Atrial Fibrillation RecurrentPhase 3SPONSoRNCT06204640
SPironolactONe for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation
A Phase 3 study testing Spironolactone in people with Atrial Fibrillation Recurrent, run by University Hospital, Caen.
Trial summary
Introduction: There is evidence that aldosterone and the activation of its receptor, mineralocorticoid receptor (MR), promote cardiac fibrosis and electrical disturbances. clinical data suggest that MRAs could have positive effects on AF burden, but some inconsistent results have been reported. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Recurrent
- What is being tested?
- Spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Jan 2029
- Phase
- Phase 3
- 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
- Male or female (since spironolactone is not recommended during pregnancy and breastfeeding, a highly sensitive pregnancy test (serum HCG) will be systematically carried out in women of childbearing age and information will be given to non-pregnant women at the time of inclusion to instruct them to use an effective method of contraception during all the study period. Effective methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal, or progestogen-only hormonal contraception associated with inhibition of ovulation : oral, injectable, implantable, or intrauterine device, or intrauterine hormone-releasing system, or bilateral tubal occlusion or vasectomised partner, or sexual abstinence)
- Age > 18 years
- Hypertension defined as current use of anti-hypertensive drugs for more than 12 months
- Paroxysmal or no long-standing persistent AF (as defined by the ESC guidelines) with at least 1 episode within the preceding 6 months
- Sinus rhythm at enrolment
- Patient signed consent
Show all 9Show fewer
- Willing to comply with scheduled visits, as outlined in the protocol
- French speaking
- Recipients of the social security regime
Who cannot join
- Contraindications to spironolactone therapy: pregnancy, breastfeeding, intolerance, hyperkalemia (>5.0 mmol/L), severe renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1,73m² (per the CKD-EPI equation). Subjects with serum creatinine ≥2.5 mg/dl are also excluded even if their eGFR is ≥30 ml/min/1,73m²), Severe liver dysfunction.
- Patients already treated by other potassium sparing medication (amiloride, triamterene) or MRA (spironolactone, eplerenone, potassium canreonate, finerenone).
- Other MRAs indication: aldosteronism, heart failure, cirrhosis ascites, nephrotic syndrome, myasthenia
- LVEF < 40% obtained within 6 months prior to V0
- Planned atrial fibrillation ablation within 6 months after randomization
- Moderate-to-severe valvular heart disease
Show all 19Show fewer
- Permanent AF or long-standing persistent AF as defined by the ESC guidelines
- AF on the ECG at the inclusion visit
- Previous left atrial ablation or previous maze or maze-like surgery
- Acute, reversible or secondary AF (infection, hyperthyroidism, pericarditis or myocarditis)
- Left atrium diameter > 60 mm obtained within 6 months prior to V0
- Contraindication to oral anticoagulation therapy
- Patients with persistent bradycardia of less than 50 beats per minute, a PR interval of 0.2 second or more on ECG, second degree (or higher) atrioventricular block, and snus-node disease without an implanted pacemaker
- Hemodynamic instability and unstable conditions: angina or acute coronary syndrome or heart failure during the last 3 months, cardiogenic shock
- A life expectancy of 1 years or less
- Patients included or planning to be included in another medical research protocol whose pharmacological and scientific rationales might interfere with the Sponsor trial
- Patients unable to complete the protocol follow-up
- Pregnant or nursing women
- Adults with protective measures (curatorship or tutorship) and vulnerable patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: SPironolactONe for the Maintenance of Sinus Rhythm in Hypertensive Patients With Atrial Fibrillation and Preserved Left Ventricular Ejection Fraction (SPONSoR Study).
Introduction:
There is evidence that aldosterone and the activation of its receptor, mineralocorticoid receptor (MR), promote cardiac fibrosis and electrical disturbances. clinical data suggest that MRAs could have positive effects on AF burden, but some inconsistent results have been reported.
Read more
Therefore, investigators propose to perform a randomized, multicenter, open blinded end-point (PROBE) study to evaluate the efficacy of spironolactone on AF recurrence in hypertensive patients with preserved LVEF.
Materials and methods:
SPONSoR trial will be a multicenter, landmark, randomized, open blinded end-point (PROBE) trial of the MRA, spironolactone, in 580 hypertensive patients referred for AF with preserved LVEF.
580 patients will be randomized in a 1:1 ratio to either receive oral spironolactone once daily on top of standard therapy or standard therapy alone, started the day of randomization and continued for 12 months. Spironolactone will be start at 25 mg per day initially then titrated to a maximum of 50 mg per day in the absence of contraindication at the 1-month study visit. AF detection will be provided by the use of a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings) throughout the duration of the study. These wearables optical PPG devices (ScanWatch 42mm®, Withings).
