NCT00449059

Brief Summary

The aim of the study was to evaluate the acute effect of nitroglycerine infusion on blood pressure and heart rate in heart-transplanted patients with cyclosporine-induced hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jan 2003

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

January 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2007

Completed
Last Updated

March 19, 2007

Status Verified

March 1, 2007

First QC Date

March 15, 2007

Last Update Submit

March 15, 2007

Conditions

HypertensionHeart Transplantation

Keywords

heart transplantationcyclosporinehypertensionnitroglycerin

Outcome Measures

Primary Outcomes (1)

  • Blood pressure reduction after acute nitroglycerine infusion

Secondary Outcomes (1)

  • Heart rate modification after acute nitroglycerine infusion

Interventions

acute infusion of nitroglycerine into the pulmonary arteryDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart-transplanted group:
  • Patients with hypertension and treated with cyclosporine
  • Patients under optimal standard therapy
  • Patients giving written informed consent
  • Control group:
  • Patients with hypertension
  • Patients without prior transplantation of any kind
  • Patients giving written informed consent

You may not qualify if:

  • Hypertensive patients receiving immunosuppressive drugs
  • Patients receiving any kind or nitrate derivates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, CH8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Roberto Corti, MD

    Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 19, 2007

Study Start

January 1, 2003

Study Completion

December 1, 2004

Last Updated

March 19, 2007

Record last verified: 2007-03

Locations

CH(1)