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NCT03929718
A Randomized Prospective Pilot Study to Evaluate Efficacy of Aldosterone Antagonist Therapy for Prevention of New Atrial Fibrillation (AF) in Patients With Atrial Flutter (AFL), But no Previously Detected AF, Undergoing caVOtricuspID Isthmus Ablation
EARLY_PHASE1 trial testing Spironolactone in AFib in 50 participants. Participants enrolled and being followed up; not accepting new ones.
1 September 2025
Quick facts
| Lead sponsor | Piedmont Healthcare |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 24 April 2019 |
| Primary completion | 1 September 2025 |
| Estimated completion | 1 September 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Spironolactone (spironolactone) — full drug profile →
- No Spironolactone — full drug profile →
Conditions studied
- AFib — all drugs for AFib →
Sponsor
Piedmont Healthcare — full company profile →
Who can join
18 and older, any sex, with AFib. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Long-Term incidence of new-onset AF after CTI ablation
Time frame: 24 months
1\. To accurately determine the long-term incidence of new-onset AF after CTI ablation using an implantable rhythm monitor -
Rates of new-onset AF between standard therapy and spironolactone
Time frame: 24 months
2\. To compare the rates of new onset AF in subjects randomized to standard medical therapy following CTI ablation compared with those randomized to treatment with an aldosterone antagonist (spironolactone)
Sponsor's own description
The purpose of this study is to accurately determine, using an implantable rhythm monitor, the long-term incidence of new atrial fibrillation after ablation of atrial flutter in those treated with spironolactone compared with standard medical therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03929718
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Spironolactone
Trials testing the same drug.
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- NCT06204640 — SPironolactONe for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation · Phase 3 · not yet recruiting
- NCT06164379 — Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism · Phase 4 · unknown
- NCT06004830 — Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1 · Phase 2 · active not recruiting
- NCT06641284 — Gender-Based Differences in Heart Failure Hospitalizations Among Patients With Heart Failure Treated With Spironolactone · completed
Other Piedmont Healthcare trials
Trials by the same sponsor.
- NCT05238220 — Utilization of the Viracor® Assay for Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients · completed
- NCT03389971 — ULTRAsound-assisted Catheter vs. STAndaRd Catheter Thrombolysis for Submassive Pulmonary Embolism · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03929718 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Piedmont Healthcare
- Last refreshed: 27 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03929718.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing