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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able and willing to give written informed consent, and able to follow instructions and comply with follow-up procedures.
. History of symptomatic HF (heart failure).
. Male or female ≥ 18 years of age at screening.
. Previous hospitalization for HF within the last 12 months prior to screening.
. Patients on optimal background therapy as per local practice for at least 30 days prior to screening and tolerating this well.
. Patients must present with at least 2 of the following signs / symptoms of
. Dyspnea
. Orthopnea
Exclusion criteria
. Patients with blood pressure \> 180 mmHg or persistent heart rate \> 130 bpm at Screening.
. History of symptomatic hypotension.
. History of orthostatic hypotension.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. Temperature \> 38.5°C (oral or equivalent) or sepsis or active infection requiring antimicrobial treatment.
. Clinical evidence of acute coronary syndrome (ACS) currently or within 30 days prior to Screening.
. 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.
. 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.
. IV antimicrobial treatment for sepsis or active infection.