NCT00125437

Brief Summary

The purpose of this study is to determine whether a larger dose of the aldosterone antagonist spironolactone combined with a lower dose of an ACE inhibitor is more effective in reverse left ventricular remodeling in severe congestive heart failure in patients with nonischemic cardiomyopathy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 15, 2009

Status Verified

December 1, 2008

First QC Date

July 29, 2005

Last Update Submit

July 13, 2009

Conditions

Heart Failure, Congestive

Keywords

aldosterone antagonistsspironolactoneleft ventricular remodeling

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients whose dilated ventricle reversed to normal (left ventricular end diastolic dimension [LVEDD] defined as <55 mm in males or <50 mm in females and cardiothoracic ratio <50% is normal)

Secondary Outcomes (5)

  • Left ventricular ejection fraction (LVEF)

  • New York Heart Association (NYHA) functional class

  • Six-minute walking distance

  • Cardiogenic death

  • Cardiac thoracic ratio

Interventions

spironolactoneDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New York Heart Association (NYHA) Functional class Ⅲ or Ⅳ
  • Left Ventricular Ejection Fraction (LVEF) \<35%
  • Nonischemic cardiomyopathy
  • Preserved renal function: Cr ≤2.5 mg/dL in males; Cr ≤2.0mg/dL in females

You may not qualify if:

  • Hyperkalemia (≥5.0 mEg/L)
  • Left ventricular systolic dysfunction with pericardial diseases, congenital heart diseases, pulmonary heart diseases, heart valvular diseases, acute coronary syndrome and short life expectancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

MeSH Terms

Conditions

Heart FailureVentricular Remodeling

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kunshen Liu, M.D.

    The First Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 1, 2005

Study Start

September 1, 2005

Study Completion

September 1, 2009

Last Updated

July 15, 2009

Record last verified: 2008-12

Locations

CN(1)