Heart FailureNCT06580392
CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)
An observational study of Heart Failure, run by Impulse Dynamics at 2 sites in Italy.
Trial summary
The primary objective of this study is to evaluate the impact of Cardiac Contractility Modulation (CCM) therapy on the initiation and up-titration of Guideline-Directed Medical Therapy (GDMT) in patients with heart failure (HF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Feb 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Subject selection will be based on specific inclusion and exclusion criteria.
Who may be able to join
- Adults (≥18 years) diagnosed with symptomatic heart failure
- Patients with Heart failure with reduced Ejection Fraction (HFrEF) where the Ejection Fraction (EF) is ≤40%
- Historical LVEF assessed up to 6 months prior to consent by any modality can be used if available
- Patients can have an active concomitant CRT device already - implanted provided the following criteria:
- CRT device has been implanted >1 year
- Patients are functional class NYHA III-IV
Who cannot join
- Patients that are unlikely to adhere to medical therapy for reasons other than intolerance or contraindications.
- Patients with a QMS score >5
- eGFR <15
- Patients with a concomitant CRT device that has already been implanted and deemed to be a responder
- Patients with class I indication for a concomitant CRT device
- Patients with significant comorbidities or conditions that may interfere with the study assessments
- Patients with contraindications to CCM therapy or unable to undergo implantation
- Severe stenotic valve disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
AO dei Colli - O.Monaldi
Naples
Daniele Masarone Dr., 081 706 1111, monaldi@ospedalideicolli.it
- Recruiting
Gemelli University Hospital
Rome, Italy
Nadia Aspromonte, MD, nadia.aspromonte@policlinicogemelli.it
About this study
Official title: Cardiac Contractility Modulation (CCM) and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure
The primary objective of this study is to evaluate the impact of Cardiac Contractility Modulation (CCM) therapy on the initiation and up-titration of Guideline-Directed Medical Therapy (GDMT) in patients with heart failure (HF). This will be assessed by the change in Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month following post-CCM device implant.
Read the detailed description
Design Prospective, non-randomized, comparison analysis of medication use and dosing at pre/post CCM therapy. The Fix-GDMT-HF study aims to enroll up to 200 subjects (100 in Investigational Arm and up to 100 in Registry Arm). Subjects identified not eligible to participate in the investigational arm can participate in the registry arm.
Method
- Subjects with QMS ≤ 5, eGFR ≥15, diagnosed symptomatic heart failure and LVEF ≤40% will be enrolled after review and approval by a member of the steering committee. Eligible subjects will receive CCM therapy and be enrolled in the investigational arm of the study. Medication optimization(Med op#2) will be assessed after implantation(approx. 3month post implant), followed by evaluation of QMS and other endpoints at 6 and 12 months. A target of 100 patients will be enrolled in the investigational arm.
- After medical optimization (Med op# 1), if the patient has QMS > 5 or identified during SC review as not eligible to participate in investigational arm can participate in the registry arm. They will continue treatment guided by local practice (including potential CCM implant) with QMS assessment (and other data collection as patients in investigational arm) at 6- and 12-month visit. The registry arm will be restricted to 100 patients.
Endpoints
Primary Endpoint:
- Change in the Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month follow-up (post-CCM) of the Optimizer device implant.
Secondary Endpoints:
- Change in loop diuretic dose from baseline to 6-month follow-up.
- Change in eGFR from baseline to 6-month follow-up.
- Change in SBP from baseline to 6-month follow-up.
- Adverse events (AEs) associated with CCM therapy.
- Change in HR among patients with concomitant cardiac rhythm management (CRM) devices.
- Percentage of patients achieving maximal/optimal GDMT following CCM therapy.
- GDMT adherence as measured by change in QMS score from 6 months (post-CCM) to 12 months (post-CCM).
Patients
Investigational arm - 100 subjects complete the study with 12- month of follow-up.
Registry arm - restricted to 100 subjects
Sites 10 sites in Germany \& Italy. 10 sites in the USA.
Duration
The entire study is expected to take approximately 24 months or (until the target number of subjects has been reached), including the enrolment and follow-up periods.
- Conditions
- Heart Failure
- Keywords
- Change in Quad medication score
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quad Medication Score
Change in the Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month follow-up (post-CCM) of the Optimizer device implant
Measured: 6 month
Secondary outcomes (6)
Change in loop diuretic dose
Change in loop diuretic dose from baseline to 6-month follow-up.
Measured: 6-month
Change in eGFR
Change in eGFR from baseline to 6-month follow-up
Measured: 6-month
Change in SBP
Change in SBP from baseline to 6-month follow-up.
