Exercise-induced Pulmonary Hypertension in Patients With Sickle-cell Anemia

NCT00948012 | Completed

• 1 other identifier: HPSC01
• Study Type: observational
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pulmonary hypertension (PH) at rest is a risk factor for death in patients with sickle-cell anemia (SCA). Exercise echocardiography (EE) can detect latent PH. We sought to investigate the occurrence of exercise-induced PH in patients with SCA and normal pulmonary pressure (PP) at rest, and its relationship with clinical and echocardiographic variables.Forty-four patients with SCA and normal PP at rest were studied and divided into two groups: exhibiting normal PP after treadmill EE (TRV≤2.7m/s) (G1), and exhibiting exercise-induced PH (TRV\>2.7m/s) (G2). TRV cutoff points at rest and during exercise were based on data from healthy control subjects, matched for age, sex, and body surface area. Data obtained from EE were correlated with clinical, echocardiographic and ergometric variables.Exercise-induced PH occurred in 57% of the sample (G2), significantly higher than those of G1. Exercise-induced PH was related to higher levels of creatinine (p\<0.05), increased left atrial volume (p\<0.05) and right ventricular diastolic area (p\<0.05), larger E/Em waves ratio derived from spectral and tissue Doppler (p\<0.05), and higher TRV at rest (p\<0.005).We concluded that patients with SCA and normal PP at rest may exhibit exercise-induced PH, which was related to renal function, increased cardiac chambers, abnormal indices of diastolic function and baseline TRV levels.

Conditions

Sickle Cell Anemia; Pulmonary Hypertension

Keywords

Sickle Cell Anemia; Pulmonary Hypertension; Exercise echocardiography; Echocardiography

Outcome Measures

Primary Outcomes (1)

• Exercise-induced pulmonary hypertension

  until one minute after exercise

Study Arms (2)

Patients without pulmonary hypertension

Patients with sickle cell with normal response of pulmonary artery pressure to exercise

Exercise-induced pulmonary hypertension

Patients with sickle-cell anemia with exercise-induced pulmonary hypertension.

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with SCA, homozygous to hemoglobin S with preserved physical capacity, followed at the Hematology and Blood Transfusion Division of the Federal University of Sao Paulo (UNIFESP) or at the Hematology and Oncology Division of Santa Casa de Misericordia de Sao Paulo Medical School.

You may qualify if:

• patients with Sickle Cell Anemia homozygous to hemoglobin S
• preserved physical capacity
• steady state of the disease

You may not qualify if:

• Pulmonary Hypertension at rest
• Recent sickling crisis(\<2 months)
• High Blood Pressure
• Atrial fibrillation
• Chronic obstructive pulmonary disease
• Last blood transfusion \> 3 months before
• Signs of congestive heart failure or significant valve disease
• Normal global and regional systolic function on echocardiography

Sponsors & Collaborators

• Federal University of São Paulo: lead

MeSH Terms

Conditions

Anemia, Sickle Cell; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Orlando C Filho

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: June 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: November 1, 2007
• Last Updated: July 29, 2009

Record last verified: 2009-07