Impact of Glucagon on Physical Capacity and Metabolism

Trial details

Who runs it

Katholisches Klinikum Bochum gGmbH

Trial code

EU 2025-521835-35-00

Record updated

2026. szeptember 25.

Original description

To investigate the metabolic effects and impact on physical performance as measured by VO2max of continuously subcutaneously administered glucagon in HFpEF patients with and without concomitant MASLD.Read full original descriptionShow less

To investigate the metabolic effects and impact on physical performance as measured by VO2max of continuously subcutaneously administered glucagon in HFpEF patients with and without concomitant MASLD.

Inclusion: Age between 18 - 80 years and able to understand the requirements of the study and willing to provide signed informed consent for voluntary participation in the study; Patients with clinically confirmed heart failure with preserved ejection fraction (HFpEF) by: a) Symptoms and signs of heart failure b) Left ventricular ejection fraction ≥ 45% c) Objective signs of structural and/or functional cardiac dysfunction consistent with the presence of left ventricular diastolic dysfunction/elevated left ventricular filling pressures, including elevated serum natriuretic peptides; Metabolic associated steatotic liver disease (MASLD) without higher-level fibrosis (F3) confirmed by o Transient elastography  Elasticity (E) ≥ 8 - And  At least stetosis I-II (CAP ≥248 - ≤ 280 dB/m) o Presence of at least 1 cardiometabolic criterion  BMI > 25 kg/m2  Fasting BG > 100 mg/dl or 2h postprandial >140mg/dl or already diagnosed type 2 diabetes mellitus  RR >130/85mmHg or under antihypertensive therapy  Fasting triglycerides > 150 mg/dl or under therapy  HDL < 40 mg/dl (m) and < 50 mg/dl (w).

Exclusion: Substance abuse (illegal drugs); History of acute coronary syndrome or percutaneous coronary intervention/bypass surgery or cerebrovascular event (e.g. stroke) within the last 6 months; Known allergies or intolerances in connection with study medication; Severe or high-grade heart valve stenosis and/or insufficiency; Known significant MASLD with advanced fibrosis (grade III - IV) and/or liver cirrhosis and/or alcohol-induced liver disease; Known active malignant disease and/or known active underlying inflammatory or infectious disease; Type I diabetes mellitus or insulin-dependent type II diabetes mellitus; Left ventricular ejection fraction < 45%; Known severely impaired renal function (eGFR <30ml/min according to CKD-EPI formula); Physical/physical limitations that impair mobility or performance o E.g. underlying neuromuscular diseases, anaemia (anaemia < 12 g/dl), acute and/or chronic orthopaedic diseases that restrict physical mobility/performance, congenital heart defects; Existing contraindications for carrying out a cardiopulmonary performance test; Pregnancy; Inability to give informed consent/ inability to make independent decisions; Employment relationship with the sponsor or the conducting clinic; Simultaneous participation in another clinical trial or intervention study or participation in a clinical trial or intervention study within the last 3 months; Obesity per magna (BMI >40 kg/m2).

EU CTIS 2025-521835-35-00