The trial duration is 3 years (24 months for inclusion with 12 months of follow-up; total duration participation for the patient of 12 months).
Read the detailed description
Introduction:
There is evidence that aldosterone and the activation of its receptor, mineralocorticoid receptor (MR), promote cardiac fibrosis and electrical disturbances. clinical data suggest that MRAs could have positive effects on AF burden, but some inconsistent results have been reported.
Investigators recently published a systematic review and meta-analysis of both randomized clinical trials (RCTs) and observational studies to examine the effect of MRA use on AF occurrence. Investigators also performed subgroup and meta-regression analyses to explore the source of heterogeneity and identify modifying factors. In this meta-analysis, investigators included 24 studies with a cumulative number of 7,914 patients (median age: 64.2 years, median left ventricular ejection fraction: 49.7%, median follow-up: 12.0 months), with 2,843 (35.9%) of whom received a MRA therapy. Meta-analyses showed a significant overall reduction in AF occurrence in the MRA-treated patients vs the control-groups (15.0% versus 32.2%; OR: 0.55, 95% CI: 0.44-0.70; p<0.00001), with the greatest benefit regarding recurrent AF episodes (OR: 0.42, 95% CI: 0.31-0.59; p<0.00001). The MRAs benefit of MRA therapy was consistent in both HF and non-HF patients. Meta-regression analyses showed that results of the studies were significantly associated with higher AF occurrence rate in the control-groups.
Therefore, investigators propose to perform a randomized, multicenter, open blinded end-point (PROBE) study to evaluate the efficacy of spironolactone on AF recurrence in hypertensive patients with preserved LVEF.
Materials and methods:
SPONSoR trial will be a multicenter, landmark, randomized, open blinded end-point (PROBE) trial of the MRA, spironolactone, in 580 hypertensive patients referred for AF with preserved LVEF.
After assessment of inclusion and non-inclusion criteria and following collection of the patient's written consent, 580 patients will be randomized in a 1:1 ratio to either receive oral spironolactone once daily on top of standard therapy or standard therapy alone, started the day of randomization and continued for 12 months. Spironolactone will be start at 25 mg per day initially then titrated to a maximum of 50 mg per day in the absence of contraindication at the 1-month study visit. All subjects are to be treated using the most adapted therapy based on international guidelines, including antiarrhythmic drugs and betablockers. Investigators and patients will be aware of study group allocation. The randomization will be stratified on centers for administrative reason and to allow center-withdrawal and on age (<70 years old and ≥ 70 years old). All randomized subjects will be followed even if study drug is discontinued ahead of schedule, except in the case that the subject refuses to participate further in the study.
After randomization, patients will be follow-up with study visits at months 1, 6, and 12, including systematic 12-leads ECG and serum electrolytes measurements. AF detection will be provided by the use of a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings) throughout the duration of the study. These wearables optical PPG devices (ScanWatch 38mm®, Withings) allow us to detect effectively AF without side effects encountered with other technologies (cables, cutaneous reactions to patches, subcutaneous implantation ...). This continuous pulse monitoring will allow us to be optimal in AF detection. Blood samples will be collected at baseline to measure aldosterone level and then will be stored in the Caen University CRB for later use in ancillary studies.
The trial duration is 3 years (24 months for inclusion with 12 months of follow-up; total duration participation for the patient of 12 months). Patients will begin the treatment (spironolactone on top of standard therapy or standard therapy alone) at V0 and continue until V3.
- Conditions
- Atrial Fibrillation Recurrent
- Being tested
- Spironolactone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
Spironolactone will be start at 25 mg per day initially then titrated to a maximum of 50 mg per day in the absence of contraindication at the 1-month study visit.
| Study group | Role | What they receive |
|---|---|---|
| spironolactone | Experimental | Not described Receives: Drug: Spironolactone |
| standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrence
First documented recurrence of AF occurring from randomization and within 12 months, defined as an episode lasting for at least 30 sec documented on 12-leads ECG (planned or not) or on a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings).
