Moderato System: A Double-Blind Randomized Trial Ver 1.1
Primary Purpose
Hypertension Resistant to Conventional Therapy, Bradycardia, Atrioventricular Block
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PHC ON
PHC OFF
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension Resistant to Conventional Therapy
Eligibility Criteria
Inclusion Criteria:
- Subject requires an implant or replacement a of dual chamber pacemaker
- Stable (at least one month) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained for 7 months.
- Average day time (7AM-10PM) ambulatory systolic blood pressure ≥ 130 mmHg and office blood pressure ≥140 mmHg.
- Subject lives in the proximity of the study center, which permits compliance with study visits for at least 7 months.
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 sudden death.
- 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
- Krankenhaus der Elisabethinen
- Medical University Vienna
- UZ Brussel - Heart Rhythm Management Center
- Na Homolce Hospital
- Semmelweis University Heart and Vascular Center
- P. Stradins Clinical University Hospital
- Vilnius University Hospital Santariskiu Klinikos
- Medical University of Gdansk
- Szpital Kliniczny Przemiemienia Panskiego
- Pomeranian Medical University Hospital no. 2
- 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
Treatment
Control
Arm Description
Eligible patients randomized after optimization phase to PHC ON for 6 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) for 6 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
NCT02837445
First Posted
July 8, 2016
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
NCT02837445
Brief Title
Moderato System: A Double-Blind Randomized Trial Ver 1.1
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
July 12, 2016 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
March 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
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.
The primary objectives of this study are to provide evidence of safety and clinical efficacy of the anti-hypertensive effects of the Moderato System. This will be accomplished by evaluating changes in blood pressure in an active treatment vs. a control patient population for a period of 6 months.
The device will be considered to have a clinical effectiveness with regard to its anti-hypertension functions 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.
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 from 6 month to 12 months post randomization to better monitor potential risks of the treatment on cardiac function (Blinding period was increased from 6 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, Bradycardia, Atrioventricular Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Eligible patients randomized after optimization phase to PHC ON for 6 months Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Eligible patients randomized after optimization phase to pacemaker only (PHC OFF) for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
Intervention Type
Device
Intervention Name(s)
PHC ON
Intervention Description
Eligible patients randomized after optimization phase to PHC ON for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
Intervention Type
Device
Intervention Name(s)
PHC OFF
Intervention Description
Eligible patients randomized after optimization phase to PHC OFF for 6 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
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
Time Frame
6 months post Randomization
Title
Change in average 24 hour systolic ambulatory blood pressure
Time Frame
Week 3 pre Randomization and 6 months post Randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject requires an implant or replacement a of dual chamber pacemaker
Stable (at least one month) hypertension treatment with at least 1 anti-hypertensive drug, which is anticipated to be maintained for 7 months.
Average day time (7AM-10PM) ambulatory systolic blood pressure ≥ 130 mmHg and office blood pressure ≥140 mmHg.
Subject lives in the proximity of the study center, which permits compliance with study visits for at least 7 months.
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 sudden death.
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
Krankenhaus der Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
UZ Brussel - Heart Rhythm Management Center
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
15030
Country
Czechia
Facility Name
Semmelweis University Heart and Vascular Center
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
P. Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Medical University of Gdansk
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Szpital Kliniczny Przemiemienia Panskiego
City
Poznań
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Pomeranian Medical University Hospital no. 2
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
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
Citations:
PubMed Identifier
34387126
Citation
Kalarus Z, Merkely B, Neuzil P, Grabowski M, Mitkowski P, Marinskis G, Erglis A, Kazmierczak J, Sturmberger T, Sokal A, Pluta S, Geller L, Osztheimer I, Malek F, Kolodzinska A, Mika Y, Evans SJ, Hastings HM, Burkhoff D, Kuck KH. Pacemaker-Based Cardiac Neuromodulation Therapy in Patients With Hypertension: A Pilot Study. J Am Heart Assoc. 2021 Aug 17;10(16):e020492. doi: 10.1161/JAHA.120.020492. Epub 2021 Aug 13.
Results Reference
derived
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Moderato System: A Double-Blind Randomized Trial Ver 1.1
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