Trial · NCT03718273
IvaBRAdine blocK of Funny Current for Heart Rate Control in permanEnt Atrial Fibrillation. (BRAKE-AF Study).
NCT03718273, Phase 3, Completed, Adolfo Fontenla
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IvaBRAdine blocK of Funny Current for Heart Rate Control in permanEnt Atrial Fibrillation. (BRAKE-AF Study). Trials, record NCT03718273. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03718273
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IvaBRAdine blocK of Funny Current for Heart Rate Control in permanEnt Atrial Fibrillation. (BRAKE-AF Study).
- NCT number
- NCT03718273
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 68 participants, actual
- Lead sponsor
- Adolfo Fontenla
- Conditions
- Atrial Fibrillation, Heart Diseases
- Interventions
- Ivabradine, Digoxin
- First posted
- 2018-10-24
- Last updated
- 2022-10-07
- Other registries' IDs
- eudract:2018-001936-23
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Heart rate reduction. | 3 months | Reduction of the mean daytime heart rate registered in Holter- electrocardiogram (ECG) after treatment with Ivabradine or Digoxin. |
| Primary | Serious adverse events | 3 months | Proportion of patients experiencing syncope, severe bradycardia or any serious adverse reaction requiring hospitalization, emergency visit or death of the patient during treatment with Ivabradine or Digoxin. |
| Secondary | Reduction in the scale of atrial fibrillation (AF) symptoms according to the European Hearth Rhythm Association (EHRA) Score modified. | Months 1 and 3. | Percentage of patients who experience a reduction in the scale of atrial fibrillation. symptoms according to the EHRA Score modified. |
| Secondary | 6 minute walk test (6MWT). | Baseline and after 3 months. | Increase in meters in the 6MWT. |
| Secondary | Quality-of-Life Short Form 36 (SF-36) Health Survey (QoL SF-36) Score. | At baseline and 3 months. | Increase in the score obtained in global quality of life parameters analyzed by the SF-36 questionnaire. |
| Secondary | The Atrial Fibrillation Effect on Quality-of-Life (QoL AFEQT) score. | At baseline and 3 months | Increase in the score obtained in parameters of quality of life quality of life associated with AF analyzed by the AFEQT questionnaire. |
| Secondary | Reduction of the daytime Health rate. | 1 month | Reduction of the average daytime Heart Rate (HR) recorded in Holter-ECG |
| Secondary | Reduction of resting Health Rate. | 1 and 3 months | Reduction of resting heart rate (HR) recorded on one electrocardiogram (ECG). |
| Secondary | Reduction of the maximum heart rate (HR) recorded. | 1 and 3 months | Reduction of the maximum HR recorded in Holter-ECG |
| Secondary | Reduction of the mean HR recorded. | 1 and 3 months | Reduction of the mean HR in 24 hours recorded in Holter-ECG . |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31631048 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03718273
GET https://conductscience.org/api/trials/v1/NCT03718273/registered