Measured: from randomization and within12 months
Secondary outcomes (8)
symptomatic AF recurrence
The recurrence of symptomatic documented AF episodes from randomization and within 12 months,
Measured: from randomization and within12 months
delay of AF recurrence
The delay (days) of recurrence of the first documented AF episode (symptomatic or not) during the follow-up,
Measured: from randomization and within12 months
AF burden
The cumulative burden of AF defined as the percentage of time in irregular rhtyhm on the wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings),
Measured: from randomization and within12 months
MACE
Composite of major cardiovascular events and death (death from any cause, stroke, heart failure, myocardial infarction) occurring from randomization and within 12 months,
Measured: from randomization and within12 months
cerebral/systemic thrombo-embolic and bleeding event
Occurrence of cerebral/systemic thrombo-embolic and bleeding event
Measured: from randomization and within12 months
AF heart rate
Mean ventricular rate (beats per minute) at the recurrence of AF on 12-leads ECG (planned or not) or on a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings),
Measured: from randomization and within12 months
blood pressure
Blood pressure-lowering efficacy evaluated on blood pressure measurements (both systolic and diastolic) from randomization to 1, 6, and 12 months as assessed by office blood pressure
Measured: from randomization and within12 months
safety of spironolactone
Occurrence of any adverse event supposed to be associated with spirolonactone exposure from randomization and within 12 months.
Measured: from randomization and within12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation RecurrentStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204640
- Sponsor's protocol ID
- SPONSoR
- Acronym
- SPONSoR
- Status last verified
- Jul 2023
- First submitted
- 13 Sep 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available for sharement upon reasonable demand and after publication of the SPONSOR study
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPironolactONe for the Maintenance of Sinus Rhythm in Hypertensive Patients With Atrial Fibrillation and Preserved Left Ventricular Ejection Fraction (SPONSoR Study).
- ClinicalTrials.gov ID
- NCT06204640
- Acronym / sponsor ID
- SPONSoR / SPONSoR
- Conditions
- Atrial Fibrillation Recurrent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 12 Jan 2024 (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.
Introduction:
There is evidence that aldosterone and the activation of its receptor, mineralocorticoid receptor (MR), promote cardiac fibrosis and electrical disturbances. clinical data suggest that MRAs could have positive effects on AF burden, but some inconsistent results have been reported.
Therefore, investigators propose to perform a randomized, multicenter, open blinded end-point (PROBE) study to evaluate the efficacy of spironolactone on AF recurrence in hypertensive patients with preserved LVEF.
Materials and methods:
SPONSoR trial will be a multicenter, landmark, randomized, open blinded end-point (PROBE) trial of the MRA, spironolactone, in 580 hypertensive patients referred for AF with preserved LVEF.
580 patients will be randomized in a 1:1 ratio to either receive oral spironolactone once daily on top of standard therapy or standard therapy alone, started the day of randomization and continued for 12 months. Spironolactone will be start at 25 mg per day initially then titrated to a maximum of 50 mg per day in the absence of contraindication at the 1-month study visit. AF detection will be provided by the use of a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings) throughout the duration of the study. These wearables optical PPG devices (ScanWatch 42mm®, Withings).
The trial duration is 3 years (24 months for inclusion with 12 months of follow-up; total duration participation for the patient of 12 months).
Detailed description
Introduction:
There is evidence that aldosterone and the activation of its receptor, mineralocorticoid receptor (MR), promote cardiac fibrosis and electrical disturbances. clinical data suggest that MRAs could have positive effects on AF burden, but some inconsistent results have been reported.
Investigators recently published a systematic review and meta-analysis of both randomized clinical trials (RCTs) and observational studies to examine the effect of MRA use on AF occurrence. Investigators also performed subgroup and meta-regression analyses to explore the source of heterogeneity and identify modifying factors. In this meta-analysis, investigators included 24 studies with a cumulative number of 7,914 patients (median age: 64.2 years, median left ventricular ejection fraction: 49.7%, median follow-up: 12.0 months), with 2,843 (35.9%) of whom received a MRA therapy. Meta-analyses showed a significant overall reduction in AF occurrence in the MRA-treated patients vs the control-groups (15.0% versus 32.2%; OR: 0.55, 95% CI: 0.44-0.70; p<0.00001), with the greatest benefit regarding recurrent AF episodes (OR: 0.42, 95% CI: 0.31-0.59; p<0.00001). The MRAs benefit of MRA therapy was consistent in both HF and non-HF patients. Meta-regression analyses showed that results of the studies were significantly associated with higher AF occurrence rate in the control-groups.
Therefore, investigators propose to perform a randomized, multicenter, open blinded end-point (PROBE) study to evaluate the efficacy of spironolactone on AF recurrence in hypertensive patients with preserved LVEF.
Materials and methods:
SPONSoR trial will be a multicenter, landmark, randomized, open blinded end-point (PROBE) trial of the MRA, spironolactone, in 580 hypertensive patients referred for AF with preserved LVEF.
