Heart Failure, Congestive
Conditions
Keywords
aldosterone antagonists, spironolactone, left ventricular remodeling
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.
Detailed description
In the investigators' recent daily clinical practice, they found that the larger dose of the aldosterone antagonist spironolactone combined with a lower dose of an ACE inhibitor and the highest tolerable dose of beta blockers could reverse left ventricular remodeling more effectively than a smaller dose of spironolactone. The ventricular remodeling could get back to normal, especially in patients with none-ischaemic cardiomyopathy. The investigators hypothesize that long term use of a larger dose of the aldosterone antagonist spironolactone could reverse left ventricular remodeling by stimulating new myocyte formation. Thus, they designed this study to verify its efficacy and safety in reversing left ventricular remodeling in severe congestive heart failure in patients with nonischemic cardiomyopathy. To avoid hyperkalemia, the investigators routinely use larger doses of diuretics in combination with a lower dose of an ACE inhibitor to offset the potassium-sparing effects of spironolactone and follow the patients closely.
Interventions
DRUGspironolactone
Sponsors
Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction (LVEF) | — |
| New York Heart Association (NYHA) functional class | — |
| Six-minute walking distance | — |
| Cardiogenic death | — |
| Cardiac thoracic ratio | — |
Countries
China
Outcome results
None listed