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CRF2 Agonist for the Treatment of Worsening Heart Failure

NCT06815471 · Corteria Pharmaceuticals
In plain English

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Official title
Corticotrophin Releasing Factor 2 for the Treatment of Worsening Heart Failure (WHF) - The CRAFT-WHF Study
About this study
This is a phase 2, randomized, double-blind, placebo-controlled study designed to assess the dose-dependent effects of 3 doses of the corticotropin-releasing factor type 2 (CRF2) peptide agonist, COR-1167, in subjects with WHF, defined as subjects requiring urgent administration of intravenous (i.v.) diuretics due to worsening of signs and symptoms of heart failure (HF) associated with volume overload
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * Index event primarily triggered by an acute event (e.g. AMI, PE, arrhythmia) * Requirement for i.v. inotropic therapy or i.v. vasodilators, mechanical ventilation, high-flow oxygen therapy, or NIV * Requirement for, or planned use of LVADs, IABP, or any type of MCS * History of solid organ transplant or active on a transplant list * SBP \<100 mmHg * eGFR \< 20 mL/min/1.73 m2 * CABG, PCI, implantation of CRT, heart valve procedure or any cardiac surgery within 1 month prior to screening or planned during the study * Severe stenotic cardiac valvular disease * Severe chronic pulmonary disease requiring chronic steroid therapy or chronic oxygen therapy (\> 2 L/min) * Uncorrected severe hyperthyroidism or hypothyroidism * Severe restrictive, obstructive, or infiltrative cardiomyopathy * Body weight \< 70 kg * Use of any investigational drug(s) within 5 half-lives of screening * 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
Study design
Enrollment target: 300 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-08-07
Estimated completion: 2026-12
Last updated: 2026-04-08
Interventions
Drug: COR-1167Drug: Placebo
Primary outcomes
  • Natriuresis (24 hours)
  • Body weight (7 days)
  • NT-proBNP (7 days)
Sponsor
Corteria Pharmaceuticals · industry
With: Worldwide Clinical Trials
Contacts & investigators
ContactCorteria Chief Medical Officer · contact · francesca.lawson@corteriapharma.com · 610-787-2998
ContactClinical Operations Director · contact · Brian.Sontag@Corteriapharma.com
InvestigatorJeffrey Testani, MD · study_chair, Yale University
All locations (55)
Indiana University Health Methodist HospitalNot Yet Recruiting
Indianapolis, Indiana, United States
Wayne State University - Detroit Receiving HospitalNot Yet Recruiting
Detroit, Michigan, United States
Wayne State University - Sinai Grace HospitalNot Yet Recruiting
Detroit, Michigan, United States
Cone Health Moses Cone HospitalNot Yet Recruiting
Greensboro, North Carolina, United States
NC Heart and Vascular Research, LLCRecruiting
Raleigh, North Carolina, United States
Ohio State UniversityRecruiting
Columbus, Ohio, United States
South Oklahoma Heart Research, LLCNot Yet Recruiting
Oklahoma City, Oklahoma, United States
Fakultní nemocnice BrnoNot Yet Recruiting
Brno, Czechia
Sdružené zdravotnické zařízení KrnovNot Yet Recruiting
Krnov, Czechia
Fakultní nemocnice OstravaNot Yet Recruiting
Ostrava, Czechia
Nemocnice SlanýRecruiting
Slaný, Czechia
Aleksandre Aladashvili Clinic LLCRecruiting
Tbilisi, Georgia
LTD "Israeli-Georgian Medical Research Clinic Healthycore"Recruiting
Tbilisi, Georgia
Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical ResearchRecruiting
Tbilisi, Georgia
Acad. G.Chapidze Emergency Cardiology Center, LTD, Department of Multi-center Clinical TrialsRecruiting
Tbilisi, Georgia
Bokhua Memorial Cardiovascular Center LTDRecruiting
Tbilisi, Georgia
