NCT02673463

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jan 2015

Typical duration for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

3.9 years

First QC Date

February 1, 2016

Last Update Submit

October 10, 2018

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Exercise tolerance (cardiopulmonary exercise testing)

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

    2 years of treatment

Secondary Outcomes (6)

  • Quality of life (MLWHF)

    2 years of treatment

  • Quality of life (EQ-5D)

    2 years of treatment

  • Left ventricular diastolic function

    2 years of treatment

  • Exercise tolerance (6-minute walk test)

    2 years of treatment

  • Rates of all-cause hospitalisations

    2 years of treatment

  • +1 more secondary outcomes

Study Arms (2)

Spironolactone

EXPERIMENTAL

Spironolactone 25 mg once daily for 2 years

Drug: Spironolactone

Placebo

PLACEBO COMPARATOR

Matched placebo once daily for 2 years

Drug: Placebo

Interventions

SpironolactoneDRUG

25 mg once daily

Also known as: Aldactone
Spironolactone
PlaceboDRUG

Visually identical to spironolactone, once daily

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Birmingham Institute of Cardiovascular Sciences

Birmingham, West Midlands, B18 7QH, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 32909497DERIVED

  • 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.

    PMID: 27707827DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Gregory YH Lip, MD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

  • Eduard Shantsila, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

  • Paulus Kirchhof, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 4, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

GB(1)