Measured: 6-month
Adverse events (AEs) associated with CCM therapy.
Adverse events (AEs) associated with CCM therapy.
Measured: 12-month
Percentage of patients achieving maximal/optimal GDMT following CCM therapy
Percentage of patients achieving maximal/optimal GDMT following CCM therapy
Measured: 12-month
GDMT adherence as measured by change in QMS score
GDMT adherence as measured by change in QMS score from 6 months (post-CCM) to 12 months (post-CCM).
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Impulse Dynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580392
- Sponsor's protocol ID
- ID_CA_PRO_2105
- Status last verified
- Jul 2025
- First submitted
- 28 Aug 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Contractility Modulation (CCM) and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT06580392
- Acronym / sponsor ID
- ID_CA_PRO_2105
- Conditions
- Heart Failure
- Keywords
- Change in Quad medication score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Impulse DynamicsIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the impact of Cardiac Contractility Modulation (CCM) therapy on the initiation and up-titration of Guideline-Directed Medical Therapy (GDMT) in patients with heart failure (HF). This will be assessed by the change in Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month following post-CCM device implant.
Detailed description
Design Prospective, non-randomized, comparison analysis of medication use and dosing at pre/post CCM therapy. The Fix-GDMT-HF study aims to enroll up to 200 subjects (100 in Investigational Arm and up to 100 in Registry Arm). Subjects identified not eligible to participate in the investigational arm can participate in the registry arm.
Method
- Subjects with QMS ≤ 5, eGFR ≥15, diagnosed symptomatic heart failure and LVEF ≤40% will be enrolled after review and approval by a member of the steering committee. Eligible subjects will receive CCM therapy and be enrolled in the investigational arm of the study. Medication optimization(Med op#2) will be assessed after implantation(approx. 3month post implant), followed by evaluation of QMS and other endpoints at 6 and 12 months. A target of 100 patients will be enrolled in the investigational arm.
- After medical optimization (Med op# 1), if the patient has QMS > 5 or identified during SC review as not eligible to participate in investigational arm can participate in the registry arm. They will continue treatment guided by local practice (including potential CCM implant) with QMS assessment (and other data collection as patients in investigational arm) at 6- and 12-month visit. The registry arm will be restricted to 100 patients.
Endpoints
Primary Endpoint:
- Change in the Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month follow-up (post-CCM) of the Optimizer device implant.
Secondary Endpoints:
- Change in loop diuretic dose from baseline to 6-month follow-up.
- Change in eGFR from baseline to 6-month follow-up.
- Change in SBP from baseline to 6-month follow-up.
- Adverse events (AEs) associated with CCM therapy.
- Change in HR among patients with concomitant cardiac rhythm management (CRM) devices.
- Percentage of patients achieving maximal/optimal GDMT following CCM therapy.
- GDMT adherence as measured by change in QMS score from 6 months (post-CCM) to 12 months (post-CCM).
Patients
Investigational arm - 100 subjects complete the study with 12- month of follow-up.
Registry arm - restricted to 100 subjects
Sites 10 sites in Germany \& Italy. 10 sites in the USA.
Duration
The entire study is expected to take approximately 24 months or (until the target number of subjects has been reached), including the enrolment and follow-up periods.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject selection will be based on specific inclusion and exclusion criteria.
Key inclusion criteria (6 listed)
- Adults (≥18 years) diagnosed with symptomatic heart failure
- Patients with Heart failure with reduced Ejection Fraction (HFrEF) where the Ejection Fraction (EF) is ≤40%
- Patients can have an active concomitant CRT device already - implanted provided the following criteria:
Key exclusion criteria (8 listed)
- Patients that are unlikely to adhere to medical therapy for reasons other than intolerance or contraindications.
- Patients with a QMS score >5
- eGFR <15
- Patients with a concomitant CRT device that has already been implanted and deemed to be a responder
- Patients with class I indication for a concomitant CRT device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Quad Medication Score
Time frame: 6 month
Change in the Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month follow-up (post-CCM) of the Optimizer device implant
6 secondary outcomes
Change in loop diuretic dose
Time frame: 6-month
Change in eGFR
Time frame: 6-month
Change in SBP
Time frame: 6-month
Adverse events (AEs) associated with CCM therapy.
Time frame: 12-month
Percentage of patients achieving maximal/optimal GDMT following CCM therapy
Time frame: 12-month
GDMT adherence as measured by change in QMS score
Time frame: 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Impulse Dynamics at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gary Cranke ((856) 642-9933, gcranke@impulsedynamics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quad Medication Score (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.