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Heart Rate Variability and Hyperthyroidism: Evaluation of the Short-term Effects of Propanolol

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ClinicalTrials.gov Identifier: NCT03393728
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Sobngwi Eugene, Yaounde Central Hospital

Brief Summary:

Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart rate variability in patients with hyperthyroidism.

Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate variability (HRV).

Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours orally for 72 hours.


Condition or disease Intervention/treatment Phase
Hyperthyroidism Drug: Propanolol Phase 4

Detailed Description:

Objective: The aim of our study was to evaluate the short term effects of Propanolol on heart rate variability in patients with hyperthyroidism.

Design: In ten patients newly diagnosed as having hyperthyroidism and naïve of all treatment specific for hyperthyroidism, we evaluated the short term effects of Propanolol on heart rate variability (HRV).

Methods: We measured heart rate variability by power spectral analysis during 2 hours of rest and during Ewing's tests before and after the administration of Propanolol 40mg/12 hours orally for 72 hours. Other outcomes included mean heart rate, mean R-R interval during 2-hour rest.

The study questions the systematic adjunction of Propanolol early in the treatment of hyperthyroidism.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label Before and After design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Term Effects of Propanolol on Heart Rate Variability of Hyperthyroidism
Actual Study Start Date : September 1, 2008
Actual Primary Completion Date : December 30, 2008
Actual Study Completion Date : September 30, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperthyroidism

Arm Intervention/treatment
Experimental: Intervention
72-hour propanolol before specific treatment of hyperthyroidism
Drug: Propanolol
72-hour propanolol before specific treatment of hyperthyroidism
Other Name: Avlocardyl




Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: 72 hours ]
    Sympatho vagal tone measures


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: 72 hours ]
    Heart rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • consenting patients referred to or diagnosed at the National Centre of Obesity of the Yaounde Central Hospital as having hyperthyroidism
  • naïve of all treatment specific for hyperthyroidism.
  • aged 18-70 years

Exclusion Criteria:

  • Patients already under a specific treatment for hyperthyroidism
  • Patients taking beta blockers or any other cardiospecific treatment
  • Patients presenting complications including acute thyrotoxic crisis, or symptomatic cardiac failure
  • Contraindications to the prescription of beta blockers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393728


Sponsors and Collaborators
Yaounde Central Hospital
Investigators
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Study Chair: Jean Claude N Mbanya, MD, PhD Yaounde Central Hospital and University of Yaounde 1
Principal Investigator: Eugène Sobngwi Hôpital Central de Yaoundé et Université de Yaoundé 1

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sobngwi Eugene, Professor of Endocrinology and Metabolism, Yaounde Central Hospital
ClinicalTrials.gov Identifier: NCT03393728     History of Changes
Other Study ID Numbers: YaoundeCH
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Availability to researchers making a formal request with restrictions in relation to national regulations on data sharing

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sobngwi Eugene, Yaounde Central Hospital:
hyperthyroidism
heart rate variability
propanolol
Africa
Additional relevant MeSH terms:
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Propranolol
Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents