Atrial FibrillationPhase 4IMPRESS-AFNCT02673463
Spironolactone in Atrial Fibrillation
A Phase 4 study testing Spironolactone in people with Atrial Fibrillation, run by University of Birmingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Spironolactone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham Institute of Cardiovascular Sciences
Birmingham, West Midlands, B18 7QH
About this study
Official title: Improved Exercise Tolerance in Participants With PReserved Ejection Fraction by Spironolactone on Myocardial Fibrosis in Atrial Fibrillation
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Spironolactone, Placebo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
Also called Aldactone
25 mg once daily
PlaceboDrug
Visually identical to spironolactone, once daily
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone | Experimental | Spironolactone 25 mg once daily for 2 years Receives: Drug: Spironolactone |
| Placebo | Placebo comparator | Matched placebo once daily for 2 years Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance (cardiopulmonary exercise testing)
Improvement in exercise tolerance (assessed using peak oxygen consumption on cardiopulmonary exercise testing)
Measured: 2 years of treatment
Secondary outcomes (6)
Quality of life (MLWHF)
Improvement in quality of life assessed using MLWHF questionnaire
Measured: 2 years of treatment
Quality of life (EQ-5D)
Improvement in quality of life assessed using EQ-5D questionnaire
Measured: 2 years of treatment
Left ventricular diastolic function
Improvement in diastolic function assessed using echocardiography (E/e' ratio)
Measured: 2 years of treatment
Exercise tolerance (6-minute walk test)
Improvement in exercise tolerance (assessed using 6-minute walk test)
Measured: 2 years of treatment
Rates of all-cause hospitalisations
Measured: 2 years of treatment
Spontaneous return to sinus rhythm on electrocardiogram
Measured: 2 years of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory YH Lip, MD, Principal investigator, University of BirminghamEduard Shantsila, PhD, Principal investigator, University of BirminghamPaulus Kirchhof, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673463
- Sponsor's protocol ID
- RG_14-150
- Acronym
- IMPRESS-AF
- Status last verified
- Oct 2018
- First submitted
- 1 Feb 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 32909497Shantsila 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.
PubMed 27707827
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Exercise Tolerance in Participants With PReserved Ejection Fraction by Spironolactone on Myocardial Fibrosis in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02673463
- Acronym / sponsor ID
- IMPRESS-AF / RG_14-150
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 4 Feb 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spironolactone | Experimental | Drug: SpironolactoneSpironolactone 25 mg once daily for 2 years |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo once daily for 2 years |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| SpironolactoneAlso: Aldactone25 mg once daily | Drug | Spironolactone |
| PlaceboVisually identical to spironolactone, once daily | Drug | Placebo |
Primary outcome
Exercise tolerance (cardiopulmonary exercise testing)
Time frame: 2 years of treatment
Improvement in exercise tolerance (assessed using peak oxygen consumption on cardiopulmonary exercise testing)
6 secondary outcomes
Quality of life (MLWHF)
Time frame: 2 years of treatment
Quality of life (EQ-5D)
Time frame: 2 years of treatment
Left ventricular diastolic function
Time frame: 2 years of treatment
Exercise tolerance (6-minute walk test)
Time frame: 2 years of treatment
Rates of all-cause hospitalisations
Time frame: 2 years of treatment
Spontaneous return to sinus rhythm on electrocardiogram
Time frame: 2 years of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 32909497Shantsila 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.
- Derived from this study: PubMed 27707827Shantsila 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Gregory YH Lip, MD principal investigator
University of Birmingham
Eduard Shantsila, PhD principal investigator
University of Birmingham
Paulus Kirchhof, PhD principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spironolactone in people with Atrial Fibrillation, run by University of Birmingham at 1 site in United Kingdom.
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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise tolerance (cardiopulmonary exercise testing) (time frame: 2 years of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02673463, which also lists 2 linked publications.
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 11 Oct 2018; AzTrials last refreshed its copy on 1 Nov 2026.