Clinical trial
GLP-1/GIP Receptor Agonists in Obesity-Related HFpEF: The GLIDE-HF Registry
Opening soon · Not applicable · 1 countries · Registry ID NCT07787936
What this study is about
GLIDE-HF is a prospective, single-center, non-interventional observational cohort registry conducted within routine outpatient heart failure care at a cardiology clinic in Poland. It enrolls patients with obesity-related heart failure with preserved ejection fraction (HFpEF), defined by chronic heart failure symptoms or exertional dyspnea, body mass index at least 30 kg/m2, left ventricular ejection fraction at least 50%, and objective evidence of HFpEF using contemporary diagnostic scores (H2FPEF and HFA-PEFF), without a dominant alternative cause of dyspnea. The registry's guiding principle is that all eligible obesity-related HFpEF patients are enrolled regardless of their treatment. Therapy with a glucagon-like peptide-1 (GLP-1) receptor agonist or a dual GLP-1/GIP receptor agonist (for example semaglutide, tirzepatide, liraglutide, dulaglutide, or others) is an observed exposure, not an assigned intervention. All decisions about initiating, selecting, dosing, or modifying such therapy are made solely by the treating physician according to clinical, regulatory, and reimbursement indications, as part of standard care and independently of the registry. The protocol does not propose, allocate, or modify any pharmacological treatment, does not randomize, and does not create a protocol-defined control group. Patients not receiving such therapy serve as a naturally occurring observational comparator. The scientific value of GLIDE-HF lies in deep mechanistic phenotyping rarely available in large-scale registries. The core assessment tool is serial exercise (stress) echocardiography, which allows direct evaluation of diastolic reserve during exercise, an abnormality that may be absent at rest and revealed only under load. This is complemented by lung ultrasound for pulmonary congestion (B-lines), left atrial and right ventricular strain analysis, a full iron and hepcidin panel, right ventricular-pulmonary artery coupling assessment, cardiac and congestion biomarkers (NT-proBNP, CA-125), quality of life (Kansas City Cardiomyopathy Questionnaire), and functional capacity (6-minute walk test). The identical assessment panel is applied to all enrolled patients regardless of treatment status, ensuring comparability between treated and untreated patients. Observation is embedded in the routine outpatient visit schedule, with assessment points at baseline and at 12, 24, and 52 weeks, and the possibility of continued follow-up. The registry characterizes trajectories of exercise diastolic reserve and accompanying mechanistic and clinical parameters over time in treated patients (primary axis), and explores comparisons between treated and untreated patients (secondary axis), with a methodological aim of assessing the feasibility of reliable serial exercise echocardiography and lung ultrasound in an unselected, real-world obesity-related HFpEF population, in whom obesity substantially complicates imaging. The registry is descriptive and hypothesis-generating. Because of its observational design, all analyses relating to treatment effect are descriptive only and cannot be interpreted as evidence of a causal drug effect, given the absence of randomization, possible regression to the mean, and confounding by indication. Target enrollment is at least 150 patients, recruited continuously from January 2027. GLIDE-HF is a non-commercial study conducted under bioethics committee opinion and applicable data protection law.
Basic eligibility
Full registry criteria
Treatments and study arms
GLP-1 / GIP receptor agonist
Observed exposure, not assigned by the registry. GLP-1 or dual GLP-1/GIP receptor agonist (semaglutide, tirzepatide, liraglutide, dulaglutide, or others) prescribed by the treating physician as routine clinical care per the Summary of Product Characteristics and reimbursement rules. The registry documents molecule, dose, escalation, start date, modifications, discontinuations, tolerability, and adverse events, but does not propose, allocate, or modify treatment.
Primary outcomes
Change over time in the highest interpretable exercise (stress) echocardiographic average E/e' ratio, a non-invasive estimate of left ventricular filling pressure during exercise, in the GLP-1/GIP receptor agonist-exposed cohort. The highest interpretable value is selected per the protocol hierarchy (peak \> 40 W \> 20 W). Reported as mean change from baseline with 95% confidence intervals from a linear mixed model accounting for actual time since baseline; descriptive and hypothesis-generating, not a confirmatory test of treatment effect. Unit: ratio (dimensionless).
Study locations
1 locations were listed when this page was built. The first 40 are shown.