Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure (the Coffee-it Study)

NCT ID: NCT03263962

Last Updated: 2018-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

502 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-13

Study Completion Date

2017-11-30

Brief Summary

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To evaluate canrenone effects compared to other therapies on cardiovascular mortality in patients with congestive heart failure and preserved systolic function after 12 years of evaluation.

Detailed Description

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The investigators will verify patients with cardiac heart failure (CHF) and preserved systolic function and each patient must have all clinical evaluation through basal measurements of blood pressure, heart rate, biochemical tests, and color Doppler echocardiographic parameters for at least 12 years.

The investigators will evaluate the effects of an aldosterone antagonist as canrenone compared to a group without canrenone and the investogators will verify how many patients reported cardiovascular mortality or will survive.

Conditions

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Cardiac Heart Failure Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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With canrenone

Patients with canrenone

Canrenone

Intervention Type DRUG

Evaluation of canrenone therapy in patients with CHF

Without canrenone

Patients without canrenone

No interventions assigned to this group

Interventions

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Canrenone

Evaluation of canrenone therapy in patients with CHF

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with CHF
* preserved systolic function (FE ≥ 45%)

Exclusion Criteria

* severe hypertension identified by blood pressure ≥180/110 mmHg
* patients with impaired systolic function (FE \< 45%)
* history of active hepatitis or cirrhosis
* impaired renal function
* hyperpotassemia
* diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Derosa

MD, PhD, FESC

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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20170016069

Identifier Type: -

Identifier Source: org_study_id

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