Hypertension (HTN)NCT07598760
Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction
A study testing Moderato Plus device with Cardiac Neuromodulation Therapy in people with Hypertension (HTN) and Heart Failure With Preserved Ejection Fraction (HFpEF, run by BackBeat Medical Inc at 2 sites in Georgia.
Trial summary
This is an open-label pilot study to evaluate the feasibility of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who require dual-chamber pacemaker implantation or replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN), Heart Failure With Preserved Ejection Fraction (HFpEF, Hypertension, Systolic
- What is being tested?
- Moderato Plus device with Cardiac Neuromodulation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGeorgia
- Study dates
- 30 May 2026to 30 Nov 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Clinical indication for dual-chamber pacemaker implantation or replacement
- Diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as left ventricular ejection fraction ≥50%
- History of hypertension
- NYHA functional class II or III
- On stable guideline-directed medical therapy
- Able and willing to provide written informed consent
Who cannot join
- NYHA class IV heart failure
- Permanent or persistent atrial fibrillation
- Recent acute decompensated heart failure
- Significant valvular heart disease requiring intervention
- Severe comorbid conditions that, in the investigator's judgment, would make study participation unsafe
- Pregnant or breastfeeding individuals
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Georgia2 sites
Georgian Medical Research Clinic Healthycore
Tbilisi
Tbilisi Heart and Vascular Clinic
Tbilisi
About this study
Official title: Clinical Feasibility of Cardiac Neuromodulation Therapy (CNT) as Treatment for HFpEF
This is an open-label pilot study to evaluate the feasibility of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who require dual-chamber pacemaker implantation or replacement. The study will assess blood pressure and heart function at rest and during exercise, with and without CNT, for up to 12 months. Participants will receive the Moderato Plus device and complete scheduled follow-up visits. After study completion, CNT therapy will be discontinued and participants will return to standard medical care.
Read the detailed description
This study is a pilot, open-label, non-randomized feasibility investigation of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who are indicated for dual-chamber pacemaker implantation or replacement. The purpose of the study is to assess the feasibility of applying CNT and to evaluate its effects on blood pressure, heart failure status, and cardiac function at rest and during exercise over a follow-up period of up to 12 months. Eligible participants who provide informed consent and meet all inclusion and exclusion criteria will receive implantation of the Moderato Plus device. Following implantation, participants will complete scheduled study visits including two baseline visits and follow-up visits at approximately 3, 6, and 12 months. Study assessments may include blood pressure measurements, New York Heart Association (NYHA) functional class, echocardiographic evaluations, laboratory biomarkers, functional exercise testing, and patient-reported outcome questionnaires. At selected visits, cardiac performance during rest and standardized exercise conditions will be assessed to compare responses with CNT therapy activated and deactivated according to a predefined protocol. These comparisons are intended to evaluate short-term physiological responses to CNT and support feasibility assessments.
The first group of enrolled participants will undergo initial study assessments prior to long-term CNT activation to confirm the feasibility and appropriateness of the evaluation procedures. Based on this review, the study will continue as planned. Upon completion of the study follow-up, CNT therapy will be discontinued, and participants will resume standard clinical care.
- Conditions
- Hypertension (HTN), Heart Failure With Preserved Ejection Fraction (HFpEF, Hypertension, Systolic
- Being tested
- Moderato Plus device with Cardiac Neuromodulation Therapy
- Keywords
- CNT, HFpEF, Hypertension
- Medical subject headings
- Hypertension, Isolated Systolic Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderato Plus device with Cardiac Neuromodulation TherapyDevice
Moderato Plus System with CNT
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Neuromodulation Therapy | Experimental | Participants receive the Moderato Plus device with Cardiac Neuromodulation Therapy Receives: Device: Moderato Plus device with Cardiac Neuromodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardiac Output During Supine Exercise
Cardiac output measured during supine rest and graded supine bicycle exercise using thermodilution techniques, with CNT activated and deactivated, at baseline and at 6 months. Results will be summarized as the change in cardiac output during exercise between baseline and follow-up.
Measured: 6-months
Secondary outcomes (7)
Change in 24-Hour Ambulatory Systolic Blood Pressure
Change in average 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM), comparing baseline and the 3-month visit.
Measured: 3 months
Change in Daytime and Nighttime Ambulatory Systolic Blood Pressure
Change in average daytime and nighttime systolic blood pressure measured by 24-hour ambulatory blood pressure monitoring (ABPM), comparing baseline and the 3-month visit.
Measured: 3-months
Change in Office Blood Pressure Measurements
Change in office-based systolic and diastolic blood pressure measurements at each study visit compared to baseline.
Measured: through study end, an average of 1 year
Change in NYHA Functional Class
Change in New York Heart Association (NYHA) functional classification assessed at Visits 4 (3 months) and 6 (12 months) compared with baseline.
Measured: at 3 months and 12 months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score Overall Summary Score
Change in patient-reported health status as measured by the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Overall Summary Score, comparing follow-up assessments with baseline values. The KCCQ-23 is a validated, disease-specific instrument consisting of 23 items, with scores ranging from 0 to 100, where higher scores indicate better health status (fewer symptoms and physical and social limitations).
Measured: Baseline through study end, an average of 1 year
Change in Six-Minute Walk Distance
Change in functional exercise capacity as measured by the six-minute walk test, comparing follow-up assessments with baseline.
Measured: Baseline through study end
Change in NT-proBNP Levels
Change in plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels measured at follow-up compared with baseline.
Measured: Baseline through study end, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start30 May 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BackBeat Medical Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598760
- Sponsor's protocol ID
- CS-11
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No