After assessment of inclusion and non-inclusion criteria and following collection of the patient's written consent, 580 patients will be randomized in a 1:1 ratio to either receive oral spironolactone once daily on top of standard therapy or standard therapy alone, started the day of randomization and continued for 12 months. Spironolactone will be start at 25 mg per day initially then titrated to a maximum of 50 mg per day in the absence of contraindication at the 1-month study visit. All subjects are to be treated using the most adapted therapy based on international guidelines, including antiarrhythmic drugs and betablockers. Investigators and patients will be aware of study group allocation. The randomization will be stratified on centers for administrative reason and to allow center-withdrawal and on age (<70 years old and ≥ 70 years old). All randomized subjects will be followed even if study drug is discontinued ahead of schedule, except in the case that the subject refuses to participate further in the study.
After randomization, patients will be follow-up with study visits at months 1, 6, and 12, including systematic 12-leads ECG and serum electrolytes measurements. AF detection will be provided by the use of a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings) throughout the duration of the study. These wearables optical PPG devices (ScanWatch 38mm®, Withings) allow us to detect effectively AF without side effects encountered with other technologies (cables, cutaneous reactions to patches, subcutaneous implantation ...). This continuous pulse monitoring will allow us to be optimal in AF detection. Blood samples will be collected at baseline to measure aldosterone level and then will be stored in the Caen University CRB for later use in ancillary studies.
The trial duration is 3 years (24 months for inclusion with 12 months of follow-up; total duration participation for the patient of 12 months). Patients will begin the treatment (spironolactone on top of standard therapy or standard therapy alone) at V0 and continue until V3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spironolactone | Experimental | Drug: Spironolactone |
| standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female (since spironolactone is not recommended during pregnancy and breastfeeding, a highly sensitive pregnancy test (serum HCG) will be systematically carried out in women of childbearing age and information will be given to non-pregnant women at the time of inclusion to instruct them to use an effective method of contraception during all the study period. Effective methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal, or progestogen-only hormonal contraception associated with inhibition of ovulation : oral, injectable, implantable, or intrauterine device, or intrauterine hormone-releasing system, or bilateral tubal occlusion or vasectomised partner, or sexual abstinence)
- Age > 18 years
- Hypertension defined as current use of anti-hypertensive drugs for more than 12 months
- Paroxysmal or no long-standing persistent AF (as defined by the ESC guidelines) with at least 1 episode within the preceding 6 months
- Sinus rhythm at enrolment
Key exclusion criteria (19 listed)
- Contraindications to spironolactone therapy: pregnancy, breastfeeding, intolerance, hyperkalemia (>5.0 mmol/L), severe renal dysfunction (defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1,73m² (per the CKD-EPI equation). Subjects with serum creatinine ≥2.5 mg/dl are also excluded even if their eGFR is ≥30 ml/min/1,73m²), Severe liver dysfunction.
- Patients already treated by other potassium sparing medication (amiloride, triamterene) or MRA (spironolactone, eplerenone, potassium canreonate, finerenone).
- Other MRAs indication: aldosteronism, heart failure, cirrhosis ascites, nephrotic syndrome, myasthenia
- LVEF < 40% obtained within 6 months prior to V0
- Planned atrial fibrillation ablation within 6 months after randomization
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 |
|---|---|---|
| SpironolactoneSpironolactone will be start at 25 mg per day initially then titrated to a maximum of 50 mg per day in the absence of contraindication at the 1-month study visit. | Drug | spironolactone |
Primary outcome
AF recurrence
Time frame: from randomization and within12 months
First documented recurrence of AF occurring from randomization and within 12 months, defined as an episode lasting for at least 30 sec documented on 12-leads ECG (planned or not) or on a wearable optical photoplethysmography (PPG) device (ScanWatch 42mm®, Withings).
8 secondary outcomes
symptomatic AF recurrence
Time frame: from randomization and within12 months
delay of AF recurrence
Time frame: from randomization and within12 months
AF burden
Time frame: from randomization and within12 months
MACE
Time frame: from randomization and within12 months
cerebral/systemic thrombo-embolic and bleeding event
Time frame: from randomization and within12 months
AF heart rate
Time frame: from randomization and within12 months
blood pressure
Time frame: from randomization and within12 months
safety of spironolactone
Time frame: from randomization and within12 months
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 12 Jan 2024.
- Individual participant dataSharing planned: Yes. IPD will be available for sharement upon reasonable demand and after publication of the SPONSOR study
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spironolactone in people with Atrial Fibrillation Recurrent, run by University Hospital, Caen.
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 9 inclusion and 19 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 12 Jan 2024. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Joachim Alexandre, MD, PhD (+330231063106, alexandre-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF recurrence (time frame: from randomization and within12 months). 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 12 Jan 2024.