Nadciśnienie płucne: badanie obserwacyjne

Gdzie prowadzone jest badanie

Ośrodki prowadzące badanie w Polsce (1), alfabetycznie według miejscowości:

• Klinika Kardiologii, Miedziowe Centrum Zdrowia SA Wkrótce rekrutacja
  LubinKontakt

Więcej badań w tych miastach:

• Lubin

Stan rekrutacji pochodzi z rejestrów badań i może się zmienić szybciej, niż zaktualizuje go sponsor. Nasz doradca sprawdzi aktualny stan w wybranym ośrodku. Nie publikujemy nazwisk lekarzy ani ich danych kontaktowych.

Cel badania

Opis z rejestru (w języku angielskim):

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.

Leczenie w badaniu

Kryteria udziału

Kryteria w języku angielskim, tak jak w rejestrze.

To główne kryteria z rejestru. Pełną listę i ostateczną decyzję o udziale ustala lekarz prowadzący badanie.

Inne badania: nadciśnienie płucne

RekrutujeFaza II

Włóknienie płuc: badanie fazy II leku TX000045

Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease

Badane leki: TX000045

Miasta: Kraków, Lublin, WrocławWiek: od 18 latSponsor: Tectonic Operating Company Inc.

RekrutujeFaza II/III

Badanie fazy II/III leku IKT-001

An Adaptive Program of IKT-001 in Pulmonary Arterial Hypertension (PAH)

Badane leki: IKT-001+25

Miasta: Katowice, Kraków, ŁódźWiek: od 18 latSponsor: Inhibikase Therapeutics Inc.

RekrutujeFaza II

Badanie fazy II leku REGN13335

Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)

Badane leki: REGN13335+4

Miasta: Białystok, Bydgoszcz, Katowice, Kraków i 2 inne miastaWiek: od 18 latSponsor: Regeneron Pharmaceuticals Inc.

RekrutujeFaza III

Badanie fazy III leku TNX-103

LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2

Badane leki: TNX-103+8

Miasta: Grodzisk Mazowiecki, Poznań, WrocławWiek: od 18 latSponsor: Tenax Therapeutics Inc.

RekrutujeFaza III

Włóknienie płuc: badanie fazy III leku L606

A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD

Badane leki: L606+14

Miasta: Kraków, Lublin, PoznańWiek: od 18 latSponsor: Liquidia Technologies Inc.

RekrutujeFaza III

Włóknienie płuc: badanie fazy III leku INS1009

A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

Badane leki: INS1009+24

Miasta: Białystok, Kraków, Lublin, WarszawaWiek: od 18 latSponsor: Insmed Inc.

Wszystkie badania: nadciśnienie płucne