BridgeMD
Corticotrophin Releasing Factor 2 Agonist For the Treatment of Worsening Heart Failure (WHF) – The CRAFT-WHF Study
EU CTIS ID: 2024-518951-52-00
What this study is testing
To evaluate the dose-effect relationship of 3 doses of COR-1167 versus placebo administered once daily (o.d.) subcutaneously (s.c.) for 4 weeks to subjects with worsening heart failure (WHF) on: 1) natriuresis; 2) body weight; 3) levels of N-terminal pro B-type natriuretic peptide (NT-proBNP); 4) Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS); and 5) Left Atrial Volume Index (LAVi).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1) Heart failure hospitalization (HFH) during previous 12 months
- 2) Prescribed an oral loop diuretic for at least 1 month preceding the index event
- 3) NT-proBNP ≥1,000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL
- 4) Requires treatment with i.v. diuretics for volume overload (the index event) defined by the presence of a. clinically significant extravascular volume overload evidenced by pitting edema, ascites, or pleural effusion AND b. ≥1 of the following clinical signs and symptoms of congestion: i. Dyspnea at rest ii. Rales heard on auscultation iii. Pulmonary congestion identified by diagnostic imaging (e.g. interstitial or alveolar edema on chest X-ray or B lines on lung ultrasound) (pleural effusion does not affect the lung parenchyma and cannot be used as a sign of pulmonary congestion) iv. Jugular venous distention
- 5) Risk factors for diuretic resistance
- 6) Unable to procreate or must agree to use a highly effective form of birth control from screening through 30 days after the last dose of study treatment
You likely can't join if
- 1) Age <18 years (or legal age for the country of participation) or >85 years atscreening
- 10) Severe chronic pulmonary disease requiring chronic steroid therapy or chronic oxygen therapy (> 2 L/min)
- 11) Uncorrected severe hyperthyroidism or hypothyroidism. Note: Severe hyperthyroidism refers to persistent symptomatology (e.g. tachycardia, weight loss, tremors, anxiety, sweating, goiter) despite treatment. Severe hypothyroidism refers to persistent symptomatology (e.g. extreme fatigue, weight gain, cold intolerance, constipation, hair loss, voice changes, depression, swelling around the eyes) despite treatment.
- 12) Severe restrictive, obstructive, or infiltrative cardiomyopathy
- 13) Body weight < 70 kg
- 14) Use of any investigational drug(s) within 5 half-lives of screening
See the full eligibility criteria
Who can join
- 1) Heart failure hospitalization (HFH) during previous 12 months
- 2) Prescribed an oral loop diuretic for at least 1 month preceding the index event
- 3) NT-proBNP ≥1,000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL
- 4) Requires treatment with i.v. diuretics for volume overload (the index event) defined by the presence of a. clinically significant extravascular volume overload evidenced by pitting edema, ascites, or pleural effusion AND b. ≥1 of the following clinical signs and symptoms of congestion: i. Dyspnea at rest ii. Rales heard on auscultation iii. Pulmonary congestion identified by diagnostic imaging (e.g. interstitial or alveolar edema on chest X-ray or B lines on lung ultrasound) (pleural effusion does not affect the lung parenchyma and cannot be used as a sign of pulmonary congestion) iv. Jugular venous distention
- 5) Risk factors for diuretic resistance
- 6) Unable to procreate or must agree to use a highly effective form of birth control from screening through 30 days after the last dose of study treatment
- 7) Signed written informed consent to participate in the study in accordance with local regulations
- 8) Admitted to the hospital not more than 48 hours prior to randomization
- 9) In the opinion of the investigator, participant continues to have significant volume overload (≥5 kg) requiring treatment with additional i.v. loop diuretics
What rules you out
- 1) Age <18 years (or legal age for the country of participation) or >85 years atscreening
- 10) Severe chronic pulmonary disease requiring chronic steroid therapy or chronic oxygen therapy (> 2 L/min)
- 11) Uncorrected severe hyperthyroidism or hypothyroidism. Note: Severe hyperthyroidism refers to persistent symptomatology (e.g. tachycardia, weight loss, tremors, anxiety, sweating, goiter) despite treatment. Severe hypothyroidism refers to persistent symptomatology (e.g. extreme fatigue, weight gain, cold intolerance, constipation, hair loss, voice changes, depression, swelling around the eyes) despite treatment.
- 12) Severe restrictive, obstructive, or infiltrative cardiomyopathy
- 13) Body weight < 70 kg
- 14) Use of any investigational drug(s) within 5 half-lives of screening
- 15) 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
- 16) Presence of any other conditions actual or anticipated, that the Investigator feels would restrict or limit the subject’s participation or compliance with all study procedures
- 17) Subject is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study
- 2) Index event primarily triggered by one of the following events: a. pulmonary embolism b. cerebrovascular accident c. acute myocardial infarction d. significant arrhythmia (e.g.,sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular rate <45 beats per minute) e. infection (requiring intravenous antibiotics and/or with fever > 101.5 F / 38.5 C) f. severe anemia (hemoglobin <7g/dl) g. exacerbation of chronic obstructive pulmonary disease (COPD)
- 3) Requirement for i.v. inotropic therapy or i.v. vasodilators (except for nitrates), mechanical ventilation, high-flow oxygen therapy, or noninvasive ventilation (NIV) (use of continuous positive airway pressure [CPAP] for obstructive sleep apnea is allowed)
- 4) Requirement for, or planned use of left ventricular assist devices (LVADs), intra-aortic balloon pump (IABP), or any type of mechanical circulatory support (MCS)
- 5) History of solid organ transplant or active on a transplant list
- 6) Systolic blood pressure (SBP) <100 mmHg at randomization
- 7) Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m2 at screening
- 8) Coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of cardiac resynchronization therapy [CRT]), heart valve procedure or any cardiac surgery within 1 month prior to screening or planned during the study. Note: Remote monitoring devices such as cardioMEMS and implantable cardioverter-defibrillators (ICDs) are not an exclusion.
- 9) Severe stenotic cardiac valvular disease
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Georgia
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Georgia; Serbia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.