Effects of Spironolactone in Heart Failure with Preserved Ejection Fraction: Measured by CMR, Echo, Excercise Capacity and Quality of Life Questionaire

Phase 1

• Conditions: Heart failure with a preserved ejection fraction; MedDRA version: 16.1 Level: LLT Classification code 10069211 Term: Diastolic heart failure System Organ Class: 10007541 - Cardiac disorders; MedDRA version: 16.1 Level: LLT Classification code 10028049 Term: MRI System Organ Class: 100000004848; MedDRA version: 16.1 Level: PT Classification code 10052337 Term: Diastolic dysfunction System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2013-000867-10-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-13
• Study Completion: 2017-07-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 51

Inclusion Criteria

Diagnosis of heart failure with preserved ejection fraction (HF-PEF)
NYHA II-IV heart failure
Compliance with medical treatment

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Contra-indication to undergoing full cardiac magnetic resonance study
Contra-indication to aldosterone antagonist therapy
Contra-indication to exercise testing
Unable to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To define mechanisms for effect of Aldosterone antagonism in the treatment of heart failure with preserved ejection fraction (HF-PEF) using cardiac magnetic resonance imaging. ;Secondary Objective: To determine if echocardiographic measures of diastolic function correlate with those derived from cardiac magnetic resonance imaging and if spironolactone leads to an improvement in markers of diastolic dysfunction and quality of life in HF-PEF.;Primary end point(s): Serial change in ECV, as calculated by T1 map using Cardiac Magnetic Resonance Imaging following treatment with an aldosterone antagonist.;Timepoint(s) of evaluation of this end point: The study will be conducted over 6 months.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): To determine the effect of spironolactone in HF-PEF on:<br> Alternative methods of measuring ECV with CMR<br> Echocardiographically & CMR derived measures of cardiac relaxation<br> Establish correlation betwen change in ECV and measures of cardiac relaxation<br> Exercise tolerance & quality of life<br> ;Timepoint(s) of evaluation of this end point: 6 months