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Aldosterone Blockade in Heart Failure (ARCTIC-D)
This study is currently recruiting participants.
Verified by University of Alberta, July 2009
First Received: August 29, 2007   Last Updated: July 20, 2009   History of Changes
Sponsor: University of Alberta
Information provided by: University of Alberta
ClinicalTrials.gov Identifier: NCT00523757
  Purpose

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.


Condition Intervention Phase
Heart Failure
 Drug: Spironolactone
Drug: Placebo
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aldosterone-blockade Randomized Controlled Trial In CHF - Diastolic

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
Drug Information available for: Spironolactone Aldosterone
U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • LVH [ Time Frame: 4 months ]

Estimated Enrollment: 10
Study Start Date: August 2007
Estimated Study Completion Date: August 2008
Arms Assigned Interventions
1: Experimental
Spironolactone
Drug: Spironolactone
2: Placebo Comparator Drug: Placebo

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HF by Framingham criteria
  2. At least one admission to hospital for HF within the last 180 days
  3. New York Heart Association Class II thru IV
  4. Echocardiographic criteria:At least moderate diastolic dysfunction, Ejection fraction >45%

Exclusion Criteria:

  1. Creatinine clearance <40 mls/min/1.73m2
  2. Potassium >5.0 mmol/L
  3. Recent acute coronary syndrome in the prior 4 weeks
  4. Planned revascularization, defibrillator or pacemaker in next 4 months
  5. Known previous intolerance to aldosterone antagonist
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523757

Contacts
Contact: Justin Ezekowitz, MBBCh MSc 7804078719 jae2@ualberta.ca

Locations
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Contact: Justin Ezekowitz, MBBCh MSc     7804078719        
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Justin Ezekowitz, MBBCh MSc University of Alberta
  More Information

No publications provided

Study ID Numbers: UHF-G533000207
Study First Received: August 29, 2007
Last Updated: July 20, 2009
ClinicalTrials.gov Identifier: NCT00523757     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
heart failure
collagen
diastolic function

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Hormone Antagonists
Diuretics
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Agents
 Pharmacologic Actions
Spironolactone
Aldosterone Antagonists
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on March 18, 2010



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