EUCTR2013-000867-10-GB
Active, not recruiting
Phase 1
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
niversity of Leeds0 sites51 target enrollmentFebruary 13, 2014
DrugsSpironolactone
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Leeds
- Enrollment
- 51
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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Establishing the benefits of a tablet commonly used to treat raised blood pressure in people with Chronic Kidney Disease stage 3b.We plan a large pragmatic trial to test the potential for spironolactone to to reduce overall cardiovascular events and death, to delay the decline in renal function, and to improve surrogate markers for vascular disease in people with stage 3b (eGFR 30-44 ml/min/1.73m2)Chronic Kidney Disease.MedDRA version: 15.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857MedDRA version: 15.1Level: PTClassification code 10018355Term: Glomerular filtration rateSystem Organ Class: 10022891 - InvestigationsMedDRA version: 15.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]EUCTR2012-002672-13-GBniversity of Oxford, Clinical Trials and Research Governance Office2,616