Aldosterone Blockade in Heart Failure (ARCTIC-D)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Spironolactone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, collagen, diastolic function
Eligibility Criteria
Inclusion Criteria:
- HF by Framingham criteria
- At least one admission to hospital for HF within the last 180 days
- New York Heart Association Class II thru IV
- Echocardiographic criteria:At least moderate diastolic dysfunction, Ejection fraction >45%
Exclusion Criteria:
- Creatinine clearance <40 mls/min/1.73m2
- Potassium >5.0 mmol/L
- Recent acute coronary syndrome in the prior 4 weeks
- Planned revascularization, defibrillator or pacemaker in next 4 months
- Known previous intolerance to aldosterone antagonist
Sites / Locations
- University of Alberta Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Spironolactone
Outcomes
Primary Outcome Measures
LVH
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00523757
Brief Title
Aldosterone Blockade in Heart Failure
Acronym
ARCTIC-D
Official Title
Aldosterone-blockade Randomized Controlled Trial In CHF - Diastolic
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 30, 2010 (Actual)
Study Completion Date
April 30, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Justin Ezekowitz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Heart failure causes significant morbidity and mortality and is the most rapidly increasing cardiovascular diagnosis in North America overall prevalence is estimated at 0.4% to 2.4%. Recently, heart failure with a preserved ejection fraction (HFNEF) was found in up to 50% of patients with symptomatic heart failure. Many studies have demonstrated that HFNEF has a poor prognosis with a mortality rate of up to 8% per year and a 50% chance of needing to be admitted to hospital in the next year. There are no proven therapies for this type of heart failure.
Aldosterone blockers (these drugs block a hormone that is elevated in patients with heart failure) are used in other types of heart failure. Our goal is to see if this type of drug improves the function of the heart by looking at the thickness of the heart muscle using MRI. Also we will measure the amount of tissue formation and breakdown in the heart. The trial will be done using both the drug and a placebo so that we can see what effects are due to the drug.
Detailed Description
Aldosterone antagonists have shown efficacy in systolic heart failure and in patients with post-myocardial infarction systolic dysfunction in three major randomized placebo controlled trials. Together these trials have demonstrated a reduction in mortality, hospitalization and a regression in left ventricular mass by MRI.
Primary Objective The primary objective of this study will be to assess the change in markers of collagen turnover and correlate this with specific measures of left ventricular mass regression and diastolic function on MRI after 4 months of aldosterone blockade.
Study Design and Methods This study is a double-blind, concealed allocation, randomized trial at the University of Alberta where patients with diastolic heart failure will be randomized to spironolactone or matching placebo for 4 months. Outcomes assessed include LV mass by MRI, collagen markers, other biomarkers, clinical outcomes, quality of life and exercise testing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, collagen, diastolic function
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Spironolactone
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
LVH
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HF by Framingham criteria
At least one admission to hospital for HF within the last 180 days
New York Heart Association Class II thru IV
Echocardiographic criteria:At least moderate diastolic dysfunction, Ejection fraction >45%
Exclusion Criteria:
Creatinine clearance <40 mls/min/1.73m2
Potassium >5.0 mmol/L
Recent acute coronary syndrome in the prior 4 weeks
Planned revascularization, defibrillator or pacemaker in next 4 months
Known previous intolerance to aldosterone antagonist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Ezekowitz, MBBCh MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
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Aldosterone Blockade in Heart Failure
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