CCM in Heart Failure With Preserved Ejection Fraction

Not Applicable

Completed

• Conditions: Heart Failure, Diastolic

• Registration Number: NCT03240237
• Lead Sponsor: Impulse Dynamics

Brief Summary

This pilot study will evaluate the efficacy and safety of CCM therapy in heart failure patients with baseline EF≥50% (HFpEF) who have New York Heart Association (NYHA) Class II or III symptoms despite appropriate medication.

The terminology of the HF classification HFpEF is based on the 2016 European Society of Cardiology (ESC) Heart Failure Guidelines.

Detailed Description

This is a pilot clinical study of CCM in addition to optimal medical therapy (OMT) over a 24 week period.The primary endpoint shall be mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score (reflecting integrated information on physical limitations, symptoms, self-efficacy, social interference and quality of life).

This pilot study will collect efficacy and safety data in heart failure patients having NYHA class II and III symptoms despite appropriate medication with baseline ejection fraction equal or greater than 50% (HFpEF populations).

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Study Start: 2018-05-01
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
KCCQ change	24 weeks	Mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score

Secondary Outcome Measures

Name	Time	Method
NT-proBNP	24 weeks	Mean Change in 24 weeks
NYHA class	24 weeks	Mean Change in 24 weeks
Echocardiography	24 weeks	LAVi and diastolic function: septal E' velocity, septal E/E' ratio

Trial Locations

Locations (17)

Friendly Society Private Hospital; 🇦🇺 Bundaberg, Queensland, Australia

St. John of God Bunbury; 🇦🇺 Bunbury, Australia

St. John of God Murdoch Hospital; 🇦🇺 Perth, Australia

Hospital Na Homolce; 🇨🇿 Praha 5, Czechia

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Hesse, Germany

INRCA IRCCS Ancona; 🇮🇹 Ancona, Rome, Italy

Auxologico Institute; 🇮🇹 Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego zakład leczniczy Centralnego Szpitala Klinicznego; 🇵🇱 Warsaw, Poland

4 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ we Wroclawiu; 🇵🇱 Wroclaw, Poland

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