NCT00782782

Brief Summary

Congestive Heart failure (CHF) is asociated with changes in cardiac function and vascular responses. The aim of this study is to characterize these differences. Our hypothesis is, that there are differences in vascular responses between healthy subjects and patients with CHF.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 31, 2008

Status Verified

October 1, 2008

Enrollment Period

1.3 years

First QC Date

October 26, 2008

Last Update Submit

October 28, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • vascular sensitivity (ED50) and response (Emax) to dexmedetomidine, phenylephrine, isoproterenol and terbutaline

    3 weeks

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with congestive heart failure NYHA I-II and healthy subjects

You may qualify if:

  • Patients with congestive heart failure NYHA I-II
  • Stable clinical condition

You may not qualify if:

  • Resting systolic blood pressure \< 100
  • Resting heart rate \< 50
  • Hypersensitivity to dexmedetomidine, phenylephrine, isoproterenol, terbutaline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah University Hospital

Jerusalem, 92110, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

samples for norepinephrine and PRA will be retained

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Mordechai Muszkat

    Hadassah University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 26, 2008

First Posted

October 31, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2011

Last Updated

October 31, 2008

Record last verified: 2008-10

Locations