Atrial Fibrillation (AF)Phase 1/2Relax-in-AFNCT07359872
Relaxin Therapy for Atrial Fibrillation
A Phase 1/2 study testing Relaxin in people with Atrial Fibrillation (AF) and Arrhythmia, run by Deeptankar DeMazumder.
Trial summary
Atrial fibrillation (AF) is the most common heart rhythm disorder. The presence of AF increases the risk of death and is associated with a 5-6-fold increase in stroke incidence, due almost exclusively to thrombus formation in the heart. Current therapies for AF are limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Arrhythmia, Oxidative Stress
- What is being tested?
- Relaxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosed with AF and scheduled for elective catheter ablation for AF
Who cannot join
- Enrollment in another Greater than Minimal Risk Study
- Pregnant, nursing, or sexually active females not using birth control or having been surgically sterilized
- Females who plan to become pregnant during the trial period
- Patients diagnosed with "permanent" AF, complete heart block, or a reversible cause of AF (e.g., transient thyrotoxicosis)
- Patients that require antiarrhythmic medication to started or continued during and after the ablation procedure.
- Patients unable to tolerate Relaxin therapy or unable or unwilling to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Project Manager contact
About this study
Atrial fibrillation (AF) is the most common heart rhythm disorder. The presence of AF increases the risk of death and is associated with a 5-6-fold increase in stroke incidence, due almost exclusively to thrombus formation in the heart. Current therapies for AF are limited. The evaluation of new, more effective treatments for preventing AF recurrence remains a critical unmet clinical need. AF is considered a progressive disease that increases in prevalence with age and can convert from "paroxysmal" to "persistent" to "permanent" AF in a single individual. This progression results, in part, from high oxidative stress and progressive adverse electrical changes in the heart. Compelling preclinical and clinical data indicate that Relaxin, a naturally occurring peptide hormone, may reverse the electrical remodeling. Thus, our overall objective is to investigate the effects of Relaxin in Veterans who have failed medical management for symptomatic AF and is referred to Cardiac Electrophysiology Laboratory for catheter ablation and pulmonary vein isolation. We will determine whether Relaxin therapy, in addition to the standard of care, counteracts the oxidative stress-related electrical derangement and reduces the post-ablation AF burden. A unique aspect of this proposal is that it is based in part on observations derived from the basic, translational and computational labs of the PI and co-investigators and from the observations by the PI while caring for patients with AF. As such, this proposal represents a true progression from the bench to the bedside. If successful, our findings may lead to the design of a new, more effective treatment for a major unmet public health problem in the United States as well as the world.
- Conditions
- Atrial Fibrillation (AF), Arrhythmia, Oxidative Stress, Stroke, Major Cardiovascular Event, Heart Failure
- Being tested
- Relaxin, Placebo
- Keywords
- randomized controlled crossover trial, Randomized clinical trial
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Stroke, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelaxinDrug
subcutaneous injections of Relaxin once daily
PlaceboDrug
subcutaneous injections of Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (including ablation) + Placebo x 9mo, then crossover to Relaxin therapy x 3mo | Experimental | Patients receiving the standard of care (which includes catheter ablation) will be treatment in a double blinded manner with (1) Placebo for the first 9 months; and then (2) Relaxin, instead of Placebo, for another 3 months. Receives: Drug: Relaxin; Drug: Placebo |
| Standard of care (including ablation) + Relaxin therapy x 9mo, then crossover to Placebo x 3mo | Experimental | Patients receiving the standard of care (which includes catheter ablation) will be treatment in a double blinded manner with (1) Relaxin for the first 9 months; and then (2) Placebo, instead of Relaxin, for another 3 months. Receives: Drug: Relaxin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The Primary Safety Outcome includes the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 390 days
Ratio of the average daily AF burden before and after treatment
The Primary Efficacy Outcome includes the distribution of the ratio of the average daily AF burden before and after treatment over time. The daily AF burden is defined as the daily AF duration multiplied by the number of AF events including atrial ectopy.
