CRF2 Agonist for the Treatment of Worsening Heart Failure

NCT06815471 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: COR1167-201
• Study Type: interventional
• Target: 300
• Locations: 8 countries
• Sites: 55

Brief Summary

This study assesses the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure (HF)

Conditions

Worsening Heart Failure

Keywords

COR-1167; Hospitalised heart failure; WHF

Outcome Measures

Primary Outcomes (5)

• Natriuresis

  Urinary sodium excretion

  24 hours

• Body weight

  Changes in body weight

  7 days

• NT-proBNP

  Changes in NT-proBNP

  7 days

• Kansas City Cardiomyopathy Questionnaire (KCCQ)-Total Symptom Score (TSS)

  Changes in KCCQ-TSS - The score ranges from 0 to 100 with higher score indicating a better health status

  28 days

• Left Atrial Volume index (LAVi)

  Changes in LAVi - LAV-i is an index of cardiac function measured by echocardiogram

  2 days

Study Arms (4)

COR-1167 low dose

EXPERIMENTAL

Drug: COR-1167

COR-1167 intermediate dose

EXPERIMENTAL

Drug: COR-1167

COR-1167 high dose

EXPERIMENTAL

Drug: COR-1167

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

COR-1167 DRUG

28-day treatment

COR-1167 high dose; COR-1167 intermediate dose; COR-1167 low dose

Placebo DRUG

28-day treatment

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corteria Pharmaceuticals: lead
• Worldwide Clinical Trials: collaborator

Study Sites (55)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

Wayne State University - Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

NOT YET RECRUITING

Wayne State University - Sinai Grace Hospital

Detroit, Michigan, 48235, United States

NOT YET RECRUITING

Cone Health Moses Cone Hospital

Greensboro, North Carolina, 27401, United States

NOT YET RECRUITING

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

South Oklahoma Heart Research, LLC

Oklahoma City, Oklahoma, 73135, United States

NOT YET RECRUITING

Fakultní nemocnice Brno

Brno, 62500, Czechia

NOT YET RECRUITING

Sdružené zdravotnické zařízení Krnov

Krnov, 79401, Czechia

NOT YET RECRUITING

Fakultní nemocnice Ostrava

Ostrava, 70852, Czechia

NOT YET RECRUITING

Nemocnice Slaný

Slaný, 27401, Czechia

RECRUITING

Aleksandre Aladashvili Clinic LLC

Tbilisi, 0102, Georgia

RECRUITING

LTD "Israeli-Georgian Medical Research Clinic Healthycore"

Tbilisi, 0112, Georgia

RECRUITING

Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical Research

Tbilisi, 0159, Georgia

RECRUITING

Acad. G.Chapidze Emergency Cardiology Center, LTD, Department of Multi-center Clinical Trials

Tbilisi, 0159, Georgia

RECRUITING

Bokhua Memorial Cardiovascular Center LTD

Tbilisi, 0159, Georgia

RECRUITING

St. Michael's Hospital LLC

Tbilisi, 0159, Georgia

RECRUITING

Tbilisi Heart and Vascular Clinic, LTD

Tbilisi, 0159, Georgia

RECRUITING

Georgian Dutch Hospital

Tbilisi, 0167, Georgia

RECRUITING

LTD Tbilisi Heart Center

Tbilisi, 0186, Georgia

RECRUITING

Semmelweis Egyetem, Általános Orvostudományi Kar, Városmajori Szív- és Érgyógyászati Klinika

Budapest, 1122, Hungary

RECRUITING

Budapesti Uzsoki Utcai Kórház, Kardiológia Osztály

Budapest, 1145, Hungary

NOT YET RECRUITING

Pécsi Tudományegyetem, Klinikai Központ, I. sz. Belgyógyászati Klinika

Pécs, 7624, Hungary

NOT YET RECRUITING

Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet

Szeged, 7625, Hungary

NOT YET RECRUITING

Zala Vármegyei Szent Rafael Kórház, Kardiológiai Osztály

Zalaegerszeg, 8900, Hungary

NOT YET RECRUITING

Klinika Kardiologii i Chorób Wewnętrznych z Oddziałem Intensywnego Nadzoru Kardiologicznego (OINK), Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, 15-276, Poland

RECRUITING

I Klinika Kardiologii, Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

NOT YET RECRUITING

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

NOT YET RECRUITING

Zespół Opieki Zdrowotnej w Klodzku, Oddzial Kardiologii

Kłodzko, 57-300, Poland

NOT YET RECRUITING

II Klinika Kardiologii, SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, 92-213, Poland

