RECRUITING

CRF2 Agonist for the Treatment of Worsening Heart Failure

Conditions

Worsening Heart Failure COR-1167 Hospitalised heart failure WHF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Corticotrophin Releasing Factor 2 for the Treatment of Worsening Heart Failure (WHF) - The CRAFT-WHF Study

Quick Facts

Study Start:2025-08-07

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06815471

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.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Corteria Chief Medical Officer

CONTACT

610-787-2998

francesca.lawson@corteriapharma.com

Clinical Operations Director

CONTACT

Brian.Sontag@Corteriapharma.com

Principal Investigator

Jeffrey Testani, MD

STUDY_CHAIR

Yale University

Study Locations (Sites)

South Oklahoma Heart Research, LLC

Oklahoma City, Oklahoma, 73135

United States

Collaborators and Investigators

Sponsor: Corteria Pharmaceuticals

Jeffrey Testani, MD, STUDY_CHAIR, Yale University

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 Registration Dates

Study Start Date2025-08-07

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-08-07

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

COR-1167
Hospitalised heart failure
WHF

Additional Relevant MeSH Terms

Worsening Heart Failure