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

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ClinicalTrials.gov Identifier: NCT03263962
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Giuseppe Derosa, University of Pavia

Tracking Information
First Submitted Date August 23, 2017
First Posted Date August 28, 2017
Last Update Posted Date February 5, 2018
Actual Study Start Date July 13, 2017
Actual Primary Completion Date September 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2017)
  • Progression of CHF [ Time Frame: 12 years ]
    Echocardiografic data
  • Haemodynamic data [ Time Frame: 12 years ]
    Systolic blood pressure (SBP, Diastolic blood pressure (DBP), Heart rate (HR)
  • Metabolic data [ Time Frame: 12 years ]
    fasting plasma glucose (FPG), total cholesterol (TC), HDL-cholesterol (HDL-C), triglycerides (Tg), LDL-cholesterol (LDL-C), lipoprotein (a) [Lp(a)],
  • Renal function [ Time Frame: 12 years ]
    Sodium, Potassium, Creatinine, Uric acid
  • Endocrine data [ Time Frame: 12 years ]
    Aldosterone, Plasma brain natriuretic peptide (BNP), Plasma renin activity (PRA)
  • Cardiovascular mortality [ Time Frame: 12 years ]
    Register data
  • Survival [ Time Frame: 12 years ]
    Register data
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03263962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure (the Coffee-it Study)
Official Title Canrenone Effects on Cardiovascular Mortality in Patients With Congestive Heart Failure: the Coffee-it Study
Brief Summary 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

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with CHF and preserved systolic function with or without an aldosterone antagonist as canrenone.
Condition Cardiac Heart Failure Patients
Intervention Drug: Canrenone
Evaluation of canrenone therapy in patients with CHF
Study Groups/Cohorts
  • With canrenone
    Patients with canrenone
    Intervention: Drug: Canrenone
  • Without canrenone
    Patients without canrenone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 1, 2018)
502
Original Estimated Enrollment
 (submitted: August 23, 2017)
600
Actual Study Completion Date November 30, 2017
Actual Primary Completion Date September 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03263962
Other Study ID Numbers 20170016069
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Giuseppe Derosa, University of Pavia
Study Sponsor University of Pavia
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Pavia
Verification Date February 2018