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NCT00663195 Clinical Trial

Effects of Spironolactone on Matrix Metalloproteinases (MMPs) in Heart Failure

Chronic Stable Heart Failure Clinical Trial

Official title:
Effects of Spironolactone on Circulating MMPs in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00663195
Other study ID # #344
Secondary ID
Status Completed
Phase Phase 4
First received April 18, 2008
Last updated April 18, 2008
Start date January 2004
Est. completion date December 2005

Study information
Verified date April 2008
Source Tottori University Hospital
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels and insulin resistance in patients with chronic heart failure.

Description:

Myocardial fibrosis is observed in failing hearts. MMPs are considered markers of fibrosis. Recently, circulating MMPs can be measured and are elevated in patients with chronic heart failure (CHF). It has been reported that spironolactone improves myocardial fibrosis in CHF animal models. Therefore, the purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels in patients with chronic heart failure.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- chronic stable heart failure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• spironolactone + furosemide
spironolactone 25mg/day, 16 weeks and furosemide 20mg/day, 16 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tottori University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary MMP levels 16 weeks
See also
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Withdrawn NCT04507347 - Efficacy and Safety of TRC041266 in Patients With Heart Failure, LVEF ≥40%, Diastolic Dysfunction and Type 2 Diabetes Mellitus Phase 3
Completed NCT02204449 - Cardiac Rehabilitation Peer Mentorship N/A
Completed NCT00664222 - Spironolactone and Insulin Resistance in Chronic Heart Failure (CHF) Phase 4
Completed NCT00663494 - Matrix Metalloproteinase (MMP) in Heart Failure N/A
Recruiting NCT05034549 - Noninvasive Ventilation for Chronic Heart Failure N/A
Recruiting NCT01065194 - Efficacy and Safety of Pulsed Infusions of Levosimendan in Outpatients With Advanced Heart Failure Phase 3