NCT03895073

Brief Summary

The "four-point" questionnaire by Severo and his associates was weighted in 2011 in the Portuguese population and aims to characterize the severity of the symptoms of heart failure by providing a way to minimize the reliability of the NYHA classification. The questionnaire consists of four closed questions, three possible single-choice answers, coded 0, 1 or 2, and has been translated into Greek in accordance with the internationally-based methodology, with forward-backward translation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

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

September 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 27, 2019

Last Update Submit

March 28, 2019

Conditions

Heart FailureHeart Failure NYHA Class IIIHeart Failure NYHA Class IIHeart Failure NYHA Class IHeart Failure NYHA Class IV

Outcome Measures

Primary Outcomes (1)

  • questionnaire replies

    rating in Severo questionnaire

    1 day

Study Arms (2)

healthy

healthy volunteers' replies to questionnaire

Other: healthy volunteers

heart failure

heart failure patients' replies the questionnaire

Other: healthy volunteers

Interventions

healthy volunteersOTHER

the questionnaire has been assessed by both groups, healthy and heart failure

Also known as: healthy vs heart failure
healthyheart failure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients vs Healthy matched controls

You may qualify if:

  • NYHA classification
  • informed consent
  • compliant with study procedures

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Attikon Hospital

Athens, Attica, Greece

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • John Parissis, MD

    Attikon Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 27, 2019

First Posted

March 29, 2019

Study Start

September 1, 2018

Primary Completion

February 25, 2019

Study Completion

February 25, 2019

Last Updated

March 29, 2019

Record last verified: 2019-03

Locations

GR(1)