NOT YET RECRUITING

Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie

Rzeszów, 35-301, Poland

NOT YET RECRUITING

Oddział Kliniczny Kardiologii i Intensywnej Terapii Kardiologicznej

Torun, 87-100, Poland

NOT YET RECRUITING

Instytut Chorób Serca, Zakład Badań Klinicznych Chorób Układu Krążenia, Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, 50-556, Poland

RECRUITING

Emergency County Clinical Hospital Arad, Cardiology department

Arad, 310037, Romania

NOT YET RECRUITING

Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Cardiologie 1

Bucharest, 022328, Romania

NOT YET RECRUITING

Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Cardiologie 3

Bucharest, 022328, Romania

NOT YET RECRUITING

Spitalul Clinic Colentina

Bucharest, 20125, Romania

NOT YET RECRUITING

Craiova County Emergency Clinical Hospital

Craiova, 200642, Romania

RECRUITING

Spitalul Clinic Municipal de Urgenta Timisoara

Timișoara, 300079, Romania

NOT YET RECRUITING

Clinical Hospital Center "Dr Dragisa Misovic Dedinje"

Belgrade, 11000, Serbia

NOT YET RECRUITING

Institute for Cardiovascular Diseases Dedinje

Belgrade, 11000, Serbia

NOT YET RECRUITING

University Clinical Center of Serbia, Clinic for Cardiology, Department for the testing and treatment of congenital and acquired heart defects

Belgrade, 11000, Serbia

NOT YET RECRUITING

University Clinical Center of Serbia, Clinic for Cardiology, Emergency Cardiology Department

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center of Serbia, Clinic for Cardiology, Heart Failure Ward

Belgrade, 11000, Serbia

NOT YET RECRUITING

University Clinical Center Kragujevac, Clinic for Cardiology

Kragujevac, 34000, Serbia

NOT YET RECRUITING

General Hospital Leskovac, Cardiology Department

Leskovac, 16000, Serbia

WITHDRAWN

University Clinical Center Nis, Clinic for Cardiology

Niš, 18000, Serbia

RECRUITING

Institute For Treatment and Rehabilitation "Niska Banja"

Niška Banja, 18205, Serbia

NOT YET RECRUITING

Hospital Universitario Ramon y Cajal

Fuencarral-El Pardo, Madrid, 28034, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

NOT YET RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

NOT YET RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

Hospital Universitario Hospital Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Consorcio Hospital General Universitario de Valencia

Valencia, 46014, Spain

NOT YET RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Related Publications (6)

• Rademaker MT, Charles CJ, Ellmers LJ, Lewis LK, Nicholls MG, Richards AM. Prolonged urocortin 2 administration in experimental heart failure: sustained hemodynamic, endocrine, and renal effects. Hypertension. 2011 Jun;57(6):1136-44. doi: 10.1161/HYPERTENSIONAHA.111.173203. Epub 2011 May 2.

  PMID: 21536988 RESULT

• Rademaker MT, Charles CJ, Nicholls MG, Richards AM. Urocortin 2 inhibits furosemide-induced activation of renin and enhances renal function and diuretic responsiveness in experimental heart failure. Circ Heart Fail. 2009 Nov;2(6):532-40. doi: 10.1161/CIRCHEARTFAILURE.109.861336. Epub 2009 Sep 22.

  PMID: 19919977 RESULT

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

  PMID: 27207191 RESULT

• Chan WY, Frampton CM, Crozier IG, Troughton RW, Richards AM. Urocortin-2 infusion in acute decompensated heart failure: findings from the UNICORN study (urocortin-2 in the treatment of acute heart failure as an adjunct over conventional therapy). JACC Heart Fail. 2013 Oct;1(5):433-41. doi: 10.1016/j.jchf.2013.07.003. Epub 2013 Sep 11.

  PMID: 24621976 RESULT

• Rubio-Gracia J, Demissei BG, Ter Maaten JM, Cleland JG, O'Connor CM, Metra M, Ponikowski P, Teerlink JR, Cotter G, Davison BA, Givertz MM, Bloomfield DM, Dittrich H, Damman K, Perez-Calvo JI, Voors AA. Prevalence, predictors and clinical outcome of residual congestion in acute decompensated heart failure. Int J Cardiol. 2018 May 1;258:185-191. doi: 10.1016/j.ijcard.2018.01.067.

  PMID: 29544928 RESULT

• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.

  PMID: 24446411 RESULT

Study Officials

• Jeffrey Testani, MD

  Yale University

  STUDY CHAIR

Central Study Contacts

Corteria Chief Medical Officer

CONTACT

610-787-2998; francesca.lawson@corteriapharma.com

Clinical Operations Director

CONTACT

Brian.Sontag@Corteriapharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor CRO
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (6); US (7); GE (9); SE (9); PL (8); HU (5); CZ (4); ES (7)