CRF2 Agonist for the Treatment of Worsening Heart Failure
Megadott ok: The DSMB recommended pausing the enrollment to give time to the Executive Committee to revise the eligibility criteria to exclude patients who may be in impending cardiogenic shock or in other ways too ill to safely participate in the trial.
Key facts
- Where
- Budapest XII, Budapest XIII, Budapest XIV, Pécs, Szeged és Zalaegerszeg, MagyarországSee the 6 sites
- Phase
- 2. fázis
Where in Magyarország
- Semmelweis UniversityBudapest XII, MagyarországNo longer taking part
- Central Hospital Of Northern Pest Military HospitalBudapest XIII, MagyarországNo longer taking part
- Budapesti Uzsoki Utcai KorhazBudapest XIV, MagyarországNo longer taking part
- University of PecsPécs, MagyarországNo longer taking part
- University of SzegedSzeged, MagyarországNo longer taking part
- Zala Varmegyei Szent Rafael KorhazZalaegerszeg, MagyarországNo longer taking part
Trial details
- Who runs it
- Corteria Pharmaceuticals
- Trial code
- NCT06815471EU 2024-518951-52-00
- Record updated
- 2026. július 22.
- Original description
This study assesses the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure (HF)Read full original descriptionShow less
Corticotrophin Releasing Factor 2 for the Treatment of Worsening Heart Failure (WHF) - The CRAFT-WHF Study
This study assesses the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure (HF)
Inclusion: Signed written informed consent; Heart failure hospitalization (HFH) during previous 12 months; Prescribed an oral loop diuretic for at least 1 month preceding the index event; NT-proBNP ≥1,000 pg/mL or BNP ≥250 pg/mL; Requires treatment with i.v. diuretics for volume overload; At least 1 risk factor for diuretic resistance; Admitted to the hospital not more than 48 hours prior to randomization.
Exclusion: Requirement for i.v. inotropic therapy or i.v. vasodilators, mechanical ventilation, high-flow oxygen therapy, or NIV; CABG, PCI, implantation of CRT, heart valve procedure or any cardiac surgery within 1 month prior to screening or planned during the study; Use of any investigational drug(s) within 5 half-lives of screening; Index event primarily triggered by an acute event (e.g. AMI, PE, arrhythmia); History of solid organ transplant or active on a transplant list; Severe stenotic cardiac valvular disease; Severe chronic pulmonary disease requiring chronic steroid therapy or chronic oxygen therapy (> 2 L/min); At high risk of death (defined as life expectancy ≤1 year) from causes other than heart failure or any disease that, in the opinion of the Investigator, will preclude their safe participation in this study, and will make implementation of the protocol or interpretation of the study results difficult; Presence of any other conditions (e.g. geographic, social) actual or anticipated, that the Investigator feels would restrict or limit the subject's participation or compliance with all study procedures Subject is the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study; eGFR < 20 mL/min/1.73 m2; Requirement for, or planned use of LVADs, IABP, or any type of MCS; SBP <100 mmHg; Uncorrected severe hyperthyroidism or hypothyroidism; Severe restrictive, obstructive, or infiltrative cardiomyopathy; Body weight < 70 kg.