St. Michael's Hospital LLCRecruiting
Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic, LTDRecruiting
Tbilisi, Georgia
Georgian Dutch HospitalRecruiting
Tbilisi, Georgia
LTD Tbilisi Heart CenterRecruiting
Tbilisi, Georgia
Semmelweis Egyetem, Általános Orvostudományi Kar, Városmajori Szív- és Érgyógyászati KlinikaRecruiting
Budapest, Hungary
Budapesti Uzsoki Utcai Kórház, Kardiológia OsztályNot Yet Recruiting
Budapest, Hungary
Pécsi Tudományegyetem, Klinikai Központ, I. sz. Belgyógyászati KlinikaNot Yet Recruiting
Pécs, Hungary
Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi IntézetNot Yet Recruiting
Szeged, Hungary
Zala Vármegyei Szent Rafael Kórház, Kardiológiai OsztályNot Yet Recruiting
Zalaegerszeg, Hungary
Klinika Kardiologii i Chorób Wewnętrznych z Oddziałem Intensywnego Nadzoru Kardiologicznego (OINK), Uniwersytecki Szpital Kliniczny w BiałymstokuRecruiting
Bialystok, Poland
I Klinika Kardiologii, Uniwersyteckie Centrum KliniczneNot Yet Recruiting
Gdansk, Poland
SP ZOZ Szpital Uniwersytecki w KrakowieNot Yet Recruiting
Krakow, Poland
Zespół Opieki Zdrowotnej w Klodzku, Oddzial KardiologiiNot Yet Recruiting
Kłodzko, Poland
II Klinika Kardiologii, SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w LodziNot Yet Recruiting
Lodz, Poland
Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w RzeszowieNot Yet Recruiting
Rzeszów, Poland
Oddział Kliniczny Kardiologii i Intensywnej Terapii KardiologicznejNot Yet Recruiting
Torun, Poland
Instytut Chorób Serca, Zakład Badań Klinicznych Chorób Układu Krążenia, Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we WrocławiuRecruiting
Wroclaw, Poland
Emergency County Clinical Hospital Arad, Cardiology departmentNot Yet Recruiting
Arad, Romania
Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Cardiologie 1Not Yet Recruiting
Bucharest, Romania
Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Cardiologie 3Not Yet Recruiting
Bucharest, Romania
Spitalul Clinic ColentinaNot Yet Recruiting
Bucharest, Romania
Craiova County Emergency Clinical HospitalRecruiting
Craiova, Romania
Spitalul Clinic Municipal de Urgenta TimisoaraNot Yet Recruiting
Timișoara, Romania
Clinical Hospital Center "Dr Dragisa Misovic Dedinje"Not Yet Recruiting
Belgrade, Serbia
Institute for Cardiovascular Diseases DedinjeNot Yet Recruiting
Belgrade, Serbia
University Clinical Center of Serbia, Clinic for Cardiology, Department for the testing and treatment of congenital and acquired heart defectsNot Yet Recruiting
Belgrade, Serbia
University Clinical Center of Serbia, Clinic for Cardiology, Emergency Cardiology DepartmentRecruiting
Belgrade, Serbia
University Clinical Center of Serbia, Clinic for Cardiology, Heart Failure WardNot Yet Recruiting
Belgrade, Serbia
University Clinical Center Kragujevac, Clinic for CardiologyNot Yet Recruiting
Kragujevac, Serbia
General Hospital Leskovac, Cardiology DepartmentWithdrawn
Leskovac, Serbia
University Clinical Center Nis, Clinic for CardiologyRecruiting
Niš, Serbia
Institute For Treatment and Rehabilitation "Niska Banja"Not Yet Recruiting
Niška Banja, Serbia
Hospital Universitario Ramon y CajalNot Yet Recruiting
Fuencarral-El Pardo, Madrid, Spain
Hospital Universitario Puerta de Hierro MajadahondaNot Yet Recruiting
Majadahonda, Madrid, Spain
Hospital Clínico Universitario Virgen de la ArrixacaNot Yet Recruiting
El Palmar, Murcia, Spain
Hospital Clínico Universitario de ValenciaRecruiting
Valencia, Valencia, Spain
Hospital Universitario Hospital Virgen del RocíoRecruiting
Seville, Spain
Consorcio Hospital General Universitario de ValenciaNot Yet Recruiting
Valencia, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Spain
CRF2 Agonist for the Treatment of Worsening Heart Failure · TrialPath