AzTrials
AzTrials

Heart FailurePhase 2NCT00461019

CardioFit™ for the Treatment of Heart Failure

A Phase 2 study testing Implantation and activation of the vagus nerve stimulator in people with Heart Failure, run by BioControl Medical at 6 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

Congestive Heart Failure is the result of a number of diseases affecting the heart, causing the heart's failure to properly meet the body demands for blood circulation. In spite of advances in drug therapy, it remains a significant public health problem. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Heart Failure
What is being tested?
Implantation and activation of the vagus nerve stimulator
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
6 sitesin 4 countries
Study dates
Feb 2007to Feb 2010
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is in chronic heart failure, NYHA II-III. The patient may have been previously in class IV but must be in class II or III for three or more months prior to study entry;
  • Age between 18 and 75 years;
  • The patient is a male or postmenopausal female. Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used;
  • Patient must sign an approved informed consent form. Patient agrees to attend all follow-up evaluations;
  • Patient should be in sinus rhythm. Average 24-hour heart rate is between 60 and 110 b/min in a recorded 24-h Holter measurement;
  • Patient should be in optimal medical treatment with no change in treatment in the previous 3 months with the exception of diuretics;
  • Left ventricular ejection fraction estimated by echocardiography, cardiac angiography, radionuclide study, or other accepted mode of evaluation, is no more than 35%;
  • Patient is physically capable and willing to perform repeated physically demanding tests associated with the study.

Who cannot join

  • Presence of an immediately life threatening condition or disease other than heart failure, such as cancer, terminal renal failure etc.
  • Acute myocardial Infarction (MI), variant angina pectoris, unstable angina or acute coronary syndrome in the previous three months;
  • Previous stroke;
  • Coronary Artery Bypass Surgery (CABG) or Percutaneous Coronary Intervention in the past 3 months;
  • Episode of NYHA class IV heart failure, including acute pulmonary oedema in the previous three months;
  • Heart failure due to acute myocarditis. Restrictive or constrictive pericarditis, haemodynamically significant aortic valve insufficiency aortic stenosis, or mitral valve stenosis;
Show all 26Show fewer
  • Severe renal or hepatic failure (Creatinine level>3 mg% (265 micromole/liter) or transaminase level four times ULN);
  • Diabetes Mellitus treated with insulin for more than two years prior to study entry;
  • Diabetic neuropathy;
  • Previous neck surgery, including for Peripheral Vascular Disease (PVD), malignancy, and previous irradiation therapy of the neck;
  • Current hypotension (systolic blood pressure below 80 mmHg);
  • Active peptic disease or history of upper GI bleeding;
  • Asthma, severe COPD (e.g. FEV1<1.5 liter), or severe restrictive lung disease;
  • 1st degree AV block with PR interval > 240msec, 2nd or 3rd degree AV block;
  • Atrial fibrillation or flutter in the in the previous 3 months;
  • Sustained ventricular tachyarrhythmia with hemodynamic compromise, in the absence of implanted ICD;
  • Long QT syndrome, congenital or acquired;
  • Recorded or suspected symptomatic vaso-vagal response;
  • Treatment by investigational drug or device within the past 3 months;
  • Glaucoma, or history of glaucoma;
  • Major psychiatric disorder in the present or in the past; Dementia;
  • Patients transplanted with tissues or organs;
  • Immunosuppressed patients; patients under systemic steroid treatment;
  • Anemia with Hb<10gr/L, unless treated with Epo;
  • Patients who are at risk for carotid arteries plaques and have unstable carotid plaques, as assessed by Echo Doppler; and/or patients with >70% carotid artery stenosis;
  • Patient is candidate for cardiac resynchronization device implantation.

Trial locations and contacts

6 sites in 4 countries.

6 sites in 4 countries

Germany3 sites

  • Georg-August-Universität Göttingen

    Göttingen, 37075

  • Otto von-Guericke University Clinik

    Magdeburg, 39120

  • I. Medizinische Klinik, Klinikum Mannheim GmbH Universitätsklinikum Fakultät für klinische Medizin Mannheim der Universität Heidelberg

    Mannheim, 68167

Other trials in Germany

Italy1 site

  • Fondazione IRCCS Policlinico "San Matteo"

    Pavia, Pavia, 27100

Other trials in Italy

Netherlands1 site

  • Academic Hospital Maastricht

    Maastricht, 6202 AZ

Other trials in Netherlands

Serbia1 site

  • Pacemaker center, Cardiovascular institute Clinical Center of Serbia

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: CardioFiT™ for Heart Failure - Safety and Efficacy Study Protocol

Congestive Heart Failure is the result of a number of diseases affecting the heart, causing the heart's failure to properly meet the body demands for blood circulation. In spite of advances in drug therapy, it remains a significant public health problem.

