CRF2 Agonist for the Treatment of Worsening Heart Failure

Launched by CORTERIA PHARMACEUTICALS · Feb 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying an experimental drug called COR-1167 to see how it can help patients who are in the hospital due to worsening heart failure. Heart failure is a condition where the heart struggles to pump blood effectively, and it can lead to serious health issues. The trial aims to learn more about how this new medication works for those who have recently been hospitalized for heart failure and are dealing with fluid overload, which means they have too much fluid in their bodies.

To participate in this study, you need to be between the ages of 65 and 74, have been hospitalized for heart failure in the past year, and have been receiving specific treatments for your condition, such as a type of medication known as a diuretic. If you qualify and decide to join, you'll be closely monitored during the trial to assess how the drug affects your heart failure. It's important to note that this study is not yet recruiting participants, but the research team is looking for individuals who meet the eligibility criteria to help improve treatments for heart failure in the future.

Gender

ALL

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