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Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT)

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Trial Conditions
  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Failure, Congestive
What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
50 and older

Gender:
Both

Eligibility

INCLUSION CRITERIA:

- Heart failure as defined by at least one of the following symptoms at the time of
screening and at least one of the following signs within 12 months prior to study
entry:

1. SYMPTOMS:

1. Paroxysmal nocturnal dyspnea

2. Orthopnea

3. Dyspnea on mild or moderate exertion

2. SIGNS:

1. Any rales post cough

2. Jugular venous pressure(JVP) greater than or equal to 10 cm H2O

3. Lower extremity edema

4. Chest x-ray demonstrating pleural effusion, pulmonary congestion, or
cardiomegaly

- Left ventricular ejection fraction (ideally obtained by echocardiography, although
radionuclide ventriculography and angiography are acceptable) greater than or equal
to 45% (per local reading); the ejection fraction must have been obtained within 6
months prior to randomization and after any MI or other event that would affect
ejection fraction

- Controlled systolic blood pressure(BP), defined as a target systolic BP less than 140
mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment
if they are on three or more medications to control BP

- Serum potassium less than 5.0 mmol/L prior to randomization

- At least one hospital admission for which heart failure was a major component of the
hospitalization some time within the 12 months prior to study entry (transient heart
failure in the context of MI does not qualify) OR brain natriuretic peptide (BNP)
greater than or equal to 100 pg/ml or N-terminal pro-BNP greater than or equal to 360
pg/ml (not explained by another disease entity) within the 60 days prior to study
entry

- Women of child-bearing potential must have a negative serum/urine pregnancy test
within 72 hours prior to randomization, must not be lactating, and must agree to use
an effective method of contraception during the entire course of study participation

- Willing to comply with scheduled visits

- Informed consent form signed by the subject prior to participation in the trial

EXCLUSION CRITERIA:

- Severe systemic illness with an expected life expectancy of less than 3 years

- Chronic pulmonary disease requiring home O2, oral steroid therapy, or hospitalization
for exacerbation within 12 months of study entry, or significant chronic pulmonary
disease in the opinion of the investigator

- Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial
constriction

- Primary hemodynamically significant uncorrected valvular heart disease, obstructive
or regurgitant, or any valvular disease expected to lead to surgery during the trial

- Atrial fibrillation with a resting heart rate greater than 90 bpm

- MI in the past 90 days

- Coronary artery bypass graft surgery in the past 90 days

- Percutaneous coronary intervention in the past 30 days

- Heart transplant recipient

- Currently implanted left ventricular assist device

- Stroke in past 90 days

- Systolic BP (SBP) greater than 160 mm Hg

- Known orthostatic hypotension

- Gastrointestinal disorder that could interfere with study drug absorption

- Use of any aldosterone antagonist or potassium sparing medication in the last 14 days
or any known condition that would require the use of an aldosterone antagonist during
study participation;

- Known intolerance to aldosterone antagonists

- Current lithium use

- Current participation (including prior 30 days) in any other therapeutic trial

- Any condition that, in the opinion of the investigator, may prevent the participant
from adhering to the trial protocol

- History of hyperkalemia (serum potassium greater than or equal to 5.5 mmol/L) in the
past 6 months or serum potassium greater than or equal to 5.0 mmol/L within the past
2 weeks

- Severe renal dysfunction, defined as an estimated glomerular filtration rate(GFR)
less than 30 ml/min (per the Modification of Diet in Renal Disease (MDRD) 4-component
study equation). Participants with serum creatinine greater than or equal to 2.5
mg/dl are also excluded even if their GFR is greater than or equal to 30 ml/min

- Known chronic hepatic disease, defined as aspartate aminotransferase(AST) and alanine
aminotransferase(ALT) levels greater than 3.0 times the upper limit of normal as read
at the local lab

Gender: Both
Steward Physician(s)
  • Sonja M. McKinlay, PhD
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Drug
  • Spironolactone (an aldosterone antagonist)
  • Placebo
Physician Researcher

Investigator Name:

  • Sonja M. McKinlay, PhD

Other Information

Sponsor: New England Research Institutes
Phase: Phase 3
Trial ID: NCT00094302
Volunteers:  Not Accepting Healthy Volunteers

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