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Moderato System in Patients With Hypertension

Primary Purpose

Hypertension, Resistant to Conventional Therapy, Atrioventricular Block

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

BackBeat Moderato System

BackBeat Moderato Sytsem

About this trial

This is an interventional treatment trial for Hypertension, Resistant to Conventional Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Requirement of dual chamber pacemaker or upgrade from a single chamber to a dual chamber pacemaker.
Stable (at least 6 weeks) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained without changes. Stable is defined as being in the same drug regimen, and the dose of each drug(s) no more than 50% reduced or 100% increased over the past 6 weeks.
Average 24-hour ambulatory systolic blood pressure ≥ 130 mmHg (with directly observed medical therapy, DOT) and office blood pressure ≥140 mmHg.
Subject is able to comply with study visits for at least 13 months (e.g., is capable and willing to travel to/from the center for all scheduled study visits).

Exclusion Criteria:

Known secondary cause of HTN.
Average ambulatory or office systolic BP > 195 mmHg.
Permanent atrial fibrillation.
History of significant paroxysmal atrial fibrillation/flutter burden (defined as >25% of beats).
Cardiac ejection fraction <50%.
Symptoms of heart failure, NYHA Class II or greater.
Hypertrophic cardiomyopathy, restrictive cardiomyopathy or inter-ventricular septal thickness ≥ 15 mm.
Subject is on dialysis.
Subject has an estimated Glomerular Filtration Rate < 30 ml/min/1.73 m²
Prior neurological events (stroke or TIA) within the past year or events at a prior time that has resulted in residual neurologic deficit.
Carotid artery disease.
Known autonomic dysfunction.
History of clinically significant untreated ventricular tachyarrhythmia or has experienced cardiac arrest.
Previous active device-based treatment for HTN.
Existing implant, other than a pacemaker that needs replacing.
Subject is or has the possibility of becoming pregnant and is unwilling of contraception during the study.
Subject is unwilling or cannot provide Informed Consent

Sites / Locations

UZ Brussel - Heart Rhythm Management Center
Vilnius University Hospital Santariskiu Klinikos
Samodzielnym Publicznym Centralnym Szpitalem Klinicznym
Silesian Center for Heart Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BackBeat Moderato System (PHC ON)

BackBeat Moderato System (PHC OFF)

Arm Description

Eligible patients randomized after optimization phase to PHC ON (PHC algorithm active) for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.

Eligible patients randomized after optimization phase to pacemaker only (PHC OFF or PHC algorithm not active) for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.

Outcomes

Primary Outcome Measures

Rate of composite of major cardiac events

including heart failure, clinically significant arrhythmias eg, persistent or increased atrial fibrillation, serious ventricular arrhythmias, myocardial infarction, stroke, heart failure, renal failure and/or related safety events that result in death

Change in average 24 hour systolic ambulatory blood pressure

Secondary Outcome Measures

Full Information

NCT ID

NCT03757377

First Posted

November 21, 2018

Last Updated

December 12, 2022

Sponsor

BackBeat Medical Inc

Collaborators

Massachusetts General Hospital, MLM Medical Labs GmbH, nabios GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03757377

Brief Title

Moderato System in Patients With Hypertension

Official Title

Clinical Evaluation of Safety and Effectiveness of the BackBeat Medical Moderato System in Patients With Hypertension: A Double-Blind Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 30, 2017 (Actual)

Primary Completion Date

February 1, 2021 (Actual)

Study Completion Date

March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BackBeat Medical Inc

Collaborators

Massachusetts General Hospital, MLM Medical Labs GmbH, nabios GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this double blind randomized study is the evaluation of the safety and efficacy of the Moderato System. The Moderato implantable pulse generator is indicated for patients who have hypertension and also require a dual chamber pacemaker in order to reduce their blood pressure. In this amended CS-03 protocol Version 3.0, the study will evaluate the safety and efficacy in a randomized, double-blind study following active treatment vs. a control patient population for a period of 3 month for efficacy and 12 months for safety (In comparison to 6 months for patients under protocol CS-03 Ver 1.1, NCT02837445). The device will be considered to have a clinical effectiveness with regard to its anti-hypertension function if there is a statistically significant and clinically meaningful reduction in mean 24-hour ambulatory systolic blood pressure in the treatment group compared to the control group. The primary efficacy endpoint will be evaluated 3 months after randomization. The Primary safety analysis will compare the treatment and the control after 12 months of treatment.

