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

NCT ID: NCT00948012

Last Updated: 2009-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sickle Cell Anemia Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients without pulmonary hypertension

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

No interventions assigned to this group

Exercise-induced pulmonary hypertension

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Federal University of São Paulo

Principal Investigators

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Orlando C Filho

Role: STUDY_CHAIR

Federal University of São Paulo

Other Identifiers

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HPSC01

Identifier Type: -

Identifier Source: org_study_id

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