Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spironolactone in Atrial Fibrillation (IMPRESS-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673463
Recruitment Status : Unknown
Verified October 2018 by University of Birmingham.
Recruitment status was:  Active, not recruiting
First Posted : February 4, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Birmingham

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Spironolactone Drug: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improved Exercise Tolerance in Participants With PReserved Ejection Fraction by Spironolactone on Myocardial Fibrosis in Atrial Fibrillation
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spironolactone
Spironolactone 25 mg once daily for 2 years
Drug: Spironolactone
25 mg once daily
Other Name: Aldactone

Placebo Comparator: Placebo
Matched placebo once daily for 2 years
Drug: Placebo
Visually identical to spironolactone, once daily




Primary Outcome Measures :
  1. Exercise tolerance (cardiopulmonary exercise testing) [ Time Frame: 2 years of treatment ]
    Improvement in exercise tolerance (assessed using peak oxygen consumption on cardiopulmonary exercise testing)


Secondary Outcome Measures :
  1. Quality of life (MLWHF) [ Time Frame: 2 years of treatment ]
    Improvement in quality of life assessed using MLWHF questionnaire

  2. Quality of life (EQ-5D) [ Time Frame: 2 years of treatment ]
    Improvement in quality of life assessed using EQ-5D questionnaire

  3. Left ventricular diastolic function [ Time Frame: 2 years of treatment ]
    Improvement in diastolic function assessed using echocardiography (E/e' ratio)

  4. Exercise tolerance (6-minute walk test) [ Time Frame: 2 years of treatment ]
    Improvement in exercise tolerance (assessed using 6-minute walk test)

  5. Rates of all-cause hospitalisations [ Time Frame: 2 years of treatment ]
  6. Spontaneous return to sinus rhythm on electrocardiogram [ Time Frame: 2 years of treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673463


Locations
Layout table for location information
United Kingdom
University of Birmingham Institute of Cardiovascular Sciences
Birmingham, West Midlands, United Kingdom, B18 7QH
Sponsors and Collaborators
University of Birmingham
Investigators
Layout table for investigator information
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT02673463    
Other Study ID Numbers: RG_14-150
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents