Cardiopulmonary Assessment at Rest and during Exercise in patients with Sickle Cell Disease

Not Applicable

Completed

• Conditions: Sickle cell disease; Haematological Disorders; Sickle-cell anaemia without crisis

• Registration Number: ISRCTN63190358
• Lead Sponsor: niversity College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-22
• Study Completion: 2016-01-18
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients with a diagnosis of homozygous sickle cell disease
2. Aged 18 and over

Exclusion Criteria

1. Age outside inclusion criteria
2. Impaired left ventricle (LV) function
3. Valvular abnormalities
4. Sickle cell crisis within 2 weeks of recruitment.
5. Acute chest syndrome within 4 weeks of recruitment
6. Principal exclusion criteria to perform an MR scan:
6.1. Permanent pacemaker
6.2. Intracerebral aneurysm clip
6.3. Pregnancy
7. Physical diabilities which don't permit the patient to ride on a bike
8. Principal exclusion criteria to perform a cardiopulmonary exercise test:
8.1. Myocardial infarction (35 days)
8.2. Syncope
8.3. Uncontrolled heart failure
8.4. Uncontrolled Asthma
8.5. Respiratory failure
8.6. Resting saturations <85%
8.7. Uncontrolled arrythmias
8.8. Active endocarditis, myocarditis, pericarditis

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cardiac Magnetic Imaging can be used to assess pulmonary vascular parameters in SCD patients<br>2. The pulmonary vascular responses to exercise are abnormal in patients with SCD<br><br>Timepoints of measurements: 0 months (baseline) and 12 months (end)

Secondary Outcome Measures

Name	Time	Method
Treatment of SCD with transfusion therapy and 5-hydoxyurea, designed to reduce the proportion of sickle red cells, alter vascular responses to exercise<br><br>Timepoints of measurements: 0 months (baseline), 6 months (mid) and 12 months (end)