Lipoprotein Apheresis in Refractory Angina Study

NCT01796912 | Completed Results DMC

• 1 other identifier: 1880
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine the impact of apheresis on clinical parameters and symptoms of patients with refractory angina and raised Lp(a). The investigators will conduct a prospective, randomised controlled crossover study of 20 patients with refractory angina and raised Lp(a), randomised to undergoing lipoprotein apheresis weekly for three months or sham apheresis weekly for three months with assessment of myocardial perfusion, carotid atherosclerosis, endothelial vascular function, thrombogenesis, exercise capacity, angina symptoms and quality of life at the beginning and end of treatment. Patients will then crossover to the opposite study arm with the protocol repeated. The hypothesis is that the above parameters will be improved by lipoprotein apheresis in patients with raised Lp(a) and Refractory Angina. Investigators will also test for the genotypic presence of apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to be associated with an increased level of Lp(a) and an increased risk of coronary disease.

Conditions

Refractory Angina; Raised Lipoprotein(a)>50mg/dL or >500mg/L

Keywords

Refractory Angina; Lipoprotein

Outcome Measures

Primary Outcomes (1)

• Changes in Quantitative Myocardial Perfusion Measured by Stress/Rest Cardiovascular Magnetic Resonance Imaging

  Baseline compare to 3 month, changes presented Determine the impact of lipoprotein apheresis on quantitative myocardial perfusion measured by stress/rest cardiovascular magnetic resonance imaging. Increase means better outcome

  3 months

Secondary Outcomes (6)

• Change in Carotid Atherosclerosis/Plaque Burden Determined by Cardiovascular Magnetic Resonance Imaging

  3 months

• Change in Endothelial Vascular Function

  Within 7 days before and after 3 months of weekly lipoprotein apheresis

• Change in Seattle Angina Questionnaire Score

  3 months

• Change in SF-36 Quality of Life Score

  3 months

• Change in Exercise Capacity Determined by Six Minute Walk Test

  3 months

Study Arms (2)

First Lipoprotein Apheresis, then sham apheresis

ACTIVE COMPARATOR

Three months of weekly lipoprotein apheresis, 1 month washout, then three month sham apheresis

Other: Lipoprotein Apheresis

First Sham Apheresis, then Lipoprotein Apheresis

SHAM COMPARATOR

Three months of weekly sham apheresis, 1 month washout, then three month lipoprotein Apheresis

Other: Sham Apheresis

Interventions

Lipoprotein Apheresis OTHER

Weekly lipoprotein apheresis for 3 months

First Lipoprotein Apheresis, then sham apheresis

Sham Apheresis OTHER

Weekly sham (placebo) apheresis for 3 months

First Sham Apheresis, then Lipoprotein Apheresis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with refractory angina for more than three months.
• Two or more episodes of angina per week.
• Previous history of myocardial infarction, coronary artery bypass graft (CABG) surgery,percutaneous coronary intervention (PCI) or any combination of the above.
• Prescribed optimal medical therapy.
• Hypercholesterolaemia with an elevated Lp(a) \> 50mg/dL and an LDL-cholesterol less than 4.0mmol/L despite optimal lipid lowering drug therapy.

You may not qualify if:

• Patients with poor calibre veins for cannulation.
• Patients with any other chronic systemic illness such as liver or renal failure, neoplastic disease, overt cardiac failure, unstable coronary artery disease, coronary revascularisation or a myocardial infarction within the previous eight weeks.
• Pregnancy, untreated diabetes mellitus, untreated arterial hypertension, and those with general contraindications to undergoing Cardiovascular magnetic resonance imaging or contraindications to adenosine.

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

• Khan TZ, Hsu LY, Arai AE, Rhodes S, Pottle A, Wage R, Banya W, Gatehouse PD, Giri S, Collins P, Pennell DJ, Barbir M. Apheresis as novel treatment for refractory angina with raised lipoprotein(a): a randomized controlled cross-over trial. Eur Heart J. 2017 May 21;38(20):1561-1569. doi: 10.1093/eurheartj/ehx178.

  PMID: 28453721 RESULT

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dudley Pennell
• Organization: Imperiwal College London

d.pennell@imperial.ac.uk

+44 (0)20 3811 6871

Study Officials

• Dudley Pennell, MB BChir MA MD FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Mahmoud Barbir, MB BCh, FRCP

  Royal Brompton and Harfield Hospital, Imperial College

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: February 22, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)