Multicenter Study of Immunoadsorption in Dilated Cardiomyopathy (IMPACT-DCM)

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT00558584
• Date of registration: 14/11/2007
• Prospective Registration: Yes
• Primary sponsor: University Medicine Greifswald
• Public title: Multicenter Study of Immunoadsorption in Dilated Cardiomyopathy (IMPACT-DCM)
• Scientific title: Multicentre, Randomized, Double-blind, Prospective Investigation on the Effects of Immunoadsorption on Cardiac Function in Patients With Dilated Cardiomyopathy
• Date of first enrolment: December 2007
• Target sample size: 180
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00558584
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Germany, Serbia, Sweden

Contacts

• Name: Stephan B Felix, MD
• Affiliation: Ernst-Moritz-Arndt University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Dilated cardiomyopathy

- LVEF <= 40% determined by contrast echocardiography

- NYHA class II - IV

- Age 18 - 70

- Disease duration: symptomatic heart failure = 6 months and <7 years prior to screening
date

- Treatment with ACE inhibitors or angiotensin II receptor blockers (ARB),
beta-blockers, and aldosterone antagonists (the latter at the discretion of the
attending physician), for at least 6 months and at stable doses for at least 2 months
prior to screening date.

- The patient's informed consent

Exclusion Criteria:

- NYHA class IV patients who are bed-ridden and dependent upon parenteral medication

- Cardiac insufficiency resulting from another basic disease (e.g. coronary artery
disease, =50% stenosis of major vessel as ascertained by coronary angiography
performed more recent than three years before screening date, hypertensive heart
disease, or valvular defects >second degree

- History of myocardial infarction

- Acute myocarditis according to Dallas criteria

- Endocrine disorder excluding insulin-dependent diabetes mellitus

- Implanted cardiac defibrillator (ICD) <1 month before screening date

- Cardiac resynchronization therapy (CRT) <6 months before screening date

- I.v. medication with inotropic drugs, vasodilators or repeated (>1/day) i.v.
administration of diuretics.

- Active infectious disease, or signs of ongoing infection with CRP >10mmol/L

- Impaired renal function (serum creatinine >220 µmol/L)

- Any disease requiring immunosuppressive drugs

- Anaemia (haemoglobin below 90 g/L) due to other causes than CHF

- Pregnancy or lactation, or childbearing potential without appropriate contraception

- Alcohol or drug abuse

- Presence of a malignant tumour, or remission of malignancy < 5 years

- Refusal of the patient to provide consent

- Suspected poor capability to follow instructions and cooperate

- Another life-threatening disease with poor prognosis (survival less than 2 years)

- Participation in any other clinical study within less than 30 days prior to screening
date

- Previous treatments with IA or immunoglobulin

- Contraindications for application of the echocardiography contrast agent used (in
accordance to the product specification). [Amendment 8]



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dilated Cardiomyopathy

Intervention(s)

Device: pseudo-immunoadsorption

Device: protein A immunoadsorption

Primary Outcome(s)

Left ventricular ejection fraction (LVEF) at rest, as determined by contrast echocardiography [Time Frame: six months]

Secondary Outcome(s)

Serious clinical adverse events [Time Frame: day 7, 1 month, and 6 months]

Cardiopulmonary exercise capacity [Time Frame: 6, 12, and 24 months]

LVEF at rest, as determined by magnetic resonance imaging (optional) [Time Frame: 6, 12, and 24 months]

Quality of life (MLHFQ) [Time Frame: 6, 12, and 24 months]

Reduction of brain natriuretic peptides (BNP and/or NT pro-BNP) [Time Frame: 6, 12, and 24 months]

Clinical outcome (non-cardiovascular death, cardiovascular death, sudden death, hospitalization for cardiovascular cause/heart failure, acute myocardial infarction, unstable angina, stroke, cardiac interventions/procedures, clinical deterioration) [Time Frame: 24 months]

LVEF at rest, as determined by contrast echocardiography [Time Frame: 12 and 24 months]

Secondary ID(s)

IA-2006-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ENDI-Foundation, Bad Homburg, Germany

Bristol-Myers Squibb

Krupp von Bohlen und Halbach-Foundation, Essen, Germany