Trial · NCT02391337

Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF)

NCT02391337, Phase 4, Completed, University of Birmingham; results first posted 2021-06-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF). Trials, record NCT02391337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02391337

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF)
NCT number: NCT02391337
Status: Completed
Phases: Phase 4
Enrollment: 161 participants, actual
Lead sponsor: University of Birmingham
Conditions: Permanent Atrial Fibrillation
Interventions: Bisoprolol, Digoxin
First posted: 2015-03-18
Last updated: 2021-06-18
Results first posted: 2021-06-16

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Patient Reported Quality of Life (SF-36)	Primary outcome at 6 months timepoint.	Patient-reported outcomes as assessed by the SF-36 questionnaire physical component score. The physical component score ranges from 0-100 where higher value indicates better outcome.
Secondary	Left Ventricular Ejection Fraction	12 months	The above parameters will be measured using echocardiography and diastolic indices
Secondary	Diastolic Function- Measured by the E/e'.	12 months	The above parameters will be measured using echocardiography and diastolic indices. E/e' - the ratio between early mitral inflow velocity and mitral annular early diastolic velocity.
Secondary	B-type Natriuretic Peptide (BNP) at 6 Months.	6 months	B-type natriuretic peptide (BNP) at 6 months.
Secondary	Composite Functional Status Measures- 6 Minute Walking Distance at 12 Months.	12 months	Composite functional status measures- 6 minute walking distance at 12 months.
Secondary	Patient Reported Outcomes- (AFEQT) at 12 Months.	12 months	As assessed using the AFEQT overall score at 12 months. The range for AFEQT overall score is from 0= complete disability to 100=no disability.
Secondary	Patient Reported Outcomes (SF36) Version 2 at 12 Months.	12 months	As assessed using the SF-36 version 2 global and specific scores at 12 months. All domains presented are between 0 to 100 scale where the higher score indicates better outcomes.
Secondary	Patient Reported Outcomes (EQ-5D-5L)	12 months	As assessed using the EQ-5D-5L summary index questionnaires at both 6 and 12 months. The range for summary index is from -0.594=worst score to 1=best score
Secondary	Ambulatory Heart-rate.	Within 12 months	24 hour ambulatory heart-rate.
Other	Cardiovascular Events	12 months	Number of Participants with hospital admissions for cardiovascular events.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Patient Reported Quality of Life (SF-36)	Primary outcome at 6 months timepoint.	ITT Analysis	score on a scale	MEAN
SECONDARY	Left Ventricular Ejection Fraction	12 months		percentage of ejection fraction	MEAN
SECONDARY	Diastolic Function- Measured by the E/e'.	12 months		Ratio of E/e'	MEAN
SECONDARY	B-type Natriuretic Peptide (BNP) at 6 Months.	6 months		ng/L	MEDIAN
SECONDARY	Composite Functional Status Measures- 6 Minute Walking Distance at 12 Months.	12 months		metres	MEDIAN
SECONDARY	Patient Reported Outcomes- (AFEQT) at 12 Months.	12 months		score on a scale	MEAN
SECONDARY	Patient Reported Outcomes (SF36) Version 2 at 12 Months.	12 months	Some domains of the SFF36 version 2 were not possible to be computed due to missing data in the questionnaire.	score on a scale	MEAN
SECONDARY	Patient Reported Outcomes (EQ-5D-5L)	12 months		units on a scale	MEAN
SECONDARY	Ambulatory Heart-rate.	Within 12 months		bpm	MEAN
OTHER_PRE_SPECIFIED	Cardiovascular Events	12 months		Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group62

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Patient Reported Quality of Life (SF-36)	Beta-blocker	29.7	Standard Deviation 11.4	score on a scale
Patient Reported Quality of Life (SF-36)	Digoxin	31.9	Standard Deviation 11.7	score on a scale
Left Ventricular Ejection Fraction	Beta-blocker	59.8	Standard Deviation 7.3	percentage of ejection fraction
Left Ventricular Ejection Fraction	Digoxin	59.7	Standard Deviation 8.7	percentage of ejection fraction
Diastolic Function- Measured by the E/e'.	Beta-blocker	10.8	Standard Deviation 5.5	Ratio of E/e'
Diastolic Function- Measured by the E/e'.	Digoxin	10.8	Standard Deviation 5.1	Ratio of E/e'
B-type Natriuretic Peptide (BNP) at 6 Months.	Beta-blocker	1209	Inter-Quartile Range 837 to 1531	ng/L
B-type Natriuretic Peptide (BNP) at 6 Months.	Digoxin	1057.5	Inter-Quartile Range 625.5 to 1531	ng/L
Composite Functional Status Measures- 6 Minute Walking Distance at 12 Months.	Beta-blocker	329	Inter-Quartile Range 120 to 429	metres
Composite Functional Status Measures- 6 Minute Walking Distance at 12 Months.	Digoxin	366	Inter-Quartile Range 233 to 435	metres

1 to 10 of 62Source ClinicalTrials.gov

See all 62 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Baseline	STARTED	Beta-blocker	80
Baseline	STARTED	Digoxin	81
Baseline	COMPLETED	Beta-blocker	80
Baseline	COMPLETED	Digoxin	81
Baseline	NOT COMPLETED	Beta-blocker	0
Baseline	NOT COMPLETED	Digoxin	0
6 Months Follow-up	STARTED	Beta-blocker	80
6 Months Follow-up	STARTED	Digoxin	81
6 Months Follow-up	COMPLETED	Beta-blocker	74
6 Months Follow-up	COMPLETED	Digoxin	76

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events64

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Gastrointestinal upset	Gastrointestinal disorders	Beta-blocker	8	80	8
other	Gastrointestinal upset	Gastrointestinal disorders	Digoxin	5	81	5
other	Blurred vision	Eye disorders	Beta-blocker	1	80	1
other	Blurred vision	Eye disorders	Digoxin	2	81	2
other	Rash	Skin and subcutaneous tissue disorders	Beta-blocker	0	80	0
other	Rash	Skin and subcutaneous tissue disorders	Digoxin	1	81	1
other	Peripheral oedema	General disorders	Beta-blocker	11	80	12
other	Peripheral oedema	General disorders	Digoxin	1	81	1
other	Symptomatic bradycardia	Cardiac disorders	Beta-blocker	5	80	5
other	Symptomatic bradycardia	Cardiac disorders	Digoxin	0	81	0

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Beta-blocker	7	80
Total, all-cause mortality	Digoxin	4	81
Total, other adverse events	Beta-blocker	51	80
Total, other adverse events	Digoxin	20	81
Total, serious adverse events	Beta-blocker	21	80
Total, serious adverse events	Digoxin	13	81

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25193873	BACKGROUND	PubMed
28729311	DERIVED	PubMed
33351042	DERIVED	PubMed
39009776	DERIVED	PubMed
39819610	DERIVED	PubMed
41462450	DERIVED	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 comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Beta-blocker vs Digoxin: Number of Participants With Unplanned Hospital Admissions.	Trial comparisons
Beta-blocker vs Digoxin: Drug Discontinuation Rate Within 12 Months.	Trial comparisons
Beta-blocker vs Digoxin: Hospital Admission Rate	Trial comparisons
Beta-blocker vs Digoxin: Cardiovascular Events	Trial comparisons
Beta-blocker vs Digoxin: deaths from any cause	Trial comparisons
Beta-blocker vs Digoxin: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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

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The record and each of its lists are JSON, twenty rows a page. No key.

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