Health TrialsbyHealthPanel

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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImpulse Dynamics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥18 years) diagnosed with symptomatic heart failure

Patients with Heart failure with reduced Ejection Fraction (HFrEF) where the Ejection Fraction (EF) is ≤40%

CRT device has been implanted >1 year

Patients are functional class NYHA III-IV

Disqualifiers

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

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Time frame
6 month

Secondary outcomes

1

Change in loop diuretic dose

Change in loop diuretic dose from baseline to 6-month follow-up.

Time frame
6-month
2

Change in eGFR

Change in eGFR from baseline to 6-month follow-up

Time frame
6-month
3

Change in SBP

Change in SBP from baseline to 6-month follow-up.

Time frame
6-month
4

Adverse events (AEs) associated with CCM therapy.

Adverse events (AEs) associated with CCM therapy.

Time frame
12-month

Other outcomes

Sponsors and contacts

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Impulse Dynamics

Lead sponsor

Source ClinicalTrials.gov
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