NCT00861237

Brief Summary

After heart surgery, about 30% of patients suffer from atrial fibrillation. Patients are randomized into two groups receiving either potentized Strychnos Nux vomica or placebo under double blind conditions. Postoperatively, ECGs are done to monitor cardiac rhythm.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

9.3 years

First QC Date

March 12, 2009

Last Update Submit

August 15, 2018

Conditions

Atrial Fibrillation

Keywords

Nux vomicahomeopathyheart lung machineheart surgerypostoperatively studied

Outcome Measures

Primary Outcomes (1)

  • Frequency of atrial fibrillation after heart surgery with heart lung machine

    24 months

Study Arms (2)

Placebo globules group

PLACEBO COMPARATOR

Patients receive Placebo globules made out of sugar and looking similar to active drug sublingually before surgery.

Drug: Placebo (placebo comparator)

Nux vomica group

ACTIVE COMPARATOR

Patients receive Nux vomica globules made out of sugar sublingually before surgery.

Drug: Nux vomica (active comparator)

Interventions

Nux vomica (active comparator)DRUG

Patients receive Nux vomica in a homeopathic potentiation

Also known as: Strychnos Nux vomica C200
Nux vomica group
Placebo (placebo comparator)DRUG

Patients receive Placebo looking similar to active drug

Also known as: Placebo globules
Placebo globules group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients before elective Heart valve - or aortocoronary by pass surgery with heart-lung-machine.

You may not qualify if:

  • Pregnant patients
  • Patients with preoperative atrial fibrillation and/or hyperthyreosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Surgery, Med Univ Vienna

Vienna, A1090, Austria

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Frass, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

July 1, 2008

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

August 16, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)