NCT02837445

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
7 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

July 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

3.1 years

First QC Date

July 8, 2016

Last Update Submit

December 12, 2022

Conditions

Hypertension Resistant to Conventional TherapyBradycardiaAtrioventricular Block

Outcome Measures

Primary Outcomes (2)

  • 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

    6 months post Randomization

  • Change in average 24 hour systolic ambulatory blood pressure

    Week 3 pre Randomization and 6 months post Randomization

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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

Device: PHC ON

Control

PLACEBO COMPARATOR

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

Device: PHC OFF

Interventions

PHC ONDEVICE

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

Treatment
PHC OFFDEVICE

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Krankenhaus der Elisabethinen

Linz, 4020, Austria

Location

Medical University Vienna

Vienna, 1090, Austria

Location

UZ Brussel - Heart Rhythm Management Center

Brussels, 1090, Belgium

Location

Na Homolce Hospital

Prague, 15030, Czechia

Location

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

Location

P. Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08661, Lithuania

Location

Medical University of Gdansk

Gdansk, 80-952, Poland

Location

Szpital Kliniczny Przemiemienia Panskiego

Poznan, 61-848, Poland

Location

Pomeranian Medical University Hospital no. 2

Szczecin, 70-111, Poland

Location

Samodzielnym Publicznym Centralnym Szpitalem Klinicznym

Warsaw, 02-097, Poland

Location

Silesian Center for Heart Diseases

Zabrze, 41-800, Poland

Location

Related Publications (2)

  • Chovanec M, Merkely B, Sokal A, Petru J, Kralovec S, Drtina T, Mudroch M, Geller L, Osztheimer I, Morawski S, Mika YH, Fischer A, Evans SJ, Aviv R, Rosenthal N, Burkhoff D, Kuck KH, Neuzil P. Pressure-Volume Analysis Demonstrates Short- and Long-Term Hemodynamic Effects of Atrioventricular Interval Modulation Therapy in Hypertension. JACC Clin Electrophysiol. 2025 Nov;11(11):2493-2504. doi: 10.1016/j.jacep.2025.06.017. Epub 2025 Aug 13.

    PMID: 40801869DERIVED

  • 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.

    PMID: 34387126DERIVED

MeSH Terms

Conditions

Hypertension Resistant to Conventional TherapyBradycardiaAtrioventricular Block

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart BlockCardiac Conduction System Disease

Study Officials

  • Karl-Heinz Kuck, Prof. MD

    Asklepios Klinik St. Georg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 19, 2016

Study Start

July 12, 2016

Primary Completion

August 1, 2019

Study Completion

March 1, 2023

Last Updated

December 14, 2022

Record last verified: 2022-12

Locations

LA(1)PL(5)HU(1)AU(2)BE(1)CZ(1)LI(1)