Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthost… (NCT06593600) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Natriuretic Peptide Receptor 1 (NPR1) Antagonist in Adult Patients With Postural Orthostatic Tachycardia Syndrome (POTS)
United States, Canada82 participantsStarted 2024-11-13
Plain-language summary
This study is researching an experimental drug called REGN7544 (called "study drug"). The study is focused on participants with POTS.
The aim of the study is to see how safe, tolerable, and effective the study drug is.
The study is looking at several other research questions, including:
* How the study drug changes heart rate and blood pressure in participants with POTS
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
* How the study drug affects symptoms associated with POTS
Who can participate
Age range
18 Years – 55 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
. Is diagnosed with POTS and demonstrates consensus criteria (a), (b), (c) and (d) below during screening:
. Increase in HR ≥30 Beats Per Minute (BPM) within 10 minutes of changing from supine to a standing position, as described in the protocol
. Absence of orthostatic hypotension, defined as a decrease in Systolic Blood Pressure (SBP) \>20 mm Hg within 3 minutes of standing
. Absence of other conditions explaining orthostatic tachycardia in the judgment of the investigator, as defined in the protocol
. Ongoing episodic symptoms consistent with POTS (for example, lightheadedness, palpitations, tremulousness, generalized weakness, blurred vision, and fatigue) that are worse with standing and are relieved by lying down and which have been present for ≥3 months
. During screening, a participant must score ≥3 on the Patient Global Impressions of Severity (PGIS)
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
Change in Heart Rate (HR) from supine to standing (DeltaHR)
. Has a body mass index between 18 and 35 kg/m2, inclusive
Exclusion criteria
. History of hypertension or a seated SBP during screening that is \>140 mm Hg
. SBP during Active Stand (AS) test during screening, either supine or standing, that is \>140 mm Hg systolic on ≥2 measurements
. Increase in HR \<20 BPM within 10 minutes of changing from supine to a standing position, as defined in protocol
. Is judged by the investigator to have significant heart failure, cardiovascular disease, liver disease, or renal disease (ie, estimated Glomerular Filtration Rate (eGFR) \<60 ml/min/1.73m2) based on medical history, physical exam, laboratory studies, and/or electrocardiogram (ECG) performed during screening period
. Is confined to bed more than 50% of waking hours
. Within 5 days of screening visit has used medications with direct effects on blood volume, BP, or HR (eg, midodrine, droxidopa, octreotide, clonidine, methyldopa, ivabradine, beta-blockers, calcium channel blockers, pyridostigmine, fludrocortisone, desmopressin, stimulants or intravenous (IV) saline)