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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00948012
First Posted: July 29, 2009
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  Purpose
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.

Condition
Sickle Cell Anemia Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exercise-induced Pulmonary Hypertension in Patients With Sickle-cell Anemia: an Echocardiographic Study.

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Exercise-induced pulmonary hypertension [ Time Frame: until one minute after exercise ]

Enrollment: 44
Study Start Date: June 2006
Study Completion Date: November 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:
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 (22 men, mean age 25 y.o.) with SCA and normal PP at rest (tricuspid regurgitant jet flow velocity [TRV] <2.5 m/s) 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), with mean TRV level of 3.4±0.4 m/s (range 2.8 - 4.5m/s), significantly higher than those of G1 (2.5±0.3 m/s, p<0.001). 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. The clinical meaning of these findings requires clarification in future studies.
  Eligibility

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948012


Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Chair: Orlando C Filho Federal University of Sao Paulo
  More Information

Responsible Party: Newton Nunes de Lima Filho, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00948012     History of Changes
Other Study ID Numbers: HPSC01
First Submitted: July 28, 2009
First Posted: July 29, 2009
Last Update Posted: July 29, 2009
Last Verified: July 2009

Keywords provided by Federal University of São Paulo:
Sickle Cell Anemia
Pulmonary Hypertension
Exercise echocardiography
Echocardiography

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Lung Diseases
Anemia
Anemia, Sickle Cell
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Respiratory Tract Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn