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

Effects of Aldosterone Antagonism in Heart Failure with Preserved Ejection Fraction (HF-PEF): Cardiac MRI, Echocardiography, Exercise Physiology & Quality of Life Assessment - Cardiac MRI in HF-PEF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000867-10-GB

Enrollment

Registered

2014-02-13

Start date

2014-02-13

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Spironolactone Product Name: Spironolactone Pharmaceutical Form: Tablet INN or Proposed INN: Spironolactone Pharmaceutical f

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026