Pharmacologic antagonism of the beta-adrenergic receptors shifting the autonomic balance in the direction of greater vagal influence is a well-proven treatment for heart failure patients, although there are patients who cannot tolerate, or only partially benefit from such a treatment.

Read more

It has been proven in the past and well established that parasympathetic nerve stimulation can slow the rate of the heart and reduce the workload of the heart. Therefore, the potential benefit of vagus nerve stimulation, hence parasympathetic activation, for treatment of heart failure is substantial.

In this study, the safety and efficacy of a new vagus nerve stimulating system will be evaluated. This study will compare whether the new device improves Heart Failure parameters in Class II - III Heart Failure patients.

Read the detailed description
  • Purpose of the study: To determine the safety and efficacy of the CardioFit™ system for treatment of Class II-III Heart Failure patients.
  • Study hypothesis: CardioFit system treatment will improve patients Heart Failure parameters.
  • Tested hypothesis: Thirty patients are required to provide 80% power at 95% confidence level in order to detect 12 points difference on a quality of life questionnaire between pre- and post activation.
  • Design: Prospective, self-controlled interventional study composed of 5 periods: Pre-implantation, Implantation, Device activation, Follow-up (with active device) and post-study extension period.
  • Study duration is 7.5-months per patient. At the end of the study, patients enter an extension period (with active devices) during which they will be monitored for quality of life and survival, for up to 3 years post-implantation in 6-months intervals.
  • Study Endpoints:
  • Primary endpoints: The occurrence of all system and/or procedure related adverse events.
  • Secondary endpoints: changes in the following individual variables as well as in a composite score of individual variables change: NYHA class; Quality of Life; Exercise capacity (by 6-min walk); LV Ejection fraction; LV end-systolic and end-diastolic volumes; blood tests.
  • Up to 10 participating centers in Europe, Israel and Australia
Conditions
Heart Failure
Being tested
Implantation and activation of the vagus nerve stimulator
Medical subject headings
Heart Failure

What participants receive

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

  • Implantation and activation of the vagus nerve stimulatorProcedure or surgery

    Implantation of the nerve stimulator, cuff nerve electrode and RV sensing lead

Study groups in NCT00461019
Study groupRoleWhat they receive
Implantation of the CardioFit systemExperimentalNot described
Receives: Procedure: Implantation and activation of the vagus nerve stimulator

What is being measured

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

  1. The occurrence of all system and/or procedure related adverse events.

    Measured: along the study

Secondary outcomes (6)

  1. Change in NYHA class

    Measured: At 6-months

  2. Quality of Life

    Measured: At 6-months

  3. Exercise capacity (by 6-min walk)

    Measured: At 6-months

  4. LV Ejection fraction

    Measured: At 6-months

  5. LV end-systolic and end-diastolic volumes

    Measured: At 6-months

  6. Blood tests.

    Measured: At 6-months

Timeline

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

  1. First posted17 Apr 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00461019
Sponsor's protocol ID
CF-MS-01
Status last verified
Mar 2011
First submitted
16 Apr 2007
Last updated
7 Mar 2011
Results posted
No
Data monitoring committee
No

Publications

  • De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J, Raspopovic S, Klein H, Swedberg K, Schwartz PJ; CardioFit Multicenter Trial Investigators. Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure. Eur Heart J. 2011 Apr;32(7):847-55. doi: 10.1093/eurheartj/ehq391. Epub 2010 Oct 28.

    PubMed 21030409

  • Schwartz PJ, De Ferrari GM, Sanzo A, Landolina M, Rordorf R, Raineri C, Campana C, Revera M, Ajmone-Marsan N, Tavazzi L, Odero A. Long term vagal stimulation in patients with advanced heart failure: first experience in man. Eur J Heart Fail. 2008 Sep;10(9):884-91. doi: 10.1016/j.ejheart.2008.07.016. Epub 2008 Aug 28.

    PubMed 18760668

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Implantation and activation of the vagus nerve stimulator in people with Heart Failure, run by BioControl Medical at 6 sites in 4 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 8 inclusion and 26 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 7 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, Italy, Netherlands, Serbia. 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 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.

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?

The occurrence of all system and/or procedure related adverse events. (time frame: along the study). 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 NCT00461019, which also lists 2 linked publications.

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 7 Mar 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in