To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)
- Conditions
- Heart FailureWorsening Heart Failure (WHF)
- Registration Number
- NCT06264310
- Lead Sponsor
- River 2 Renal Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria:<br><br> 1. Able and willing to give written informed consent, and able to follow instructions<br> and comply with follow-up procedures.<br><br> 2. History of symptomatic HF (heart failure).<br><br> 3. Male or female = 18 years of age at screening.<br><br> 4. Previous hospitalization for HF within the last 12 months prior to screening.<br><br> 5. Patients on optimal background therapy as per local practice for at least 30 days<br> prior to screening and tolerating this well.<br><br> 6. Patients must present with at least 2 of the following signs / symptoms of<br><br> WHF congestion:<br><br> 1. Dyspnea<br><br> 2. Orthopnea<br><br> 3. Fatigue<br><br> 4. Jugular venous distension<br><br> 5. Rales<br><br> 6. Edema<br><br> 7. Patient requires intensification (doubling the dose, adding another diuretic<br> targeting another tubular segment) of oral diuretics, or IV diuresis for WHF as per<br> Investigator at screening and treated as an outpatient patient.<br><br> 8. Estimated Glomerular Filtration Rate (eGFR) between 20 and 75 mL/ min/1.73 m2<br> (calculated using the CKD-EPI equation) at screening.<br><br> 9. NT-pro-BNP levels at screening:<br><br> 1. = 1000 pg/mL for patients with LVEF = 40%<br><br> 2. = 700 pg/mL for patients with LVEF > 40%<br><br> 3. = 1500 pg/mL for patients with current atrial fibrillation, regardless of LVEF.<br> For patients with BMI = 30 kg/m2 the NT-pro-BNP values are lowered by 20%. The<br> values are as follows:<br><br> <br><br> 1. = 800 pg/mL for patients with LVEF = 40%<br><br> 2. = 560 pg/mL for patients with LVEF > 40%<br><br> 3. = 1200 pg/mL for patients with current atrial fibrillation, regardless of LVEF.<br> The most recent LVEF value assessed in the 12 months prior to screening should<br> be used.<br><br> 10. Systolic Blood Pressure (SBP) = 105 mmHg at screening.<br><br> 11. Willing and able to stay in the clinic for observation/monitoring for 3 days.<br><br> 12. Willing to self-administer all SC injections.<br><br>Exclusion Criteria:<br><br> 1. Patients with blood pressure > 180 mmHg or persistent heart rate > 130 bpm at<br> Screening.<br><br> 2. History of symptomatic hypotension.<br><br> 3. History of orthostatic hypotension.<br><br> 4. Temperature > 38.5°C (oral or equivalent) or sepsis or active infection requiring<br> antimicrobial treatment.<br><br> 5. Clinical evidence of acute coronary syndrome (ACS) currently or within 30 days prior<br> to Screening.<br><br> 6. Acute Heart Failure (AHF) due to significant arrhythmias, which include any of the<br> following: sustained ventricular tachycardia, bradycardia with sustained ventricular<br> rate < 45 bpm or atrial fibrillation/flutter with sustained ventricular response of<br> > 130 bpm.<br><br> 7. The daily use of IV or oral steroids (including but not limited to the use of IV or<br> oral steroids for respiratory disorders or COPD). Note, inhaled steroids are<br> allowed.<br><br> 8. IV antimicrobial treatment for sepsis or active infection.<br><br> 9. Patients with severe renal impairment defined at Screening eGFR < 20 mL/min/1.73m2<br> (calculated using the CKD-EPI Equation), and/or those receiving current or planned<br> dialysis or ultrafiltration.<br><br> 10. Patients with hemoglobin < 10 g/dL, or a history of blood transfusion within the 14<br> days prior to screening, or active life-threatening gastrointestinal bleeding.<br><br> 11. Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased<br> ammonia levels, if performed) or history of cirrhosis with evidence of portal<br> hypertension such as varices.<br><br> 12. Significant, uncorrected, left ventricular outflow obstruction, such as obstructive<br> hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area < 1.0<br> cm2 or mean gradient > 40 mmHg on echocardiogram), and/or severe mitral stenosis.<br><br> 13. Severe aortic insufficiency or severe mitral regurgitation for which surgical or<br> percutaneous intervention is indicated.<br><br> 14. Documented, prior to or at the time of screening, restrictive amyloid<br> myocardiopathy, or acute myocarditis or hypertrophic obstructive, restrictive, or<br> constrictive cardiomyopathy.<br><br> 15. Any major solid organ transplant recipient or planned/ anticipated organ transplant<br> within 1 year.<br><br> 16. Major surgery, including implantable devices (e.g., implantable cardioverter<br> defibrillator, cardiac resynchronization therapy), or major neurologic event<br> including cerebrovascular events, within 30 days prior to screening.<br><br> 17. History of malignancy of any organ system (other than localized basal cell carcinoma<br> of the skin), treated or untreated, within the past year with a current life<br> expectancy less than 1 year due to the malignancy.<br><br> 18. Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a<br> female after conception and until the termination of gestate, confirmed by a<br> positive human chorionic gonadotropin laboratory test.<br><br> 19. Use of other investigational drugs within 30 days prior to Screening.<br><br> 20. History of known hypersensitivity/prior exposure to R2R01 or serelaxin.<br><br> 21. Any other medical condition(s) that might put the patient at risk or influence study<br> results in the Investigator's opinion, or that the Investigator deems unsuitable for<br> the study including drug or alcohol abuse or psychiatric, behavioral, or cognitive<br> disorders sufficient to interfere with the patient's ability to understand and<br> comply with the protocol instructions or follow-up procedures.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0.;Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0.
- Secondary Outcome Measures
Name Time Method