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Novel Treatment for Diastolic Heart Failure in Women

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Spironolactone
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Diastolic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Baylor College of Medicine Heart Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Spironolactone

Placebo

Arm Description

Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.

Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.

Outcomes

Primary Outcome Measures

Six minute walk distance

Secondary Outcome Measures

Echocardiography parameters of diastolic function

Full Information

First Posted
September 12, 2005
Last Updated
February 15, 2013
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00206232
Brief Title
Novel Treatment for Diastolic Heart Failure in Women
Official Title
Novel Treatment for Diastolic Heart Failure in Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Diastolic Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spironolactone
Arm Type
Active Comparator
Arm Description
Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Other Intervention Name(s)
Aldactone
Intervention Description
Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.
Primary Outcome Measure Information:
Title
Six minute walk distance
Time Frame
Baseline, then 3 and 6 months after randomization
Secondary Outcome Measure Information:
Title
Echocardiography parameters of diastolic function
Time Frame
Baseline, then 3 and 6 months after randomization
Other Pre-specified Outcome Measures:
Title
Procollagen peptides, troponin I, tumor necrosis factor alpha, Brain Natriuretic Peptide
Time Frame
Baseline then 3 and 6 months after randomization
Title
Electrolytes, blood urea nitrogen, creatinine
Time Frame
Screening and enrollment then 10 days, 4 weeks, 11 weeks, 13 weeks, and 15 weeks after randomization
Title
Quality of Life Questionaire
Time Frame
Baseline, then 3 and 6 months after randomization
Title
New York Heart Association Classification
Time Frame
Baseline then 3 and 6 months after randomization
Title
Number of participants with adverse events
Time Frame
From randomization until trial completion at 6 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karla M Kurrelmeyer, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine Heart Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24905296
Citation
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.
Results Reference
derived

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Novel Treatment for Diastolic Heart Failure in Women

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