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

Corteria Pharmaceuticals

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Worsening Heart Failure

Treatments: Drug: COR-1167; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06815471

COR1167-201

Details and patient eligibility

About

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

Full description

This is a phase 2b, 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 4 patient groups, including a placebo group

COR-1167 low dose

Experimental group

Treatment:

Drug: COR-1167

COR-1167 intermediate dose

Experimental group

Treatment:

Drug: COR-1167

COR-1167 high dose

Experimental group

Treatment:

Drug: COR-1167

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo