Spironolactone in Atrial Fibrillation (IMPRESS-AF)

October 10, 2018 updated by: University of Birmingham

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B18 7QH
        • University of Birmingham Institute of Cardiovascular Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spironolactone
Spironolactone 25 mg once daily for 2 years
Drug: Spironolactone
25 mg once daily
Other Names:
  • Aldactone
Placebo Comparator: Placebo
Matched placebo once daily for 2 years
Drug: Placebo
Visually identical to spironolactone, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise tolerance (cardiopulmonary exercise testing)
Time Frame: 2 years of treatment
Improvement in exercise tolerance (assessed using peak oxygen consumption on cardiopulmonary exercise testing)
2 years of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (MLWHF)
Time Frame: 2 years of treatment
Improvement in quality of life assessed using MLWHF questionnaire
2 years of treatment
Quality of life (EQ-5D)
Time Frame: 2 years of treatment
Improvement in quality of life assessed using EQ-5D questionnaire
2 years of treatment
Left ventricular diastolic function
Time Frame: 2 years of treatment
Improvement in diastolic function assessed using echocardiography (E/e' ratio)
2 years of treatment
Exercise tolerance (6-minute walk test)
Time Frame: 2 years of treatment
Improvement in exercise tolerance (assessed using 6-minute walk test)
2 years of treatment
Rates of all-cause hospitalisations
Time Frame: 2 years of treatment
2 years of treatment
Spontaneous return to sinus rhythm on electrocardiogram
Time Frame: 2 years of treatment
2 years of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Investigators

  • Principal Investigator: Gregory YH Lip, MD, University of Birmingham
  • Principal Investigator: Eduard Shantsila, PhD, University of Birmingham
  • Principal Investigator: Paulus Kirchhof, PhD, University of Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG_14-150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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