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R2R01 for Heart Failure

Phase 2
Recruiting
Research Sponsored by River 2 Renal Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female ≥ 18 years of age at screening
Willing to self-administer all SC injections
Must not have
Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased ammonia levels, if performed) or history of cirrhosis with evidence of portal hypertension such as varices
Significant, uncorrected, left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area < 1.0 cm2 or mean gradient > 40 mmHg on echocardiogram), and/or severe mitral stenosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7, day 30

Summary

This trial will test if adding a new medication, R2R01, to the standard treatment for worsening heart failure is safe, well-tolerated, and effective when compared to the standard treatment alone

Who is the study for?
Adults with worsening heart failure who have certain levels of NT-pro-BNP, show at least two symptoms like shortness of breath or swelling, and are on stable heart failure medication. They must be able to self-administer injections and stay in the clinic for 3 days. Exclusions include severe kidney problems, recent major surgery or stroke, specific types of cardiomyopathy, high blood pressure or fast heart rate at screening, low hemoglobin levels, known allergies to R2R01 or serelaxin, liver issues, pregnant/nursing women.
What is being tested?
The trial is testing a new treatment called R2R01 combined with standard care (SOC) against SOC alone in outpatients with worsening heart failure. The goal is to see if adding R2R01 improves patient outcomes compared to just using the usual treatments for this condition.
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions similar to other medications used in heart failure such as changes in blood pressure and kidney function; allergic reactions; fatigue; dizziness; gastrointestinal disturbances; and possible injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am willing to give myself subcutaneous injections.
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I experience at least two symptoms like shortness of breath, swelling, or fatigue due to heart failure.
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My kidney function, measured by eGFR, is between 20 and 75 mL/min.
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I have had symptoms of heart failure.
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I can stay in the clinic for 3 days for monitoring.
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I was hospitalized for heart failure in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have liver problems, shown by high bilirubin or ammonia levels, or cirrhosis with portal hypertension.
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I have a severe heart valve problem that hasn't been fixed.
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I have a serious heart valve problem that needs surgery or a procedure.
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I have a history of sudden blood pressure drops when standing up.
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I have heart failure caused by irregular heartbeats.
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I am currently receiving IV antibiotics for sepsis or an infection.
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My hemoglobin is below 10 g/dL, I've had a blood transfusion recently, or I have severe GI bleeding.
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I have severe kidney problems or am on dialysis.
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I have experienced symptoms of low blood pressure.
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I have a documented heart condition such as amyloid myocardiopathy or myocarditis.
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I have had or will have a major organ transplant within a year.
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I have had cancer in the past year with a life expectancy of less than 1 year.
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I have a fever over 38.5°C, sepsis, or an infection needing antibiotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7, day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Change from Baseline on NT-pro-BNP using descriptive and summary statistics by dose level at Day 7 and Day 30.
Change from baseline on Cystatin C and creatinine clearance using descriptive and summary statistics by dose level at Day 7 and Day 30.
Number of all-cause hospitalizations among patients using descriptive and summary statistics for change from baseline by dose level at Day 30.
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 7.5 mg R2R01Experimental Treatment1 Intervention
8 study subjects will receive 7.5 mg R2R01 once daily subcutaneous injection for 7 days.
Group II: 5.0 mg R2R01Experimental Treatment1 Intervention
8 study subjects will receive 5.0 mg R2R01 once daily subcutaneous injection for 7 days.
Group III: 10.0 mg R2R01Experimental Treatment1 Intervention
8 study subjects will receive 10.0 mg R2R01 once daily subcutaneous injection for 7 days.
Group IV: PlaceboPlacebo Group1 Intervention
8 study subjects will receive placebo once daily subcutaneous injection for 7 days.

Find a Location

Who is running the clinical trial?

River 2 Renal Corp.Lead Sponsor
1 Previous Clinical Trials
95 Total Patients Enrolled
International HealthCare, LLCOTHER
1 Previous Clinical Trials
600 Total Patients Enrolled
~3 spots leftby Jan 2025
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