CRF2 Agonist for the Treatment of Worsening Heart Failure (CRAFT-WHF)

July 21, 2026 updated by: Corteria Pharmaceuticals

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)

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 62500
        • Fakultni nemocnice Brno
      • Krnov, Czechia, 79401
        • Sdružené zdravotnické zařízení Krnov
      • Ostrava, Czechia, 70852
        • Fakultni Nemocnice Ostrava
      • Slaný, Czechia, 27401
        • Nemocnice Slany
  • Georgia
      • Tbilisi, Georgia, 0102
        • Aleksandre Aladashvili Clinic LLC
      • Tbilisi, Georgia, 0186
        • LTD Tbilisi Heart Center
      • Tbilisi, Georgia, 0159
        • Bokhua Memorial CardioVascular Center LTD
      • Tbilisi, Georgia, 0159
        • Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical Research
      • Tbilisi, Georgia, 0112
        • LTD "Israeli-Georgian Medical Research Clinic Healthycore"
      • Tbilisi, Georgia, 0159
        • Acad. G.Chapidze Emergency Cardiology Center, LTD, Department of Multi-center Clinical Trials
      • Tbilisi, Georgia, 0159
        • St. Michael's Hospital LLC
      • Tbilisi, Georgia, 0159
        • Tbilisi Heart and Vascular Clinic, LTD
      • Tbilisi, Georgia, 0167
        • Georgian Dutch Hospital
  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweis Egyetem, Általános Orvostudományi Kar, Városmajori Szív- és Érgyógyászati Klinika
      • Budapest, Hungary, 1145
        • Budapesti Uzsoki Utcai Kórház, Kardiológia Osztály
      • Pécs, Hungary, 7624
        • Pécsi Tudományegyetem, Klinikai Központ, I. sz. Belgyógyászati Klinika
      • Szeged, Hungary, 7625
        • Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet
      • Zalaegerszeg, Hungary, 8900
        • Zala Vármegyei Szent Rafael Kórház, Kardiológiai Osztály
  • Poland
      • Bialystok, Poland, 15-276
        • Klinika Kardiologii i Chorób Wewnętrznych z Oddziałem Intensywnego Nadzoru Kardiologicznego (OINK), Uniwersytecki Szpital Kliniczny w Białymstoku
      • Gdansk, Poland, 80-214
        • I Klinika Kardiologii, Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 30-688
        • SP ZOZ Szpital Uniwersytecki w Krakowie
      • Kłodzko, Poland, 57-300
        • Zespół Opieki Zdrowotnej w Klodzku, Oddzial Kardiologii
      • Lodz, Poland, 92-213
        • II Klinika Kardiologii, SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
      • Rzeszów, Poland, 35-301
        • Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
      • Torun, Poland, 87-100
        • Oddział Kliniczny Kardiologii i Intensywnej Terapii Kardiologicznej
      • Wroclaw, Poland, 50-556
        • Instytut Chorób Serca, Zakład Badań Klinicznych Chorób Układu Krążenia, Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
  • Romania
      • Arad, Romania, 310037
        • Emergency County Clinical Hospital Arad, Cardiology department
      • Bucharest, Romania, 20125
        • Spitalul Clinic Colentina
      • Bucharest, Romania, 022328
        • Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Cardiologie 1
      • Bucharest, Romania, 022328
        • Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Cardiologie 3
      • Craiova, Romania, 200642
        • Craiova County Emergency Clinical Hospital
      • Timișoara, Romania, 300079
        • Spitalul Clinic Municipal de Urgenta Timisoara
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Cardiovascular diseases Dedinje
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center "Dr Dragisa Misovic Dedinje"
      • Belgrade, Serbia, 11000
        • University Clinical Center of Serbia, Clinic for Cardiology, Department for the testing and treatment of congenital and acquired heart defects
      • Belgrade, Serbia, 11000
        • University Clinical Center of Serbia, Clinic for Cardiology, Emergency Cardiology Department
      • Belgrade, Serbia, 11000
        • University Clinical Center of Serbia, Clinic for Cardiology, Heart Failure Ward
      • Kragujevac, Serbia, 34000
        • University Clinical Center Kragujevac, Clinic for Cardiology
      • Leskovac, Serbia, 16000
        • General Hospital Leskovac, Cardiology Department
      • Niš, Serbia, 18000
        • University Clinical Center Nis, Clinic for Cardiology
      • Niška Banja, Serbia, 18205
        • Institute For Treatment and Rehabilitation "Niska Banja"
  • Spain
      • Seville, Spain, 41013
        • Hospital Universitario Hospital Virgen del Rocío
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic La Fe
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario De Valencia
    • Madrid
      • Fuencarral-El Pardo, Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de La Arrixaca
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Methodist Hospital
    • Michigan
      • Detroit, Michigan, United States, 48235
        • Wayne State University - Sinai Grace Hospital
      • Detroit, Michigan, United States, 48201
        • Wayne State University - Detroit Receiving Hospital
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Cone Health Moses Cone Hospital
      • Raleigh, North Carolina, United States, 27607
        • NC Heart and Vascular Research, LLC
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • South Oklahoma Heart Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
28-day treatment
Experimental: COR-1167 low dose
Drug: COR-1167
28-day treatment
Experimental: COR-1167 intermediate dose
Drug: COR-1167
28-day treatment
Experimental: COR-1167 high dose
Drug: COR-1167
28-day treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Natriuresis
Time Frame: 24 hours
Urinary sodium excretion
24 hours
Body weight
Time Frame: 7 days
Changes in body weight
7 days
NT-proBNP
Time Frame: 7 days
Changes in NT-proBNP
7 days
Kansas City Cardiomyopathy Questionnaire (KCCQ)-Total Symptom Score (TSS)
Time Frame: 28 days
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)
Time Frame: 2 days
Changes in LAVi - LAV-i is an index of cardiac function measured by echocardiogram
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corteria Pharmaceuticals

Collaborators

Worldwide Clinical Trials

Investigators

  • Study Chair: Jeffrey Testani, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

February 7, 2025

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COR1167-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is not a phase 3 trial that would benefit from IPD sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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