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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00948012
First received: July 28, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948012

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

No publications provided

Responsible Party: Newton Nunes de Lima Filho, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00948012     History of Changes
Other Study ID Numbers: HPSC01
Study First Received: July 28, 2009
Last Updated: July 28, 2009
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 20, 2014