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Novel Treatment for Diastolic Heart Failure in Women
This study is currently recruiting participants.
Verified by Baylor College of Medicine, August 2005
Sponsored by: Baylor College of Medicine
Information provided by: Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00206232
  Purpose

The purpose of the study is to collect information about the potential benefit and safety of low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine whether spironolactone can cause the patient's condition to improve.


Condition Intervention Phase
Heart Failure
Drug: Spironolactone
Phase IV

MedlinePlus related topics: Heart Failure
Drug Information available for: Spironolactone
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Novel Treatment for Diastolic Heart Failure in Women

Further study details as provided by Baylor College of Medicine:

Study Start Date: July 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Patient is 18 years of age or older.
  • Patient has CHF for > 2 months
  • Patient has LVEF > 50% within 2 months
  • Patient with NYHA class II or III
  • BNP > 62 pg/ml within 2 months of screening
  • Patient on ACEI or ARB therapy for at least 1 month
  • BP no more than 150/95
  • Patient able to walk
  • Signed informed consent.

Exclusion Criteria:

  • Current treatment with spironolactone.
  • Severe hepatic impairment.
  • Creatinine > 2.5 mg/dl
  • Potassium > 5.0 mEq/L
  • Intolerance to spironolactone in the past.
  • Significant valvular heart disease, pericardial disease, or severe COPD.
  • Unstable angina or MI within the past 4 weeks.
  • Severe vascular disease.
  • Pregnant or lactating females.
  • History of alcohol or substance abuse.
  • History of cancer.
  • Participation in any other drug trial within 30 days prior to randomization.
  • Inability to provide informed consent.
  • Patient on any CYP3A4s.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206232

Contacts
Contact: Karla M Kurrelmeyer, MD 713-798-1405 karlak@bcm.tmc.edu
Contact: Yelena Melendez, BBM 713-790-6220 melendez@bcm.tmc.edu

Locations
United States, Texas
Baylor College of Medicine Heart Clinic Recruiting
Houston, Texas, United States, 77030
Contact: Yelena Melendez, BBM     713-790-6220     melendez@bcm.tmc.edu    
Principal Investigator: Karla M Kurrelmeyer, MD            
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Karla M Kurrelmeyer, MD Baylor College of Medicine
  More Information

Study ID Numbers: H - 13988
Study First Received: September 12, 2005
Last Updated: October 30, 2007
ClinicalTrials.gov Identifier: NCT00206232  
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Diastolic Heart Failure

Study placed in the following topic categories:
Heart Failure, Diastolic
Heart Failure
Heart Diseases
Spironolactone

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

ClinicalTrials.gov processed this record on January 16, 2009