CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)

NCT06580392 | Recruiting

• 1 other identifier: ID_CA_PRO_2105
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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). This will be assessed by the change in Quad Medication Score (QMS) from baseline (pre-CCM) to 6-month following post-CCM device implant.

Conditions

Heart Failure

Keywords

Change in Quad medication score

Outcome Measures

Primary Outcomes (1)

• 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

  6 month

Secondary Outcomes (6)

• Change in loop diuretic dose

  6-month

• Change in eGFR

  6-month

• Change in SBP

  6-month

• Adverse events (AEs) associated with CCM therapy.

  12-month

• Percentage of patients achieving maximal/optimal GDMT following CCM therapy

  12-month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subject selection will be based on specific inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Impulse Dynamics: lead

Study Sites (2)

Gemelli University Hospital

Rome, Italy, Italy

RECRUITING

AO dei Colli - O.Monaldi

Napoli, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Gary Cranke

CONTACT

(856) 642-9933; gcranke@impulsedynamics.com

Rachael Riccitello

CONTACT

(856) 642-9933; rriccitello@impulsedynamics.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)