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Novel Treatment for Diastolic Heart Failure in Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karla Kurrelmeyer, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00206232
First received: September 12, 2005
Last updated: February 15, 2013
Last verified: February 2013

September 12, 2005
February 15, 2013
July 2004
July 2010   (final data collection date for primary outcome measure)
Six minute walk distance [ Time Frame: Baseline, then 3 and 6 months after randomization ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00206232 on ClinicalTrials.gov Archive Site
Echocardiography parameters of diastolic function [ Time Frame: Baseline, then 3 and 6 months after randomization ] [ Designated as safety issue: No ]
Not Provided
  • Procollagen peptides, troponin I, tumor necrosis factor alpha, Brain Natriuretic Peptide [ Time Frame: Baseline then 3 and 6 months after randomization ] [ Designated as safety issue: No ]
  • Electrolytes, blood urea nitrogen, creatinine [ Time Frame: Screening and enrollment then 10 days, 4 weeks, 11 weeks, 13 weeks, and 15 weeks after randomization ] [ Designated as safety issue: Yes ]
  • Quality of Life Questionaire [ Time Frame: Baseline, then 3 and 6 months after randomization ] [ Designated as safety issue: No ]
  • New York Heart Association Classification [ Time Frame: Baseline then 3 and 6 months after randomization ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: From randomization until trial completion at 6 months. ] [ Designated as safety issue: Yes ]
Not Provided
 
Novel Treatment for Diastolic Heart Failure in Women
Novel Treatment for Diastolic Heart Failure in Women

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.

Subjects with diastolic heart failure defined based on clinical symptoms, echocardiography diastology parameters and brain natriuretic peptide level will be randomized in a 1:1 fashion to either placebo or spironolactone 25mg daily for 6 months. They will be assessed over this 6 month period for improvement in exercise capacity, clinical symptoms, echocardiography diastology parameters, and biomarkers specific for heart failure. Safety of spironolactone in this patient population will also be assessed by recording adverse events and following electrolytes, blood urea nitrogen, and creatinine levels.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Heart Failure
Drug: Spironolactone
Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.
Other Name: Aldactone
  • Active Comparator: Spironolactone
    Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.
    Intervention: Drug: Spironolactone
  • Placebo Comparator: Placebo
    Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.
    Intervention: Drug: Spironolactone
Kurrelmeyer KM, Ashton Y, Xu J, Nagueh SF, Torre-Amione G, Deswal A. Effects of spironolactone treatment in elderly women with heart failure and preserved left ventricular ejection fraction. J Card Fail. 2014 Aug;20(8):560-8. doi: 10.1016/j.cardfail.2014.05.010. Epub 2014 Jun 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women who are 18 years of age or older.
  • Women with clinical heart failure for > 2 months.
  • Women with left ventricular ejection fraction > 50% within 2 months of screening.
  • Women with New York Heart Association class II or III heart failure symptoms.
  • Brain Natriuretic Peptide > 62 pg/ml within 2 months of screening.
  • Patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy for at least 1 month.
  • Blood Pressure no more than 150/95.
  • Patient able to walk more than 50 meters at the time of enrollment.
  • 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 chronic lung disease with cor pulmonale.
  • Unstable angina or myocardial infarction within the past 4 weeks.
  • Severe peripheral vascular disease or other physical conditions that would limit the walking distance.
  • Pregnant or lactating females.
  • Participation in any other drug trial within 30 days prior to randomization.
  • Inability to provide informed consent.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00206232
H - 13988
No
Karla Kurrelmeyer, Baylor College of Medicine
Baylor College of Medicine
Not Provided
Principal Investigator: Karla M Kurrelmeyer, MD Baylor College of Medicine
Baylor College of Medicine
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP