Novel Treatment for Diastolic Heart Failure in Women

February 15, 2013 updated by: Karla Kurrelmeyer, Baylor College of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine Heart Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Aldactone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Six minute walk distance
Time Frame: Baseline, then 3 and 6 months after randomization
Baseline, then 3 and 6 months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Echocardiography parameters of diastolic function
Time Frame: Baseline, then 3 and 6 months after randomization
Baseline, then 3 and 6 months after randomization

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 15, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H - 13988

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Spironolactone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe