Clinical trial

GLP-1/GIP Receptor Agonists in Obesity-Related HFpEF: The GLIDE-HF Registry

Opening soon · Not applicable · 1 countries · Registry ID NCT07787936

Opening soonNot applicableObservational

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionHeart Failure With Preserved Ejection Fraction, Obesity, Diastolic Heart Failure, Pulmonary Hypertension, Iron Deficiency

Full registry criteria

Inclusion Criteria: Age 18 years or older Body mass index (BMI) 30 kg/m2 or greater Symptomatic exertional dyspnea, fatigue, or reduced exercise tolerance Left ventricular ejection fraction 50% or greater Probable or established HFpEF per the diagnostic score algorithm (no low-probability result on either the H2FPEF or HFA-PEFF score) Able to perform semi-supine bicycle exercise echocardiography Written informed consent for registry participation and data processing Exclusion Criteria: Significant valvular heart disease Cardiomyopathy other than the typical HFpEF phenotype (suspected amyloidosis, restrictive or hypertrophic cardiomyopathy as the primary problem) Recent acute decompensated heart failure or recent hospitalization for heart failure Unstable coronary artery disease Severe pulmonary disease as the primary cause of dyspnea Severe anemia or another systemic cause of exercise limitation Inability to safely perform an exercise test Very poor echocardiographic window precluding any analysis Active malignancy or gynecological condition that may substantially affect CA-125 (diagnosed endometriosis, pelvic inflammatory disease, suspected ovarian tumor, significant non-cardiac ascites) Absence of consent for registry participation and data processing

Treatments and study arms

GLP-1 / GIP receptor agonist

Drug

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

Trajectory of exercise E/e' over time in GLP-1/GIP-exposed patientsBaseline, 12, 24, and 52 weeks

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.

Klinika Kardiologii, Miedziowe Centrum Zdrowia SA🇵🇱 Lubin, Lower Silesian Voivodeship, Poland
Szymon Urban, MD, PhDContact