words
  2. Phase: Not applicable to Not specifiedv2 Show 6 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2017 to Apr 1, 2018
    • Study sites: 0 to 1
    • Primary completion date: Dec 1, 2022 to Mar 31, 2023
    • Study completion date: Jun 1, 2023 to Mar 31, 2024
    • Study arms: 0 to 3
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
RWTH Aachen University
23 trials monitored
See all monitored trials
Heart Disease
8,786 trials monitored
See 412 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Type 2 Diabetes
2,231 trials monitored
See 111 trials at risk
and 1 more disease
The primary aim of the current study is a better understanding of the role of Type 2 Diabetes Mellitus (T2DM) in heart failure and, in particular, changes in cardiac metabolism, which may contribute to heart failure. Various biomarkers in the coronary artery blood, as well as in the arterial and peripheral venous blood, are to be identified for this purpose. Included are patients with and without T2DM and with or without heart failure (HFpEF, HFmrEF, HFrEF), who have a clinically indicated and guidance-appropriate Cardiac Resynchronisation Therapy (CRT) implantation or pulmonary vein ablation/electrophysiological examination. Not all patients currently benefit from the implantation of a CRT system (so-called non-responder). Despite narrow inclusion criteria, these "non-responders" cannot be unmasked in advance of the implantation. A further aim of this study is to identify biomarkers, which can be determined in advance of implantation to differentiate between responders and non-responders.
Trial Details
NCT Number NCT03323216
Lead Sponsor RWTH Aachen University
Conditions
(from sponsor)		 Heart Failure, Diabetes Mellitus, Type 2
Related terms Diabetes Mellitus, Type 2, Heart Failure
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov