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

Primary Purpose

Obesity, Hypertension

Status

Recruiting

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

Moxonidine 0.4 MG

Amlodipine 5mg

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: 25 -70 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

Sites / Locations

Dobney Hypertension CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Phase 1

Phase 2

Arm Description

Moxonidine 0.4mg/daily

Amlodipine 5mg

Outcomes

Primary Outcome Measures

Blood Pressure

Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring

Secondary Outcome Measures

blood glucose levels

Changes in glycemic control through oral glucose tolerance test

Gut microbiota profile

Change in gut microbiota assessed by short chain fatty acid

Lipid levels in blood

change in triglyceride, HDL and LDL levels in blood

Full Information

NCT ID

NCT04474899

First Posted

June 3, 2020

Last Updated

September 28, 2022

Sponsor

Royal Perth Hospital

Collaborators

The University of Western Australia

1. Study Identification

Unique Protocol Identification Number

NCT04474899

Brief Title

Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

Acronym

OHT

Official Title

Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 24, 2015 (Actual)

Primary Completion Date

February 24, 2024 (Anticipated)

Study Completion Date

June 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Royal Perth Hospital

Collaborators

The University of Western Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

Randomized, double blind cross over study

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double (Participant, Investigator)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phase 1

Arm Type

Experimental

Arm Description

Moxonidine 0.4mg/daily

Arm Title

Phase 2

Arm Type

Experimental

Arm Description

Amlodipine 5mg

Intervention Type

Drug

Intervention Name(s)

Moxonidine 0.4 MG

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Amlodipine 5mg

Intervention Description

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 Measure Information:

Title

Blood Pressure

Description

Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring

Time Frame

30 weeks

Secondary Outcome Measure Information:

Title

blood glucose levels

Description

Changes in glycemic control through oral glucose tolerance test

Time Frame

30 weeks

Title

Gut microbiota profile

Description

Change in gut microbiota assessed by short chain fatty acid

Time Frame

30 weeks

Title

Lipid levels in blood

Description

change in triglyceride, HDL and LDL levels in blood

Time Frame

30 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 25 -70 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Revathy Carnagarin, MD

Phone

+61 8 92240316

revathy.carnagarin@uwa.edu.au

First Name & Middle Initial & Last Name or Official Title & Degree

Anu Joyson, MSN

Phone

+61 8 92240390

anu.joyson@uwa.edu.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markus Schlaich, MD

Organizational Affiliation

University of Western Australia and Royal Perth Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dobney Hypertension Centre

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6155

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Markus Schlaich

Phone

+61 8 92240390

markus.schlaich@uwa.edu.au

First Name & Middle Initial & Last Name & Degree

Revathy Carnagarin

Phone

+61 8 92240316

revathy.carnagarin@uwa.edu.au

First Name & Middle Initial & Last Name & Degree

Markus Schlaich

First Name & Middle Initial & Last Name & Degree

Revathy Carnagarin

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual Participant Data will not be shared to maintain anonymity and confidentiality of the participants

Citations:

PubMed Identifier

29080925

Citation

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.

Results Reference

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Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

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