Worsening Heart Failure
Conditions
Keywords
COR-1167, Hospitalised heart failure, WHF
Brief summary
This study assesses the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure (HF)
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
Interventions
DRUGCOR-1167
28-day treatment
DRUGPlacebo
28-day treatment
Sponsors
Corteria Pharmaceuticals
Worldwide Clinical Trials
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor CRO
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Natriuresis | 24 hours | Urinary sodium excretion |
| Body weight | 7 days | Changes in body weight |
| NT-proBNP | 7 days | Changes in NT-proBNP |
| Kansas City Cardiomyopathy Questionnaire (KCCQ)-Total Symptom Score (TSS) | 28 days | Changes in KCCQ-TSS - The score ranges from 0 to 100 with higher score indicating a better health status |
| Left Atrial Volume index (LAVi) | 2 days | Changes in LAVi - LAV-i is an index of cardiac function measured by echocardiogram |
Countries
Czechia, Georgia, Hungary, Poland, Romania, Serbia, Spain, United States
Contacts
STUDY_CHAIRJeffrey Testani, MD
Yale University
Outcome results
None listed