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Spironolactone in Atrial Fibrillation (IMPRESS-AF)

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Spironolactone
Placebo
Sponsored by
University of Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Permanent AF
  • Left ventricular ejection fraction >= 55% as established by echocardiography
  • Able to perform cardio-pulmonary exercise testing using a cycling ergometer and complete quality of life questionnaires in English or in their native language.

Exclusion Criteria:

  • Severe systemic illness (life expectancy <2 years)
  • Severe chronic obstructive pulmonary disease (e.g., requiring home oxygen or chronic oral steroid therapy)
  • Severe mitral/aortal valve stenosis/regurgitation
  • Significant renal dysfunction (serum creatinine 220 µmol/L or above), anuria, active renal insufficiency, rapidly progressing or severe impairment of renal function, confirmed or suspected renal insufficiency in diabetic patients/ diabetic nephropathy
  • Increase in potassium level to >5mmol/L
  • Recent coronary artery bypass graft surgery (within 3 months)
  • Use of aldosterone antagonist within 14 days before randomisation
  • Use of or potassium sparing diuretic within 14 days before randomisation
  • Systolic blood pressure >160 mm Hg
  • Addison's disease
  • Hypersensitivity to spironolactone or any of the ingredients in the product
  • Any participant characteristic that may interfere with adherence to the trial protocol

Sites / Locations

  • University of Birmingham Institute of Cardiovascular Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Spironolactone

Placebo

Arm Description

Spironolactone 25 mg once daily for 2 years

Matched placebo once daily for 2 years

Outcomes

Primary Outcome Measures

Exercise tolerance (cardiopulmonary exercise testing)
Improvement in exercise tolerance (assessed using peak oxygen consumption on cardiopulmonary exercise testing)

Secondary Outcome Measures

Quality of life (MLWHF)
Improvement in quality of life assessed using MLWHF questionnaire
Quality of life (EQ-5D)
Improvement in quality of life assessed using EQ-5D questionnaire
Left ventricular diastolic function
Improvement in diastolic function assessed using echocardiography (E/e' ratio)
Exercise tolerance (6-minute walk test)
Improvement in exercise tolerance (assessed using 6-minute walk test)
Rates of all-cause hospitalisations
Spontaneous return to sinus rhythm on electrocardiogram

Full Information

First Posted
February 1, 2016
Last Updated
October 10, 2018
Sponsor
University of Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT02673463
Brief Title
Spironolactone in Atrial Fibrillation
Acronym
IMPRESS-AF
Official Title
Improved Exercise Tolerance in Participants With PReserved Ejection Fraction by Spironolactone on Myocardial Fibrosis in Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to assess whether treatment with a drug called spironolactone, which is an aldosterone inhibitor, can improve ability to cope with exertion, quality of life and ability of the heart to relax better in symptomatic patients with atrial fibrillation with preserved pumping capacity.
Detailed Description
IMPRESS-AF study is a double-blinded randomised placebo-controlled trial of 2-year treatment with an aldosterone antagonist, spironolactone (25mg once daily) vs placebo in 250 patients with symptomatic chronic atrial fibrillation and preserved left ventricular contractility (both added to the current optimised care). The trial will establish impact of spironolactone on the primary outcome of exercise tolerance (peak oxygen consumption on cardiopulmonary exercise testing) and secondary outcomes: (i) health-related quality of life (assessed using the validated Minnesota Living with Heart Failure and EuroQol EQ-5D questionnaires self-completed by patients), and (ii) left ventricular diastolic function (E/e' ratio on echocardiography) - all assessed at baseline and at 2 years; (iii) rates of all-cause hospitalisations during 2-year follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spironolactone
Arm Type
Experimental
Arm Description
Spironolactone 25 mg once daily for 2 years
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo once daily for 2 years
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Other Intervention Name(s)
Aldactone
Intervention Description
25 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Visually identical to spironolactone, once daily
Primary Outcome Measure Information:
Title
Exercise tolerance (cardiopulmonary exercise testing)
Description
Improvement in exercise tolerance (assessed using peak oxygen consumption on cardiopulmonary exercise testing)
Time Frame
2 years of treatment
Secondary Outcome Measure Information:
Title
Quality of life (MLWHF)
Description
Improvement in quality of life assessed using MLWHF questionnaire
Time Frame
2 years of treatment
Title
Quality of life (EQ-5D)
Description
Improvement in quality of life assessed using EQ-5D questionnaire
Time Frame
2 years of treatment
Title
Left ventricular diastolic function
Description
Improvement in diastolic function assessed using echocardiography (E/e' ratio)
Time Frame
2 years of treatment
Title
Exercise tolerance (6-minute walk test)
Description
Improvement in exercise tolerance (assessed using 6-minute walk test)
Time Frame
2 years of treatment
Title
Rates of all-cause hospitalisations
Time Frame
2 years of treatment
Title
Spontaneous return to sinus rhythm on electrocardiogram
Time Frame
2 years of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Permanent AF Left ventricular ejection fraction >= 55% as established by echocardiography Able to perform cardio-pulmonary exercise testing using a cycling ergometer and complete quality of life questionnaires in English or in their native language. Exclusion Criteria: Severe systemic illness (life expectancy <2 years) Severe chronic obstructive pulmonary disease (e.g., requiring home oxygen or chronic oral steroid therapy) Severe mitral/aortal valve stenosis/regurgitation Significant renal dysfunction (serum creatinine 220 µmol/L or above), anuria, active renal insufficiency, rapidly progressing or severe impairment of renal function, confirmed or suspected renal insufficiency in diabetic patients/ diabetic nephropathy Increase in potassium level to >5mmol/L Recent coronary artery bypass graft surgery (within 3 months) Use of aldosterone antagonist within 14 days before randomisation Use of or potassium sparing diuretic within 14 days before randomisation Systolic blood pressure >160 mm Hg Addison's disease Hypersensitivity to spironolactone or any of the ingredients in the product Any participant characteristic that may interfere with adherence to the trial protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory YH Lip, MD
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eduard Shantsila, PhD
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulus Kirchhof, PhD
Organizational Affiliation
University of Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Birmingham Institute of Cardiovascular Sciences
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B18 7QH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32909497
Citation
Shantsila E, Shahid F, Sun Y, Deeks J, Calvert M, Fisher JP, Kirchhof P, Gill PS, Lip GYH. Spironolactone in Atrial Fibrillation With Preserved Cardiac Fraction: The IMPRESS-AF Trial. J Am Heart Assoc. 2020 Sep 15;9(18):e016239. doi: 10.1161/JAHA.119.016239. Epub 2020 Sep 10.
Results Reference
derived
PubMed Identifier
27707827
Citation
Shantsila E, Haynes R, Calvert M, Fisher J, Kirchhof P, Gill PS, Lip GY. IMproved exercise tolerance in patients with PReserved Ejection fraction by Spironolactone on myocardial fibrosiS in Atrial Fibrillation rationale and design of the IMPRESS-AF randomised controlled trial. BMJ Open. 2016 Oct 5;6(10):e012241. doi: 10.1136/bmjopen-2016-012241.
Results Reference
derived

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Spironolactone in Atrial Fibrillation

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