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Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension (OHT)

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ClinicalTrials.gov Identifier: NCT04474899
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : September 27, 2021
Sponsor:
Collaborator:
The University of Western Australia
Information provided by (Responsible Party):
Dr Markus Schlaich, Royal Perth Hospital

Tracking Information
First Submitted Date  ICMJE June 3, 2020
First Posted Date  ICMJE July 17, 2020
Last Update Posted Date September 27, 2021
Actual Study Start Date  ICMJE June 24, 2015
Estimated Primary Completion Date February 24, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
Blood Pressure [ Time Frame: 30 weeks ]
Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2020)
  • blood glucose levels [ Time Frame: 30 weeks ]
    Changes in glycemic control through oral glucose tolerance test
  • Gut microbiota profile [ Time Frame: 30 weeks ]
    Change in gut microbiota assessed by short chain fatty acid
  • Lipid levels in blood [ Time Frame: 30 weeks ]
    change in triglyceride, HDL and LDL levels in blood
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension
Official Title  ICMJE Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension
Brief Summary This study is designed to investigate whether sympathoinhibition with moxonidine could provide added metabolic benefit compared to the second line therapy in the current guidelines.
Detailed Description

This is a randomised, double-blind, cross-over study. Participants will be randomly assigned to receive either moxonidine 0.4mg daily or amlodipine 5mg and will later receive the alternate treatment.

Comprehensive testing will occur after each 12 week treatment phase and will include assessment of muscle sympathetic nerve activity, gut microbiome analysis and metabolic markers.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomized, double blind cross over study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Hypertension
Intervention  ICMJE
  • Drug: Moxonidine 0.4 MG
    Participants will be randomly assigned to receive moxonidine 0.4mg/daily and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.
  • Drug: Amlodipine 5mg
    Participants will be randomly assigned to receive amlodipine 5mg and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.
Study Arms  ICMJE
  • Experimental: Phase 1
    Moxonidine 0.4mg/daily
    Interventions:
    • Drug: Moxonidine 0.4 MG
    • Drug: Amlodipine 5mg
  • Experimental: Phase 2
    Amlodipine 5mg
    Interventions:
    • Drug: Moxonidine 0.4 MG
    • Drug: Amlodipine 5mg
Publications * Carnagarin R, Gregory C, Azzam O, Hillis GS, Schultz C, Watts GF, Bell D, Matthews V, Schlaich MP. The Role of Sympatho-Inhibition in Combination Treatment of Obesity-Related Hypertension. Curr Hypertens Rep. 2017 Oct 28;19(12):99. doi: 10.1007/s11906-017-0795-1. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 24, 2024
Estimated Primary Completion Date February 24, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: 25 -65 years
  • (Body Mass Index) BMI≥30kg/m2
  • Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program)
  • Elevated clinic systolic (Blood Pressure) BP ≥135 or diastolic BP ≥85mmHg,
  • on ACE inhibitor for at least 6 weeks prior to baseline assessment

Exclusion Criteria:

  • Grade 2-3 hypertension (systolic office BP >160, diastolic office BP >100 mmHg)
  • Secondary causes of hypertension
  • CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR<30ml/min}
  • Heart failure NYHA (New York Heart Association) class II-IV
  • Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months) unstable psychiatric condition
  • medication such as corticosteroids, several antidepressants and antipsychotics
  • Female participants of childbearing potential must have a negative pregnancy test prior to treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Revathy Carnagarin, MD +61 8 92240316 revathy.carnagarin@uwa.edu.au
Contact: Anu Joyson, MSN +61 8 92240390 anu.joyson@uwa.edu.au
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04474899
Other Study ID Numbers  ICMJE RA-4-1-7565
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be shared to maintain anonymity and confidentiality of the participants
Responsible Party Dr Markus Schlaich, Royal Perth Hospital
Study Sponsor  ICMJE Royal Perth Hospital
Collaborators  ICMJE The University of Western Australia
Investigators  ICMJE
Principal Investigator: Markus Schlaich, MD University of Western Australia and Royal Perth Hospital
PRS Account Royal Perth Hospital
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP