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

Conditions

• Diastolic Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Iron Deficiency
• Obesity
• Pulmonary Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

First listed

Aug 26, 2026

Start date

Jan 1, 2027

Status verified

Aug 2026

Primary completion

Jan 1, 2031

Completion

Jan 1, 2033

Study Design

Enrollment

150 participants (estimated)

Arms

• Arm: Exposed: GLP-1/GIP receptor agonist
  Patients with obesity-related HFpEF receiving a GLP-1 or dual GLP-1/GIP receptor agonist (e.g., semaglutide, tirzepatide, liraglutide, dulaglutide, or others) prescribed by the treating physician as routine care per the Summary of Product Characteristics. Therapy is an observed exposure, not assigned by protocol. Includes patients newly initiating therapy at or after enrollment (baseline at treatment start; core trajectory cohort) and patients whose therapy began before enrollment (baseline at enrollment; analyzed separately). Molecule, indication, dose, escalation, and any discontinuation are documented but not determined by the registry.
• Arm: Unexposed: observational comparator
  Patients with obesity-related HFpEF not receiving a GLP-1/GIP receptor agonist, forming a naturally occurring observational comparator rather than a protocol-assigned control arm. Reason for non-treatment is categorized: economic or access reasons only (preferred primary comparator, most clinically similar to treated patients), clinical contraindication or intolerance, or patient preference. Exposure status may change over time; the direction and date of any change are recorded to enable time-varying exposure analyses.

Primary Outcome Measure

Trajectory of exercise E/e' over time in GLP-1/GIP-exposed patients [ Time Frame: Baseline, 12, 24, and 52 weeks ]

Central Contacts

• Szymon Urban, MD, PhD
  +48696489058
  [email protected]

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