NCT00865917

Brief Summary

The study compares three treatment modalities in a human model of Postural orthostatic tachycardia syndrome (POTS): beta-blockers, I(f)-blockers, and placebo.

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
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

2 active sites

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

November 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

2 years

First QC Date

March 18, 2009

Last Update Submit

March 18, 2009

Conditions

Postural Orthostatic Tachycardia Syndrome

Keywords

POTS

Outcome Measures

Primary Outcomes (1)

  • Sub-study 'Orthostatic tolerance': Change in heart rate after 20 mins of passive orthostasis. Sub-study 'Sympathetic system': arterial pressure related heart rate

    12-18 hours

Secondary Outcomes (2)

  • 'Orthostatic tolerance': Hemodynamics during head-up tilt. Time to presyncope.

    12-18 hours

  • 'Sympathetic system': Muscle sympathetic nerve activity (MSNA).

    12-18 hours

Study Arms (3)

1

ACTIVE COMPARATOR

beta-blocker

Drug: beta-blocker (Metoprolol)

2

EXPERIMENTAL

I(f)-blocker

Drug: I(f)-blocker (ivabradine)

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

beta-blocker (Metoprolol)DRUG

Metoprolol 95 mg once per day

1
I(f)-blocker (ivabradine)DRUG

ivabradine 7.5 mg once per day

2
PlaceboDRUG

matching appearance

3

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male
  • age 18-40 years
  • BMI: 18-30 kg/m²
  • arterial blood pressure \<=160/100 mm Hg
  • co-operativity
  • voluntariness

You may not qualify if:

  • conditions in which treatment might be ineffective or insecure
  • co-medication within the last 4 weeks
  • participation in another clinical trial within the last 4 weeks
  • unability to understand the study's aim
  • drug or alcohol abuse
  • secondary hypertension
  • creatinine \> 130 μM (1.47 mg/dl)
  • GOT/GPT \> 2 times normal
  • GGT \> 3 times normal
  • contraindications against reboxetine, beta-blocker, ivabradine
  • asthma, psoriasis
  • diabetes
  • heart failure (NYHA III or IV)
  • coronary artery disease
  • peripheral occlusive disease
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Franz-Volhard Centrum für Klinische Forschung

Berlin, 13125, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Related Publications (2)

  • Heusser K, Tank J, Brinkmann J, Schroeder C, May M, Grosshennig A, Wenzel D, Diedrich A, Sweep FC, Mehling H, Luft FC, Jordan J. Preserved Autonomic Cardiovascular Regulation With Cardiac Pacemaker Inhibition: A Crossover Trial Using High-Fidelity Cardiovascular Phenotyping. J Am Heart Assoc. 2016 Jan 13;5(1):e002674. doi: 10.1161/JAHA.115.002674.

    PMID: 26764413DERIVED

  • Zoerner AA, Schroeder C, Kayacelebi AA, Suchy MT, Gutzki FM, Stichtenoth DO, Tank J, Jordan J, Tsikas D. A validated, rapid UPLC-MS/MS method for simultaneous ivabradine, reboxetine, and metoprolol analysis in human plasma and its application to clinical trial samples. J Chromatogr B Analyt Technol Biomed Life Sci. 2013 May 15;927:105-11. doi: 10.1016/j.jchromb.2013.01.016. Epub 2013 Jan 29.

    PMID: 23434314DERIVED

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Adrenergic beta-AntagonistsMetoprololIvabradine

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jens Jordan, MD

    Hannover Medical School

    STUDY DIRECTOR

Central Study Contacts

Heidrun Mehling, MD

CONTACT

+49(0)30

Jens Tank, MD

CONTACT

+49(0)511

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 19, 2009

Study Start

November 1, 2008

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

March 19, 2009

Record last verified: 2009-03

Locations

DE(2)