Novel Treatment for Diastolic Heart Failure in Women

• ClinicalTrials.gov Identifier: NCT00206232
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Last Update Posted: February 18, 2013
• Sponsor: Baylor College of Medicine
• Information provided by (Responsible Party): Karla Kurrelmeyer, Baylor College of Medicine

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure	Drug: Spironolactone	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Novel Treatment for Diastolic Heart Failure in Women
• Study Start Date: July 2004
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Spironolactone; Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.	Drug: Spironolactone; Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.; Other Name: Aldactone
Placebo Comparator: Placebo; Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.	Drug: Spironolactone; Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.; Other Name: Aldactone

Outcome Measures

Primary Outcome Measures :

1. Six minute walk distance [ Time Frame: Baseline, then 3 and 6 months after randomization ]

Secondary Outcome Measures :

1. Echocardiography parameters of diastolic function [ Time Frame: Baseline, then 3 and 6 months after randomization ]

Other Outcome Measures:

1. Procollagen peptides, troponin I, tumor necrosis factor alpha, Brain Natriuretic Peptide [ Time Frame: Baseline then 3 and 6 months after randomization ]
2. Electrolytes, blood urea nitrogen, creatinine [ Time Frame: Screening and enrollment then 10 days, 4 weeks, 11 weeks, 13 weeks, and 15 weeks after randomization ]
3. Quality of Life Questionaire [ Time Frame: Baseline, then 3 and 6 months after randomization ]
4. New York Heart Association Classification [ Time Frame: Baseline then 3 and 6 months after randomization ]
5. Number of participants with adverse events [ Time Frame: From randomization until trial completion at 6 months. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Texas

Baylor College of Medicine Heart Clinic

Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

• Principal Investigator: Karla M Kurrelmeyer, MD; Baylor College of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Karla Kurrelmeyer, MD, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT00206232
• Other Study ID Numbers: H - 13988
• First Posted: September 21, 2005
• Last Update Posted: February 18, 2013
• Last Verified: February 2013

Keywords provided by Karla Kurrelmeyer, Baylor College of Medicine:

Diastolic Heart Failure

Additional relevant MeSH terms:

Heart Failure; Heart Failure, Diastolic; Heart Diseases; Cardiovascular Diseases; Spironolactone; Mineralocorticoid Receptor Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents