To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC A⌠(NCT06264310) | Clinical Trial Compass
CompletedPhase 2
To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)
United States33 participantsStarted 2024-03-01
Plain-language summary
This Study Aims to Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
â. Able and willing to give written informed consent, and able to follow instructions and comply with follow-up procedures.
â. History of symptomatic HF (heart failure).
â. Male or female ⼠18 years of age at screening.
â. Previous hospitalization for HF within the last 12 months prior to screening.
â. Patients on optimal background therapy as per local practice for at least 30 days prior to screening and tolerating this well.
â. Patients must present with at least 2 of the following signs / symptoms of
â. Dyspnea
â. Orthopnea
Exclusion criteria
â. Patients with blood pressure \> 180 mmHg or persistent heart rate \> 130 bpm at Screening.
â. History of symptomatic hypotension.
â. History of orthostatic hypotension.
â. Temperature \> 38.5°C (oral or equivalent) or sepsis or active infection requiring antimicrobial treatment.
â. Clinical evidence of acute coronary syndrome (ACS) currently or within 30 days prior to Screening.
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What they're measuring
1
Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0.
Timeframe: Day 7, Day 30
2
Number and rate of patients with one or more TEAEs (treatment emergent AE's) and/or serious TEAEs as assessed by CTCAE v5.0.
. Acute Heart Failure (AHF) due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate \< 45 bpm or atrial fibrillation/flutter with sustained ventricular response of \> 130 bpm.
â. The daily use of IV or oral steroids (including but not limited to the use of IV or oral steroids for respiratory disorders or COPD). Note, inhaled steroids are allowed.
â. IV antimicrobial treatment for sepsis or active infection.