NCT06675552Fut, nem toboroz
Non-interventional Study on Guideline Directed Medical Therapy for Patients With Heart Failure (HF) in Germany
PHenotype-based RApid SEquencing of Guideline-directed Medical Therapy for Heart Failure With Reduced Ejection Fraction (PHRASE-HF): A Multicentre, Prospective, Non-interventional Study to Examine Outcomes of Rapid In-hospital Implementation of GDMT and Its Translation From Discharge Into Routine Care
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 20.
Rövid összefoglaló (regiszter, angolul)
Heart failure (HF) is a global public health issue that affects more than 63 million people worldwide. The clinical and economic burden of HF on health care systems is substantial. Heart failure with reduced ejection fraction (HFrEF) represents approximately 50% of the HF patient population.The burden of HF is expected to increase substantially as the population ages, and despite improvements in treatment, hospitalisation and mortality rates remain especially high in HFrEF patients. The current guideline recommendation of directed medical therapy for HFrEF combines four drug classes with proven prognostic benefit: Angiotensin receptor-neprilysin inhibitor (ARNI)/angiotensin converting enzyme inhibitors (ACE I)/angiotensin receptor blockers (ARB), betablockers (BB), mineralocorticoid receptor antagonists (MRA), and sodium-glucose co-transporter 2 inhibitors (SGLT2i). The 2023 ESC (European Society of Cardiology) HF guideline update additionally recommends a rapid in-hospital sequencing approach of guideline-directed medical therapy (GDMT) with frequent physician visits during the first 6 weeks post discharge. Studies investigating the implementation of GDMT in a real-world setting have shown that a significant proportion of patients did not receive the recommended drug combination therapy. Delayed initiation of GDMT contributes to the low number of patients receiving guideline concordant HFrEF therapy, which ultimately may affect patient outcomes. One approach to implement the 2023 ESC guideline updates for heart failure treatment regarding early in-hospital initiation and rapid up-titration of GDMT could be to provide specific training on GDMT recommendations. Such a standardised training is offered to the physicians treating HF patients within selected hospitals of the German Helios hospital network (Helios-GDMT-program). Evidence is needed in order to assess whether in-hospital initiation and up-titration of all phenotype concordant classes of GDMT at hospital discharge can be observed after standardised physician training and whether the GDMT-program implementation also translates into real-world routine outpatient care with respect to use of GDMT and clinical outcomes.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 338 (tényleges)
- Első benyújtás
- 2024. szept. 20.
- Kezdés
- 2024. nov. 15.
- Elsődleges befejezés
- 2027. jún. 30.
- Fő szponzor
- AstraZeneca
- Betegségek
- Szívelégtelenség
- NCT-szám
- NCT06675552
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 338
- 2024. nov. 15. és az elsődleges befejezés (2027. jún. 30.) között
- 6 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- Status post heart transplantation
- History of intolerance to one or more GDMT drug classes (ACE-I/ARNI/ARB, BB, MRA, SGLT2i) or significant side effects that led to the discontinuation of two or more substances within one drug class (except from ACE-I/ARB, e.g., if 2 different ACE inhibitors triggered cough, but sartans are tolerated, then the patient is not excluded)
Egyéb
- Initial presentation (index hospitalisation) in cardiogenic shock or other kinds of shock
- Current or planned participation in a clinical trial
- Decision by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures
- Pregnancy or breast-feeding
Kiket keres a vizsgálat
- Age ≥18 years at the time of signing the informed consent
- Hospitalised in a participating site and receiving full inpatient treatment (at least 24h hospital stay)
- Diagnosis of HFrEF according to the current guidelines of the European Society of Cardiology (ESC) with a left ventricular EF of ≤40% (as measured per echocardiography during the index hospital stay or within 3 months prior to index hospitalisation with available reports from imaging (ejection fraction) at the time of study inclusion)
- Treated with a maximum of 2 of the indicated drug classes (ACE-I/ARNI/ARB, BB, MRA, SGLT2i) according to guideline recommendation (GDMT) at admission.
- Signed and dated written informed consent prior to enrolment in the study
- Willing and capable to fulfil requirements listed in the ICF
Életkor a regiszterben: 18 év – 130 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (6)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| - | Berlin | Németország | Ismeretlen állapot |
| - | Erfurt | Németország | Ismeretlen állapot |
| - | Gifhorn | Németország | Ismeretlen állapot |
| - | Leipzig | Németország | Ismeretlen állapot |
| - | Schwerin | Németország | Ismeretlen állapot |
| - | Wuppertal | Németország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.