Aldosterone Blockade in Heart Failure

NCT00523757 | Completed Phase 3

• 1 other identifier: UHF-G533000207
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; collagen; diastolic function

Outcome Measures

Primary Outcomes (1)

• LVH

  4 months

Study Arms (2)

1

EXPERIMENTAL

Spironolactone

Drug: Spironolactone

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Spironolactone DRUG

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Justin Ezekowitz: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Justin Ezekowitz, MBBCh MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 31, 2007
• Study Start: August 1, 2007
• Primary Completion: April 30, 2010
• Study Completion: April 30, 2010
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

CA (1)