Measured: 390 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deeptankar DeMazumder
- Sponsor type
- US federal agency
- Collaborators
- Relaxera Pharmaceuticals, McGowan Institute for Regenerative Medicine, University of Pittsburgh, Relaxera Pharmazeutische Gesellschaft mbH & Co. KG
- Responsible party
- Sponsor-investigator, Deeptankar DeMazumder, VA Pittsburgh Healthcare System
- Investigators
- Deeptankar DeMazumder, MD, PhD, Principal investigator, (1) VA Pittsburgh Health System; (2) McGowan Institute for Regenerative Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359872
- Sponsor's protocol ID
- 1923002
- Acronym
- Relax-in-AF
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared as allowed by applicable VA, state, federal and IP rules and policies.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxin Therapy for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07359872
- Acronym / sponsor ID
- Relax-in-AF / 1923002
- Conditions
- Atrial Fibrillation (AF), Arrhythmia, Oxidative Stress, Stroke, Major Cardiovascular Event, Heart Failure
- Keywords
- randomized controlled crossover trial, Randomized clinical trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Deeptankar DeMazumderUS federal agency
- Collaborators
- Relaxera Pharmaceuticals, McGowan Institute for Regenerative Medicine, University of Pittsburgh, Relaxera Pharmazeutische Gesellschaft mbH & Co. KG
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is the most common heart rhythm disorder. The presence of AF increases the risk of death and is associated with a 5-6-fold increase in stroke incidence, due almost exclusively to thrombus formation in the heart. Current therapies for AF are limited. The evaluation of new, more effective treatments for preventing AF recurrence remains a critical unmet clinical need. AF is considered a progressive disease that increases in prevalence with age and can convert from "paroxysmal" to "persistent" to "permanent" AF in a single individual. This progression results, in part, from high oxidative stress and progressive adverse electrical changes in the heart. Compelling preclinical and clinical data indicate that Relaxin, a naturally occurring peptide hormone, may reverse the electrical remodeling. Thus, our overall objective is to investigate the effects of Relaxin in Veterans who have failed medical management for symptomatic AF and is referred to Cardiac Electrophysiology Laboratory for catheter ablation and pulmonary vein isolation. We will determine whether Relaxin therapy, in addition to the standard of care, counteracts the oxidative stress-related electrical derangement and reduces the post-ablation AF burden. A unique aspect of this proposal is that it is based in part on observations derived from the basic, translational and computational labs of the PI and co-investigators and from the observations by the PI while caring for patients with AF. As such, this proposal represents a true progression from the bench to the bedside. If successful, our findings may lead to the design of a new, more effective treatment for a major unmet public health problem in the United States as well as the world.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care (including ablation) + Placebo x 9mo, then crossover to Relaxin therapy x 3mo | Experimental | Drug: Relaxin, Drug: PlaceboPatients receiving the standard of care (which includes catheter ablation) will be treatment in a double blinded manner with (1) Placebo for the first 9 months; and then (2) Relaxin, instead of Placebo, for another 3 months. |
| Standard of care (including ablation) + Relaxin therapy x 9mo, then crossover to Placebo x 3mo | Experimental | Drug: Relaxin, Drug: PlaceboPatients receiving the standard of care (which includes catheter ablation) will be treatment in a double blinded manner with (1) Relaxin for the first 9 months; and then (2) Placebo, instead of Relaxin, for another 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Diagnosed with AF and scheduled for elective catheter ablation for AF
Key exclusion criteria (6 listed)
- Enrollment in another Greater than Minimal Risk Study
- Pregnant, nursing, or sexually active females not using birth control or having been surgically sterilized
- Females who plan to become pregnant during the trial period
- Patients diagnosed with "permanent" AF, complete heart block, or a reversible cause of AF (e.g., transient thyrotoxicosis)
- Patients that require antiarrhythmic medication to started or continued during and after the ablation procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxinsubcutaneous injections of Relaxin once daily | Drug | Standard of care (including ablation) + Placebo x 9mo, then crossover to Relaxin therapy x 3mo, Standard of care (including ablation) + Relaxin therapy x 9mo, then crossover to Placebo x 3mo |
| Placebosubcutaneous injections of Placebo once daily | Drug | Standard of care (including ablation) + Placebo x 9mo, then crossover to Relaxin therapy x 3mo, Standard of care (including ablation) + Relaxin therapy x 9mo, then crossover to Placebo x 3mo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 390 days
The Primary Safety Outcome includes the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Ratio of the average daily AF burden before and after treatment
Time frame: 390 days
The Primary Efficacy Outcome includes the distribution of the ratio of the average daily AF burden before and after treatment over time. The daily AF burden is defined as the daily AF duration multiplied by the number of AF events including atrial ectopy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Yes. Data will be shared as allowed by applicable VA, state, federal and IP rules and policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Project Manager contact
Deeptankar DeMazumder, MD, PhD principal investigator
(1) VA Pittsburgh Health System; (2) McGowan Institute for Regenerative Medicine.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Relaxin in people with Atrial Fibrillation (AF) and Arrhythmia, run by Deeptankar DeMazumder.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager ((412) 822-2222), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 390 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.