NCT02406716

Brief Summary

This study hypothesis is that Semaphorins 3A and 4D levels are overexpressed in patients with heart failure. Study protocol: Hospitallized patients with new onset or previously diagnosed heart failure will be recruited to the study. Control group will include healthy people with no medical records or chronic treatment at the same age range. After signing an informed constent form, full medical history and blood samples will be collected. A second blood sample will be collected 8 weeks later, assuming the patient was discharged and not hospitalized since than. The blood samples will be analyzed by Bnai Zion Medical Center Immunology labs for the above semaphorins levels in the heart failure group and control group. Statistical analysis will then commence for possible correlatoion with different clinical parameters.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

March 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

March 29, 2015

Last Update Submit

March 30, 2015

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Semaphrone 3A and 4D levels

    one year

Secondary Outcomes (1)

  • BNP level

    one year

Study Arms (2)

HF

Heart failure patients

Other: Biospecimen retention

Controls

Healthy donors

Other: Biospecimen retention

Interventions

Biospecimen retentionOTHER
ControlsHF

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with new onset or previously diagnosed heart failure

You may qualify if:

  • Patients with new onset or previously diagnosed heart failure.
  • Heart failure diagnosis can be based on clinical judgment, echocardiography or elevated BNP levels

You may not qualify if:

  • Patients with acute myocardial infarction diagnosed clinicly and labratory

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Zahava Vadas, MD. PHD.

    Bnai Zion Medical Center, Immunology devision

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadav Willner, MD.

CONTACT

9720543249856nadav.willner@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2015

First Posted

April 2, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

April 2, 2015

Record last verified: 2015-03