Detailed Description

Protocol CS-03 Ver 1.1 (NCT02837445) was amended at the advice of the Scientific Advisory to protocol CS-03 Version 3.0 with more stringent hypertension inclusion criteria and different observation intervals for efficacy and safety. In CS-03 Version 3.0 the time of the primary efficacy endpoint was reduced from 6 months to 3 months post randomization which was deemed a suitable interval for the chronic effect, whereas for the safety endpoint, the period was lengthened to 12 months post randomization to better monitor potential risks of the treatment on cardiac function (Blinding period was increased from 6 months to 12 months). Protocols were thus split in order to allow better clarification to the difference in the time to the primary endpoints for efficacy and safety between the two CIP versions and simplify data analysis. Protocol Ver 3.0 prescribes data analysis of all patients randomized under version 1.1 to be performed once they complete the 6 months follow-up as set in protocol version 1.1 (NCT0283744). It is expected that ~40 patients will be randomized according to protocol version 1.1 prior to the enrollment of patients according to protocol version 3.0. The results will be considered as interim analysis. The recruitment for the protocol version 1.1 is now completed. Total of 47 patients were randomized according to protocol version 1.1 and all patients completed the follow-up period for the primary endpoint. Patients are currently being followed up for the study "extension period".

6. Conditions and Keywords

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

Hypertension, Resistant to Conventional Therapy, Atrioventricular Block

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double (Participant, Investigator)

Allocation

Randomized

Enrollment

203 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BackBeat Moderato System (PHC ON)

Arm Type

Active Comparator

Arm Description

Arm Title

BackBeat Moderato System (PHC OFF)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

BackBeat Moderato System

Intervention Description

Eligible patients randomized after optimization phase to PHC ON for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator

Intervention Type

Device

Intervention Name(s)

BackBeat Moderato Sytsem

Intervention Description

Eligible patients randomized after optimization phase to PHC OFF for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.

Primary Outcome Measure Information:

Title

Rate of composite of major cardiac events

Description

Time Frame

12 months post Randomization

Title

Change in average 24 hour systolic ambulatory blood pressure

Time Frame

Week 3 pre Randomization and 3 months post Randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Requirement of dual chamber pacemaker or upgrade from a single chamber to a dual chamber pacemaker. Stable (at least 6 weeks) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained without changes. Stable is defined as being in the same drug regimen, and the dose of each drug(s) no more than 50% reduced or 100% increased over the past 6 weeks. Average 24-hour ambulatory systolic blood pressure ≥ 130 mmHg (with directly observed medical therapy, DOT) and office blood pressure ≥140 mmHg. Subject is able to comply with study visits for at least 13 months (e.g., is capable and willing to travel to/from the center for all scheduled study visits). Exclusion Criteria: Known secondary cause of HTN. Average ambulatory or office systolic BP > 195 mmHg. Permanent atrial fibrillation. History of significant paroxysmal atrial fibrillation/flutter burden (defined as >25% of beats). Cardiac ejection fraction <50%. Symptoms of heart failure, NYHA Class II or greater. Hypertrophic cardiomyopathy, restrictive cardiomyopathy or inter-ventricular septal thickness ≥ 15 mm. Subject is on dialysis. Subject has an estimated Glomerular Filtration Rate < 30 ml/min/1.73 m² Prior neurological events (stroke or TIA) within the past year or events at a prior time that has resulted in residual neurologic deficit. Carotid artery disease. Known autonomic dysfunction. History of clinically significant untreated ventricular tachyarrhythmia or has experienced cardiac arrest. Previous active device-based treatment for HTN. Existing implant, other than a pacemaker that needs replacing. Subject is or has the possibility of becoming pregnant and is unwilling of contraception during the study. Subject is unwilling or cannot provide Informed Consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karl-Heinz Kuck, Prof. MD

Organizational Affiliation

Asklepios Klinik St. Georg

Official's Role

Principal Investigator

Facility Information:

Facility Name

UZ Brussel - Heart Rhythm Management Center

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Vilnius University Hospital Santariskiu Klinikos

City

Vilnius

ZIP/Postal Code

08661

Country

Lithuania

Facility Name

Samodzielnym Publicznym Centralnym Szpitalem Klinicznym

City

Warsaw

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Silesian Center for Heart Diseases

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

12. IPD Sharing Statement

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/?term=29628351

Description

Rationale and evidence for the development of a durable device-based cardiac neuromodulation therapy for hypertension.

URL

https://www.ncbi.nlm.nih.gov/pubmed/?term=29275370

Description

Pacemaker-Mediated Programmable Hypertension Control Therapy.

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Moderato System in Patients With Hypertension

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