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Estrogen, Cytokines and Heart Failure in Women

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00041431
Collaborator
(none)
24
Duration (Months)

Study Details

Study Description

Brief Summary

To determine the effects of estrogen therapy on postmenopausal women with congestive heart failure.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hormone Replacement Therapy
 N/A

Detailed Description

BACKGROUND:

Congestive heart failure (CHF) is a leading cause of morbidity, mortality, and hospitalization in women. The increase in mortality suggests that postmenopausal estrogen loss may alter the phenotypic expression of CHF. Because estrogen is a potent in vitro inhibitor of pro-inflammatory cytokines (e.g., TNFa, IL-1B, IL-6), which are re-expressed by the failing myocardium in patients with CHF and are related to an adverse prognosis, the study postulates that estrogen replacement will improve the outcome of postmenopausal women with CHF.

DESIGN NARRATIVE:

The randomized, double blind study was conducted in 166 postmenopausal women with congestive heart failure due to idiopathic (i.e.nonischemic) dilated cardiomyopathy and NYHA class II or III symptoms on either combined estrogen and progestin or placebo. Women maintained their then current congestive heart failure medications for six months. Three outcomes were measured: 1) Congestive heart failure severity/functional capacity quantified by maximum oxygen consumption during metabolic stress testing; 2) Left and right ventricular remodeling quantified by electron bean CT scan; 3) quality of life assessment by the Minnesota Living with Heart Failure and Kansas City cardiomyopathy questionnaires. In addition, measurements were made of pro-inflammatory markers, that had been demonstrated to be elevated in congestive heart failure to assess whether hormone replacement therapy reduced them.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Study Start Date :
Dec 1, 2001
Actual Study Completion Date :
Dec 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 100 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    Postmenopausal women with NYHA Class II or Class III congestive heart failure due to idiopathic dilated cardiomyopathy.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • : Steven Reis, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00041431
    Other Study ID Numbers:
    • 1181
    • R01HL068939
    First Posted:
    Jul 9, 2002
    Last Update Posted:
    May 13, 2016
    Last Verified:
    May 1, 2005
    Additional relevant MeSH terms:
    Heart Failure
    Cardiovascular Diseases
    Heart Diseases
    Hormones

    Study Results

    No Results Posted as of May 13, 2016