NCT03263962

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

August 23, 2017

Last Update Submit

February 1, 2018

Conditions

Cardiac Heart Failure Patients

Keywords

CHFCanrenone

Outcome Measures

Primary Outcomes (7)

  • Progression of CHF

    Echocardiografic data

    12 years

  • Haemodynamic data

    Systolic blood pressure (SBP, Diastolic blood pressure (DBP), Heart rate (HR)

    12 years

  • Metabolic data

    fasting plasma glucose (FPG), total cholesterol (TC), HDL-cholesterol (HDL-C), triglycerides (Tg), LDL-cholesterol (LDL-C), lipoprotein (a) \[Lp(a)\],

    12 years

  • Renal function

    Sodium, Potassium, Creatinine, Uric acid

    12 years

  • Endocrine data

    Aldosterone, Plasma brain natriuretic peptide (BNP), Plasma renin activity (PRA)

    12 years

  • Cardiovascular mortality

    Register data

    12 years

  • Survival

    Register data

    12 years

Study Arms (2)

With canrenone

Patients with canrenone

Drug: Canrenone

Without canrenone

Patients without canrenone

Interventions

CanrenoneDRUG

Evaluation of canrenone therapy in patients with CHF

With canrenone

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with CHF and preserved systolic function with or without an aldosterone antagonist as canrenone.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

MeSH Terms

Interventions

Canrenone

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FESC

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 28, 2017

Study Start

July 13, 2017

Primary Completion

September 10, 2017

Study Completion

November 30, 2017

Last Updated

February 5, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)