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Congenital Heart DefectsPhase 2/3CARE-CHDNCT00450684

Cardiac Resynchronization Therapy in Congenital Heart Defects

A Phase 2/3 study testing Implantation and testing of CRT in people with Congenital Heart Defects, run by Competence Network for Congenital Heart Defects at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this multicentre prospective therapeutic study is to evaluate the effects of CRT on the right and left ventricular function of patients with CHD in the medium and long term. Read more about this study

Who is it for?
Any age
Conditions the study is for
Congenital Heart Defects
What is being tested?
Implantation and testing of CRT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
16 sitesin 2 countries
Study dates
May 2007to Sep 2013
Phase
Phase 2/3
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with congenital heart defects
  • Heart failure of the Morphologically right or left system ventricle with an absolute ejection fraction of < 40% in the failed ventricle
  • NYHA classes II-IV
  • Optimal drug therapy for heart failure according to the ESC guidelines
  • QRS interval ≥ 120 ms (demonstrated in at least two relevant ECG derivations, depending on existing bundle branch block symptoms)
  • Patients with chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above-mentioned criteria
  • Patients with morphologically right ventricle in system position and significant insufficiency of the systemic atrioventricular valve, if they also meet the criteria listed above

Who cannot join

  • PTCA, cardiomyoplasty or myocardial infarction / unstable angina pectoris or cerebral insult within the 6 weeks preceding the planned cardiac resynchronisation therapy
  • Patients with pulmonary hypertension / Eisenmenger's syndrome
  • Life expectancy < 1 year due to a non-cardiac disease
  • Anticipated poor compliance by the patient
  • Pregnancy and breastfeeding
  • Known or persistent abuse of prescription medicines, recreational drugs or alcohol

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

Germany15 sites

  • Uniklinik RWTH Aachen, AÖR, Klinik für Kinderkardiologie

    Aachen, D-52074

  • Herz- und Diabeteszentrum NRW, Klinik für Kinderkardiologie und angeborene Herzfehler

    Bad Oeynhausen, D-32545

  • Charité - Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Kardiologie

    Berlin, D-13353

  • Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler/Kinderkardiologie

    Berlin, D-13353

  • Elektrophysiologie Bremen und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie

    Bremen, D-28227

  • Universitätsklinikum Erlangen, Kinderkardiologische Abteilung

    Erlangen, D-91054

  • Universitäts-Herzzentrum Freiburg Bad Krozingen, Zentrum für Kinder- und Jugendmedizin, Angeborene Herzfehler/Pädiatrische Kardiologie

    Freiburg im Breisgau, D-79106

  • Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Pädiatrische Kardiologie

    Halle, Saxony-Anhalt, D-06120

  • Universitäres Herzzentrum Hamburg, Kinderkardiologie

    Hamburg, D-20246

  • Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie

    Homburg/Saar, D-66421

  • Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler

    München, D-80336

  • Universitätsklinikum Münster, Klinik für angeborene (EMAH) und erworbene Herzfehler

    Münster, North Rhine-Westphalia, D-48149

  • Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie

    Münster, D-48149

  • Deutsches Kinderherzzentrum Sankt Augustin, Abt. Kardiologie/Angeborene Herzfehler

    Sankt Augustin, D-53757

  • Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Abt. Kinderkardiologie, Pulmologie, Intensivmedizin

    Tübingen, D-72076

Other trials in Germany

Austria1 site

  • AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie

    Vienna, A-1090

Other trials in Austria

About this study

Official title: Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects

The objective of this multicentre prospective therapeutic study is to evaluate the effects of CRT on the right and left ventricular function of patients with CHD in the medium and long term. Patients who reject the randomization or cannot be paced with right ventricular pacing alone will be enrolled in group C with continuous biventricular pacing, which is the main group in this study. Optional: Immediately after implantation the patients are divided into group A and B (randomized, single blind (for the patient), cross-over design).

The treatment and the completing follow-up examination will take approximately 18 months and includes seven visits - one previous to the CRT and six at certain times afterward. At selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the global and regional ventricular function are performed. Subjective quality of life assessment (questionnaire) will also be performed at the defined follow-up intervals, and if applicable (optional) also objective assessment of the physical performance (VO2 max).

55 patients also including children and adults with CHD are planned to be included in the study. The main target is to provide evidence of the effectiveness of CRT with biventricular stimulation in terms of improved ventricular function (ejection fraction and QRS interval).

Being tested
Implantation and testing of CRT
Medical subject headings
Heart Defects, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantation and testing of CRTDevice

    Biventricular pacing for 12 weeks (CRT ON) followed by automatic rhythmicity or the original, conventional biventricular stimulation for 12 weeks (CRT OFF), then returning to biventricular pacing (CRT ON).

  • Implantation and testing of CRTDevice

    Automatic rhythmicity or original conventional biventricular stimulation for 12 weeks (CRT OFF) followed by biventricular pacing (CRT ON).

Study groups in NCT00450684
Study groupRoleWhat they receive
Group AExperimentalImplantation and testing of CRT
Receives: Device: Implantation and testing of CRT
Group BExperimentalIImplantation and testing of CRT
Receives: Device: Implantation and testing of CRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ejection fraction

    Measured: 7 visits

  2. QRS-interval

    Measured: 7 visits

Secondary outcomes (11)

  1. Echocardiographic standard parameters (e.g. LVIDd. FS, RVIDd)

    Measured: 7 visits

  2. Tissue Doppler echocardiography: dyssynchrony parameters, regional myocardiac function

    Measured: 7 visits

  3. 3D echocardiography:LV volumes, LVEF, Dyssynchrony index

    Measured: 7 visits

  4. NT pro-BNP

    Measured: 7 visits

  5. Spiroergometry: performance P (W/kg), incl. VO2,max

    Measured: 6 visits

  6. Walking distance in 6 minutes

    Measured: 6 visits

  7. Decrease of hospitalization

    Measured: 18 months

  8. Decrease of ventricular and atrial arrhythmias

    Measured: 18 months

  9. Prevention or postponement of heart transplantation

    Measured: 18 Months

  10. Quality of life

    Measured: 6 visits

  11. death

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionFeb 2012
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00450684
Sponsor's protocol ID
CARE-CHD
Acronym
CARE-CHD
Status last verified
Oct 2014
First submitted
21 Mar 2007
Last updated
10 Oct 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Implantation and testing of CRT in people with Congenital Heart Defects, run by Competence Network for Congenital Heart Defects at 16 sites in 2 countries.

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 7 inclusion and 6 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: finished, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Germany, Austria. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ejection fraction (time frame: 7 visits). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00450684.

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 10 Oct 2014.

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