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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03240237




Registration number
NCT03240237
Ethics application status
Date submitted
2/08/2017
Date registered
7/08/2017

Titles & IDs
Public title
CCM in Heart Failure With Preserved Ejection Fraction
Scientific title
Cardiac Contractility Modulation Therapy in Subjects With Heart Failure With Preserved Ejection Fraction
Secondary ID [1] 0 0
ID_CP_OPT2016-012_0
Universal Trial Number (UTN)
Trial acronym
CCM-HFpEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure, Diastolic 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Optimizer SMART

Experimental: CCM therapy - Optimizer SMART


Treatment: Devices: Optimizer SMART
Cardiac Contractility Modulation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
KCCQ change
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Echocardiography
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
NT-proBNP
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
NYHA class
Timepoint [3] 0 0
24 weeks

Eligibility
Key inclusion criteria
1. Inclusion criteria

1. Baseline ejection fraction = 50% (as assessed by echocardiogram within 30 days of enrollment and confirmed by the echo core laboratory).
2. NYHA class II or III symptoms despite receiving stable optimal medical therapy (OMT) for at least 30 days based on patient's medical records (chronic stable, not transient or crescendo heart failure or angina pectoris)
3. Stable optimal medical therapy for Heart failure for 3 months.
4. NT-proBNP > 220 pg/ml for subjects in sinus rhythm or > 600 pg/ml for subjects in atrial fibrillation
5. Has the following (as assessed by the core lab):

* LAVi = 34 ml/m² or LVH >12mm AND either
* E/e' = 13 OR
* septal e' < 7 cm/s or lateral e' <10 cm/s
6. Patient giving informed consent, willing to be available for scheduled study follow-up visits, and able to complete all testing of the study protocol
2.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

1. Age below 40 or greater than 80
2. Patients with expected lifespan of less than 12 months from time of enrollment
3. Subjects referred to an institution based on a judicial or administrative order
4. Dilated left ventricle, as evidenced by LVEDVI >= 97 mL/m2 (as assessed by the echo core lab)
5. Primary cardiac valvular disease (anything more than grade 2)
6. Congenital or untreated ischemic heart disease
7. Infiltrative / inflammatory / genetic cardiomyopathy as documented in the medical record (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, M. Fabry, cardiac tumor), or persistent large pericardial effusion
8. Unstable or frequent (>1 episode/week) angina pectoris
9. Hospitalization for HF requiring the use of inotropic support or IABP within 30 days of enrollment
10. Systolic Blood Pressure > 160 mmHg
11. Uncorrected severe anemia (e.g. hemoglobin <9g/dL)
12. PR interval greater than 375 ms
13. Exercise tolerance limited due to noncardiac disorders (e.g. deconditioning, severe lung disease, frailty)
14. Scheduled for a cardiac surgery or a PCI procedure, or had a cardiac surgery procedure within 90 days or a PCI procedure within 30 days prior to enrollment
15. Myocardial infarction within 90 days of enrollment
16. Cardioversion within 30 days of enrollment
17. History of significant ectopy either on 12-lead ECG or Holter monitoring (more than 10% PVCs).
18. Heart rate > 110 bpm on ECG for patients with atrial fibrillation
19. Mechanical tricuspid valve
20. Prior heart transplant or ventricular assist device
21. Pregnant or planning to become pregnant during the study
22. Breastfeeding subjects
23. Subject participating in another medical therapy or device related study, unrelated to CCM™, at the same time or within 30 days prior to enrollment into this study
24. Subjects on dialysis, or with documented GFR<30 or with other major medical disorder (e.g. severe anemia, liver failure)
25. Subjects with any active non-cardiac implants

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/07/2023
Sample size
Target
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Friendly Society Private Hospital - Bundaberg
Recruitment hospital [2] 0 0
St. John of God Bunbury - Bunbury
Recruitment hospital [3] 0 0
St. John of God Murdoch Hospital - Perth
Recruitment postcode(s) [1] 0 0
4670 - Bundaberg
Recruitment postcode(s) [2] 0 0
6150 - Bunbury
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Praha 5
Country [2] 0 0
Germany
State/province [2] 0 0
Hesse
Country [3] 0 0
Italy
State/province [3] 0 0
Rome
Country [4] 0 0
Italy
State/province [4] 0 0
Milan
Country [5] 0 0
Poland
State/province [5] 0 0
Warsaw
Country [6] 0 0
Poland
State/province [6] 0 0
Wroclaw
Country [7] 0 0
Portugal
State/province [7] 0 0
Lisbon
Country [8] 0 0
Spain
State/province [8] 0 0
C/ A Choupana S.n
Country [9] 0 0
Spain
State/province [9] 0 0
Alicante
Country [10] 0 0
Spain
State/province [10] 0 0
Madrid
Country [11] 0 0
Spain
State/province [11] 0 0
Vigo
Country [12] 0 0
Sweden
State/province [12] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Impulse Dynamics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carsten Tschoepe, Prof.
Address 0 0
University Hospital Charite Berlin
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Linde C, Grabowski M, Ponikowski P, Rao I, Stagg A... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT03240237