NCT00206232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

6 years

First QC Date

September 12, 2005

Last Update Submit

February 15, 2013

Conditions

Heart Failure

Keywords

Diastolic Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Six minute walk distance

    Baseline, then 3 and 6 months after randomization

Secondary Outcomes (1)

  • Echocardiography parameters of diastolic function

    Baseline, then 3 and 6 months after randomization

Other Outcomes (5)

  • Procollagen peptides, troponin I, tumor necrosis factor alpha, Brain Natriuretic Peptide

    Baseline then 3 and 6 months after randomization

  • Electrolytes, blood urea nitrogen, creatinine

    Screening and enrollment then 10 days, 4 weeks, 11 weeks, 13 weeks, and 15 weeks after randomization

  • Quality of Life Questionaire

    Baseline, then 3 and 6 months after randomization

  • +2 more other outcomes

Study Arms (2)

Spironolactone

ACTIVE COMPARATOR

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

Drug: Spironolactone

Placebo

PLACEBO COMPARATOR

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

Drug: Spironolactone

Interventions

SpironolactoneDRUG

Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.

Also known as: Aldactone
PlaceboSpironolactone

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine Heart Clinic

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 24905296DERIVED

MeSH Terms

Conditions

Heart FailureHeart Failure, Diastolic

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Karla M Kurrelmeyer, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

July 1, 2004

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

US(1)