Microvascular and Cardiac Dysfunction in Paroxysmal Nocturnal Hemoglobinuria and Sickle Cell Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01294891
First received: February 11, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

The purpose of this study is to examine how abnormal blood flow in the small vessels (microvessels) of the heart, muscle and kidney in paroxysmal nocturnal hemoglobinuria (PNH) or sickle cell disease leads to poor functioning of the heart and kidney. To test this question, the investigators will perform imaging tests (contrast ultrasound perfusion imaging) to look at the flow and function of these microvessels and compare this information to heart and kidney function. To further look at this question, patients who have PNH will be studied before and after starting a new drug (Soliris) that decreases damage to blood cells. In patients with sickle cell disease, patients will be studied at baseline (not during a pain crisis) and also during a pain crisis if one develops.


Condition Intervention
Rheologic Disease
Sickle Cell Disease
Paroxysmal Nocturnal Hemoglobinuria
Other: Imaging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Microvascular and Cardiac Dysfunction in Paroxysmal Nocturnal Hemoglobinuria and Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Microvascular perfusion [ Designated as safety issue: No ]
    1. Myocardial microvascular blood flow (MBF) and capillary blood velocity (CBV) on study day.
    2. Renal MBF on study day
    3. Skeletal muscle MBF and CBV on study day
    4. Myocardial MBF and CBV during hyperemia
    5. Skeletal muscle CBV during hyperemia


Estimated Enrollment: 70
Study Start Date: February 2011
Groups/Cohorts Assigned Interventions
Control
Age matched healthy subjects
Other: Imaging
Contrast ultrasound perfusion imaging and complete echocardiography
Sickle Cell Patients
Patients with established SCD
Other: Imaging
Contrast ultrasound perfusion imaging and complete echocardiography
Paroxysmal Nocturnal Hemoglobinuria patients
Patients with PNH
Other: Imaging
Contrast ultrasound perfusion imaging and complete echocardiography

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with SCD or PNH who are seen in the OHSU Hematology clinic and are asked to participate

Criteria

Inclusion Criteria:

  • Established diagnosis of PNH or SCD Age > 18 years old

Exclusion Criteria:

  • Pregnant or lactating women Presence of significant right to left shunting Allergy to ultrasound contrast agent Reactive airways disease Significant peripheral or coronary artery disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294891

Contacts
Contact: Jonathan R Lindner, MD 5034948750 lindnerj@ohsu.edu
Contact: Todd Belcik, RCDS 5034944772 belcikt@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Jonathan R Lindner, MD    503-494-8750    lindnerj@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Jonathan R. Lindner, MD, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01294891     History of Changes
Other Study ID Numbers: IRB00006948
Study First Received: February 11, 2011
Last Updated: February 11, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Rheology
Sickle cell
Paroxysmal nocturnal hemoglobinuria
contrast ultrasound

Additional relevant MeSH terms:
Anemia, Sickle Cell
Hemoglobinuria
Hemoglobinuria, Paroxysmal
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Myelodysplastic Syndromes
Bone Marrow Diseases

ClinicalTrials.gov processed this record on April 23, 2014