Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Obesity Hypertension Drug: Moxonidine 0.4 MG Drug: Amlodipine 5mg Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Official Title: Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension
Actual Study Start Date : June 24, 2015
Estimated Primary Completion Date : February 24, 2024
Estimated Study Completion Date : June 24, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Amlodipine

Arm Intervention/treatment
Experimental: Phase 1
Moxonidine 0.4mg/daily
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.

Experimental: Phase 2
Amlodipine 5mg
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.




Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: 30 weeks ]
    Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring


Secondary Outcome Measures :
  1. blood glucose levels [ Time Frame: 30 weeks ]
    Changes in glycemic control through oral glucose tolerance test

  2. Gut microbiota profile [ Time Frame: 30 weeks ]
    Change in gut microbiota assessed by short chain fatty acid

  3. Lipid levels in blood [ Time Frame: 30 weeks ]
    change in triglyceride, HDL and LDL levels in blood



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04474899


Contacts
Layout table for location contacts
Contact: Revathy Carnagarin, MD +61 8 92240316 revathy.carnagarin@uwa.edu.au
Contact: Anu Joyson, MSN +61 8 92240390 anu.joyson@uwa.edu.au

Locations
Layout table for location information
Australia, Western Australia
Dobney Hypertension Centre Recruiting
Perth, Western Australia, Australia, 6155
Contact: Markus Schlaich    +61 8 92240390    markus.schlaich@uwa.edu.au   
Contact: Revathy Carnagarin    +61 8 92240316    revathy.carnagarin@uwa.edu.au   
Principal Investigator: Markus Schlaich         
Sub-Investigator: Revathy Carnagarin         
Sponsors and Collaborators
Royal Perth Hospital
The University of Western Australia
Investigators
Layout table for investigator information
Principal Investigator: Markus Schlaich, MD University of Western Australia and Royal Perth Hospital
Publications:
Layout table for additonal information
Responsible Party: Dr Markus Schlaich, Principal Investigator, Royal Perth Hospital
ClinicalTrials.gov Identifier: NCT04474899    
Other Study ID Numbers: RA-4-1-7565
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be shared to maintain anonymity and confidentiality of the participants

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Obesity
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Amlodipine
Moxonidine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents